<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04420546</url>
  </required_header>
  <id_info>
    <org_study_id>2020-8446-15312</org_study_id>
    <nct_id>NCT04420546</nct_id>
  </id_info>
  <brief_title>Using Implementation Intentions to Reduce Self-harm</brief_title>
  <official_title>Using Implementation Intentions to Reduce Self-harm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present research is to explore whether a brief intervention based on&#xD;
      psychological theory can help people to avoid self-harming. The intervention is the&#xD;
      Volitional Help Sheet (VHS), or &quot;IF-THEN&quot; plans, which will be tested in the context of&#xD;
      trying to reduce self-harm.&#xD;
&#xD;
      Each participant will be randomly allocated to one of two conditions. The two conditions are:&#xD;
      (1) a control condition, and (2) intervention (form multiple implementation intentions from a&#xD;
      drop-down menu). The main outcome measure will be reduction in self-harm, which will be&#xD;
      self-reported&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and study aims The purpose of this study is to explore whether a brief&#xD;
      intervention based on psychological theory can help people to avoid self-harming. The&#xD;
      intervention is the Volitional Help Sheet (VHS), or &quot;IF-THEN&quot; plans, which will be tested in&#xD;
      the context of trying to reduce self-harm. An example of an &quot;IF-THEN&quot; plan is &quot;If I feel the&#xD;
      urge to self-harm when I want to get relief from a terrible state of mind, Then I will do&#xD;
      something else instead of self-harming&quot;. IF-THEN plans work by helping people to link a&#xD;
      critical situation (&quot;If I am tempted to self-harm when I want to get some attention&quot;), to an&#xD;
      appropriate response (&quot;Then I will do something else instead of self-harming&quot;).&#xD;
&#xD;
      Implementation intentions (i.e., making if-then plans) are effective at changing behaviour.&#xD;
      The investigators have had previous success in using the VHS to reduce self-harm in people&#xD;
      recently admitted to hospital for self-harm. The next stage of the research is to explore&#xD;
      whether this intervention is acceptable and effective in the population more generally.&#xD;
&#xD;
      Research shows that if people can spot situations in which they may be tempted to self-harm&#xD;
      and identify ways of overcoming those situations, they are much more likely to be successful&#xD;
      in avoiding self-harming.&#xD;
&#xD;
      Who can participate? Adults aged over 18 years of age, have a history of self-harm, and have&#xD;
      good verbal and written understanding of English What does the study involve? The research&#xD;
      will involve two phases which aim to examine the acceptability and effectiveness of a brief&#xD;
      psychological intervention to reduce self-harm.&#xD;
&#xD;
      Phase 1 Phase 1 involves a wide scale roll out of the VHS, to test the effectiveness of the&#xD;
      VHS in reducing self-harm, and to gather feedback about the acceptability of the&#xD;
      intervention. YouGov (a survey panel company) will collect the data on behalf of the research&#xD;
      team over a period of 6 months (including a baseline and six-month follow-up), and store the&#xD;
      data on a secure server, before sending to the research team. The research team at the&#xD;
      University of Manchester will conduct and analyse the data. A sample of 1,000 people will&#xD;
      take part in Phase 1 and will be randomly allocated to receive either the Volitional Help&#xD;
      Sheet (intervention group; to make links between situations and solutions), or a control&#xD;
      group (using the same intervention, but for a different behaviour [increasing physical&#xD;
      activity]).&#xD;
&#xD;
      Participants will firstly be asked to complete a short series of demographic questions and&#xD;
      questions to assess any psychological aspects involved in self-harm. Participants will also&#xD;
      be asked about history of self-harm and will be presented with a VHS. Participants in the&#xD;
      intervention group will then be asked to construct &quot;IF-THEN plans&quot; for self-harm;&#xD;
      participants in the control group will be asked to construct &quot;IF-THEN plans&quot; for increasing&#xD;
      physical activity. After participants have been exposed to the VHS, they will be invited to&#xD;
      complete a series of questions about their experiences of the VHS and taking part in the&#xD;
      study generally. These questions are to assess the feasibility and acceptability of the VHS.&#xD;
      All questions will be optional, and participants can choose to skip any should they desire.&#xD;
      Likert scale responses and open-ended text fields have been created based on a published&#xD;
      framework.&#xD;
&#xD;
      The investigators have gathered some detailed feedback on the VHS from a Patient and Public&#xD;
      Involvement and Engagement (PPI/E) group. This group have been specifically trained to&#xD;
      provide feedback on research and materials to be used as part of intervention delivery. All&#xD;
      members of this group have a history of self-harm. The feedback has been used to ensure the&#xD;
      VHS is understandable and sensitive to people's thoughts and emotions. The modified version&#xD;
      of the VHS will be implemented in this study.&#xD;
&#xD;
      Participants will be invited to take part in a 6-month follow-up to test the effectiveness of&#xD;
      the intervention on recurrence of self-harming. In both the baseline and follow-up&#xD;
      questionnaires, YouGov will collect the data on behalf of the research team. YouGov will&#xD;
      ensure that all data collected is stored confidentially in accordance with their privacy&#xD;
      policy, which participants can view here https://yougov.co.uk/about/terms-combined/#/privacy.&#xD;
      Data will be anonymised and sent to the research team at the University of Manchester, where&#xD;
      all information will be kept confidential and will conform to the 'Data Protection Act of&#xD;
      1998' with respect to data collection, storage and destruction. Participants' data will be&#xD;
      kept separately in secure databases. The participants involved in phase 1 will be recruited&#xD;
      as part of a pre-determined sampling frame (developed by YouGov and The University of&#xD;
      Manchester), which is intended to be representative of people in the UK who have previously&#xD;
      self-harmed.&#xD;
&#xD;
      Phase 2 In between the baseline and follow-up data collected in Phase 1, the investigators&#xD;
      will collect an additional round of data on the acceptability of the intervention.&#xD;
&#xD;
      In phase 2 participants will be recruited though online self-harm fora (for example the&#xD;
      national Self-harm Network; https://www.nshn.co.uk) and will be invited to complete an online&#xD;
      questionnaire. Study adverts will be placed on dedicated pages on each of the fora. The same&#xD;
      questionnaire that was used in Phase 1 will be used in Phase 2. As an additional component to&#xD;
      phase 2 of the research, participants will be given the option to take part in a short&#xD;
      semi-structured telephone interview to discuss the research in further detail. This is&#xD;
      entirely optional and if participants do wish to take part, the interview will be conducted&#xD;
      at a time and date convenient for them. The interview questions are based on the&#xD;
      acceptability questions asked during the questionnaire. If participants wish to take part&#xD;
      they will be asked to provide their email address so a member of the research team can&#xD;
      contact them to arrange the interview. Based on the findings of Phases 1 and 2 the&#xD;
      intervention will be modified and result in a final version of the VHS.&#xD;
&#xD;
      What are the possible benefits and risks of participating? By taking part participants will&#xD;
      be helping to understand more about brief interventions to reduce self-harm. By constructing&#xD;
      their own &quot;IF-THEN&quot; plans participants are encouraged to construct their own action plans to&#xD;
      deal with potential situations where they may be tempted to self-harm.&#xD;
&#xD;
      There are two ethical issues which may arise:&#xD;
&#xD;
        1. Past research indicates that participating in research around self-harm is often a&#xD;
           largely positive experience and negative reactions are rare. Our experience running a&#xD;
           previous trial using the same intervention as the one in the present application&#xD;
           confirms that adverse events are rare. However, there is a low risk of some participants&#xD;
           finding the volitional help sheet, which focuses on participants identifying situations&#xD;
           where they may feel the urge to self-harm, difficult as it may induce uncomfortable&#xD;
           emotions or result in distress.&#xD;
&#xD;
        2. Participants will have a history of self-harm and it is possible that participants will&#xD;
           engage in self-harm during or following the study. This risk therefore requires&#xD;
           management.&#xD;
&#xD;
      The specific steps taken to address the above are as follows:&#xD;
&#xD;
        1. Steps have been taken to minimize the possible risks identified in this study: All&#xD;
           participants will be informed of the possible risk of distress in the Participant&#xD;
           Information Sheet. This form will be available to participants online before deciding to&#xD;
           take part in the study. Full contact details of the research team will also be provided&#xD;
           should participants wish to discuss any queries before they are asked to consent to take&#xD;
           part. It will also be suggested to participants that if they feel that taking part in&#xD;
           the study will induce significant emotional distress or could increase feelings related&#xD;
           to self-harm then they may not want to take part.&#xD;
&#xD;
           All participants will be informed they do not need to answer any questions they do not&#xD;
           wish to, and will be free to withdraw from the study at any time without detriment to&#xD;
           themselves. Participants will be advised to withdraw from the study at any point should&#xD;
           they become distressed (possibly stopping altogether, or taking a break depending on how&#xD;
           the participant wants to proceed).&#xD;
&#xD;
           Where participants experience significant distress they will be encouraged to speak with&#xD;
           their General Practitioner about this at the earliest opportunity.&#xD;
&#xD;
        2. It is reasonable to expect that some participants will engage in self-harm during the&#xD;
           course of the study. Due to the participants being able to take part in this study&#xD;
           anonymously, the investigators are not able to inform their clinicians. In line with&#xD;
           point (1), if participants experience significant distress or emotional discomfort they&#xD;
           will be encouraged to speak with their General Practitioner about this to ensure they&#xD;
           receive appropriate support and advice. A list of contact numbers of charities and&#xD;
           organisations will also be provided as part of the Participant Information Sheet.&#xD;
&#xD;
      In the case that participants indicate to the researcher (for example if a participant phones&#xD;
      or emails the researcher) at any point that they plan to seriously harm themselves, a risk&#xD;
      and safety plan protocol will be followed (see attached document). This includes a series of&#xD;
      steps to determine the level of risk (low-immediate) and appropriate action plans. Action&#xD;
      plans include following a safety plan with the participant, providing emergency contact&#xD;
      numbers and contacting clinical colleagues and/or emergency services if immediate risk is&#xD;
      expressed (in cases where participants have supplied their contact details). These steps may&#xD;
      include the need to break confidentiality, by, for example, informing the emergency services.&#xD;
      In such cases this breaking of confidentiality would be discussed with participants, unless&#xD;
      there is judged a likelihood that this discussion itself could increase risk.&#xD;
&#xD;
      Participants will be informed of the possibility of confidentiality being broken in this&#xD;
      manner in the participant information sheet, prior to consent being sought.&#xD;
&#xD;
      All instances of participants signalling either intent/planning of a serious act of self-harm&#xD;
      (i.e. a suicide attempt or self-injury liable to require medical intervention) or reporting&#xD;
      actual engagement in these behaviours will be treated as a serious adverse event and standard&#xD;
      University of Manchester recording practices would be followed (these can be accessed at:&#xD;
      https://www.manchester.ac.uk/research/environment/governance/policies-guidelines/).&#xD;
&#xD;
      Where is the study run from?&#xD;
&#xD;
      The University of Manchester (UK)&#xD;
&#xD;
      When is the study starting and how long is it expected to run for?&#xD;
&#xD;
      May 2020 to December 2020&#xD;
&#xD;
      Who is funding the study?&#xD;
&#xD;
      The study is funded by the National Institute for Health Research.&#xD;
&#xD;
      Who is the main contact?&#xD;
&#xD;
        1. Dr Chris Keyworth Chris.keyworth@manchester.ac.uk&#xD;
&#xD;
        2. Prof Christopher J. Armitage Chris.armitage@manchester.ac.uk&#xD;
&#xD;
      Scientific title&#xD;
&#xD;
      Using IF-THEN plans to reduce self-harm&#xD;
&#xD;
      Study hypothesis&#xD;
&#xD;
      Current study hypothesis as of 19/03/2020:&#xD;
&#xD;
      People who form implementation intentions using the volitional help sheet will report reduced&#xD;
      self-harm and suicidal ideation at follow-up compared with people in the control condition.&#xD;
&#xD;
      Any effects of the intervention will be mediated principally through increases in automatic&#xD;
      motivation and changes in habits.&#xD;
&#xD;
      Study design Mixed methods study. Primary study design Interventional; two-arm randomised&#xD;
      controlled trial.&#xD;
&#xD;
      Secondary study design Qualitative study Trial type Prevention Patient information sheet Not&#xD;
      available in web format, please use contact details to request a participant information&#xD;
      sheet.&#xD;
&#xD;
      Condition Self-harm Intervention&#xD;
&#xD;
      Participants complete a series of questionnaires about their history of self-harm and are&#xD;
      then randomly assigned to one of the two conditions:&#xD;
&#xD;
        1. The volitional help sheet includes a list of situations when people might not want to be&#xD;
           physically active (e.g., &quot;If I feel the urge to self-harm when I want to get relief from&#xD;
           a terrible state of mind&quot;) and a list of solutions to overcoming these (e.g., &quot;then I&#xD;
           will do something else instead of self-harming&quot;). Participants are asked to make a link&#xD;
           (using drop-down menus as part of the online questionnaire) from the situations that are&#xD;
           relevant to them to their chosen solutions. They can create as many situation and&#xD;
           solution pairs as they want.&#xD;
&#xD;
        2. The control condition includes the same intervention but for a different target&#xD;
           behaviour (increasing physical activity).&#xD;
&#xD;
      After 6 months participants are asked the history of self-harm questions to see if the&#xD;
      intervention has reduced self-harm.&#xD;
&#xD;
      Intervention type Behavioural Primary outcome measure&#xD;
&#xD;
      1. Non-suicidal self-harm (NSSH) and suicidal ideation and suicide attempts are measured at&#xD;
      baseline and 6 months follow-up using three items drawn from the British Psychiatric&#xD;
      Morbidity Survey 'Have you ever seriously thought of taking your life, but not actually&#xD;
      attempted to do so?' (Suicidal ideation), 'Have you ever made an attempt to take your life,&#xD;
      by taking an overdose of tablets or in some other way?' (Suicidal attempt), and 'Have you&#xD;
      ever deliberately harmed yourself in any way but not with the intention of killing yourself?&#xD;
      (i.e., self-harm)' (NSSH). Response options for all questions are 'Yes' or 'No'. If&#xD;
      respondents answer yes to any of the three questions, timing of last episode and frequency&#xD;
      will be asked.&#xD;
&#xD;
      Secondary outcome measures&#xD;
&#xD;
        1. Exposure to suicide and mental imagery about death is measured at baseline and follow-up&#xD;
           using seven items adapted from those used in the literature previously&#xD;
&#xD;
        2. Capability, opportunity and motivation (based on COM-B model) is measured using the COM&#xD;
           questionnaire at baseline and 6 months follow up&#xD;
&#xD;
        3. Habit is measured using the self-reported habit index (automaticity scale) at baseline&#xD;
           and 6 months follow up&#xD;
&#xD;
        4. State self-regulation is measured at baseline and 6 months follow up. Items are adapted&#xD;
           from those used previously.&#xD;
&#xD;
        5. Frequencies with which critical situations were encountered and appropriate responses&#xD;
           were used.&#xD;
&#xD;
      Data analysis plan Randomisation checks The investigators will run tests on all outcome and&#xD;
      demographic variables to determine if there are any baseline differences in any of these&#xD;
      between conditions: chi square will be used for categorical variables and ANOVA for&#xD;
      continuous variables.&#xD;
&#xD;
      The effect of the intervention on frequency of NSSH, suicidal ideation and suicide attempts&#xD;
      will be tested using three mixed-measures ANCOVAs with condition (intervention versus&#xD;
      control) as the between participants variable and time (baseline versus 6-month follow-up) as&#xD;
      the within-participants variable. Planned contrasts will be used to clarify the anticipated&#xD;
      time x condition interactions. For each of these three analyses SES, age and gender will be&#xD;
      used as covariates.&#xD;
&#xD;
      Three mediation analyses will be conducted using the Hayes mediation model in SPSS with&#xD;
      condition (2 levels: intervention versus control) as the independent variable, and (i) NSSH,&#xD;
      (ii) suicidal ideation, (iii) suicide attempts as the dependent variables. The investigators&#xD;
      will use regression analyses to compute residual scores that will capture any changes between&#xD;
      baseline and follow-up. Thus, changes in exposure, impulsivity, habits, self-regulation&#xD;
      (awareness of standards, self-monitoring and self-regulatory effort), and COM (capabilities,&#xD;
      opportunities and motivations) will be tested as mediators. For each of these three mediation&#xD;
      analyses SES, age and gender will be used as covariates.&#xD;
&#xD;
      Moderator analysis will be conducted to identify whether differential effects across the&#xD;
      conditions exist depending upon: impulsivity, which is measured using the Barratt&#xD;
      impulsiveness scale, anxiety related to COVID-19, which is measured using the Fear of&#xD;
      COVID-19 Scale and Impact of Event Scale at baseline. Physical activity will be compared&#xD;
      across groups at follow-up using the International Physical Activity Questionnaire (short&#xD;
      form).&#xD;
&#xD;
      Scoring the main outcome measures Non-suicidal self-harm (NSSH) and suicidal ideation and&#xD;
      suicide attempts NSSH, suicidal ideation and suicide attempts are calculated as binary&#xD;
      variables ('yes' or 'no). Frequency of suicidal thoughts will be calculated as continuous&#xD;
      variables.&#xD;
&#xD;
      Impulsivity Total score Exposure to suicide and mental imagery about death Exposure to&#xD;
      suicide is calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be&#xD;
      calculated as a total score.&#xD;
&#xD;
      COM (capabilities, opportunities and motivations) Each of the items will be analysed&#xD;
      separately as these each measure a separate construct.&#xD;
&#xD;
      Self-regulation Mean of the two items for each of three sub-constructs: awareness of&#xD;
      standards, self-monitoring, and self-regulatory effort.&#xD;
&#xD;
      Habits Mean of the four items. Frequencies with which critical situations were encountered&#xD;
      and appropriate responses were used Total scores Qualitative study For the follow-up&#xD;
      qualitative interview component (used specifically in phase 2), thematic analysis will be&#xD;
      used to further explore the issues identified in the online questionnaire, and the&#xD;
      experiences of using the Volitional Help Sheet (i.e. making &quot;IF-THEN&quot; plans) to reduce&#xD;
      self-harm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">March 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Non-suicidal self-harm</measure>
    <time_frame>6 months</time_frame>
    <description>'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Suicidal ideation</measure>
    <time_frame>6 months</time_frame>
    <description>'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>suicide attempts</measure>
    <time_frame>6 months</time_frame>
    <description>'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Exposure to suicide and mental imagery about death</measure>
    <time_frame>6 months</time_frame>
    <description>Measured at baseline and follow-up using seven items adapted from those used in the literature previously (https://pubmed.ncbi.nlm.nih.gov/26247914/). Calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be calculated as a total score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)</measure>
    <time_frame>6 months</time_frame>
    <description>Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habit</measure>
    <time_frame>6 months</time_frame>
    <description>Measured using the self-reported habit index (automaticity scale; https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-9-102). This consists of four items (each from 1 to 7). Items are scored from 1 to 7, with a higher mean score indicating higher agreement with the statements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State self-regulation</measure>
    <time_frame>6 months</time_frame>
    <description>Items are adapted from those used previously (https://www.tandfonline.com/doi/abs/10.1080/08870440512331317670).&#xD;
Mean of the two items for each of three sub-constructs: awareness of standards, self-monitoring, and self-regulatory effort. Items are scored from 1 to 7, with higher scores indicating higher agreement with the statements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequencies with which critical situations were encountered and appropriate responses were used</measure>
    <time_frame>6 months</time_frame>
    <description>Frequencies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1040</enrollment>
  <condition>Self-Harm</condition>
  <arm_group>
    <arm_group_label>Control (volitional help sheet)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants read a brief statement designed to encourage them to be more physically active (&quot;We want you to plan to increase your level of physical activity&quot;). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted not to be physically active and identifying ways to overcome those temptations had been shown to help people change their behaviour.&#xD;
Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (volitional help sheet)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants read a brief statement designed to encourage them to avoid self-harming (&quot;We want you to plan to avoid self-harming&quot;). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour.&#xD;
Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volitional help sheet</intervention_name>
    <description>Participants are asked to choose from a list of strategies for increasing physical activity</description>
    <arm_group_label>Control (volitional help sheet)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volitional help sheet</intervention_name>
    <description>Participants are asked to choose from a list of strategies for avoiding self-harm</description>
    <arm_group_label>Intervention (volitional help sheet)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 and over&#xD;
&#xD;
          -  Have a history of self-harm&#xD;
&#xD;
          -  Good verbal and written understanding of English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged under 18 years of age&#xD;
&#xD;
          -  No history of self-harm&#xD;
&#xD;
          -  Poor verbal and written understanding of English&#xD;
&#xD;
          -  Not currently resident of an inpatient facility for mental illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9PL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>http://doc.ukdataservice.ac.uk/doc/6379/mrdoc/pdf/6379_apms_2007_research_report.pdf</url>
    <description>Adult psychiatric morbidity in England, 2007</description>
  </link>
  <reference>
    <citation>O'Connor RC, Ferguson E, Scott F, Smyth R, McDaid D, Park AL, Beautrais A, Armitage CJ. A brief psychological intervention to reduce repetition of self-harm in patients admitted to hospital following a suicide attempt: a randomised controlled trial. Lancet Psychiatry. 2017 Jun;4(6):451-460. doi: 10.1016/S2215-0366(17)30129-3. Epub 2017 Apr 20.</citation>
    <PMID>28434871</PMID>
  </reference>
  <reference>
    <citation>Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.</citation>
    <PMID>28126032</PMID>
  </reference>
  <reference>
    <citation>Biddle L, Cooper J, Owen-Smith A, Klineberg E, Bennewith O, Hawton K, Kapur N, Donovan J, Gunnell D. Qualitative interviewing with vulnerable populations: individuals' experiences of participating in suicide and self-harm based research. J Affect Disord. 2013 Mar 5;145(3):356-62. doi: 10.1016/j.jad.2012.08.024. Epub 2012 Sep 25.</citation>
    <PMID>23021191</PMID>
  </reference>
  <reference>
    <citation>Dhingra K, Boduszek D, O'Connor RC. Differentiating suicide attempters from suicide ideators using the Integrated Motivational-Volitional model of suicidal behaviour. J Affect Disord. 2015 Nov 1;186:211-8. doi: 10.1016/j.jad.2015.07.007. Epub 2015 Jul 29.</citation>
    <PMID>26247914</PMID>
  </reference>
  <reference>
    <citation>O'Connor RC, Rasmussen S, Hawton K. Distinguishing adolescents who think about self-harm from those who engage in self-harm. Br J Psychiatry. 2012 Apr;200(4):330-5. doi: 10.1192/bjp.bp.111.097808. Epub 2012 Mar 8.</citation>
    <PMID>22403089</PMID>
  </reference>
  <reference>
    <citation>Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations (&quot;COM-B&quot;). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20.</citation>
    <PMID>32314500</PMID>
  </reference>
  <reference>
    <citation>Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.</citation>
    <PMID>8778124</PMID>
  </reference>
  <reference>
    <citation>Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.</citation>
    <PMID>32226353</PMID>
  </reference>
  <reference>
    <citation>Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.</citation>
    <PMID>12900694</PMID>
  </reference>
  <reference>
    <citation>Vanaken L, Scheveneels S, Belmans E, Hermans D. Validation of the Impact of Event Scale With Modifications for COVID-19 (IES-COVID19). Front Psychiatry. 2020 Jul 28;11:738. doi: 10.3389/fpsyt.2020.00738. eCollection 2020.</citation>
    <PMID>32848918</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>January 12, 2022</last_update_submitted>
  <last_update_submitted_qc>January 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Dr Chris Keyworth</investigator_full_name>
    <investigator_title>Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04420546
org study id: 2020-8446-15312
nct id: NCT04420546
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of the present research is to explore whether a brief intervention based on
      psychological theory can help people to avoid self-harming. The intervention is the
      Volitional Help Sheet (VHS), or "IF-THEN" plans, which will be tested in the context of
      trying to reduce self-harm.

      Each participant will be randomly allocated to one of two conditions. The two conditions are:
      (1) a control condition, and (2) intervention (form multiple implementation intentions from a
      drop-down menu). The main outcome measure will be reduction in self-harm, which will be
      self-reported
Background and study aims The purpose of this study is to explore whether a brief
      intervention based on psychological theory can help people to avoid self-harming. The
      intervention is the Volitional Help Sheet (VHS), or "IF-THEN" plans, which will be tested in
      the context of trying to reduce self-harm. An example of an "IF-THEN" plan is "If I feel the
      urge to self-harm when I want to get relief from a terrible state of mind, Then I will do
      something else instead of self-harming". IF-THEN plans work by helping people to link a
      critical situation ("If I am tempted to self-harm when I want to get some attention"), to an
      appropriate response ("Then I will do something else instead of self-harming").

      Implementation intentions (i.e., making if-then plans) are effective at changing behaviour.
      The investigators have had previous success in using the VHS to reduce self-harm in people
      recently admitted to hospital for self-harm. The next stage of the research is to explore
      whether this intervention is acceptable and effective in the population more generally.

      Research shows that if people can spot situations in which they may be tempted to self-harm
      and identify ways of overcoming those situations, they are much more likely to be successful
      in avoiding self-harming.

      Who can participate? Adults aged over 18 years of age, have a history of self-harm, and have
      good verbal and written understanding of English What does the study involve? The research
      will involve two phases which aim to examine the acceptability and effectiveness of a brief
      psychological intervention to reduce self-harm.

      Phase 1 Phase 1 involves a wide scale roll out of the VHS, to test the effectiveness of the
      VHS in reducing self-harm, and to gather feedback about the acceptability of the
      intervention. YouGov (a survey panel company) will collect the data on behalf of the research
      team over a period of 6 months (including a baseline and six-month follow-up), and store the
      data on a secure server, before sending to the research team. The research team at the
      University of Manchester will conduct and analyse the data. A sample of 1,000 people will
      take part in Phase 1 and will be randomly allocated to receive either the Volitional Help
      Sheet (intervention group; to make links between situations and solutions), or a control
      group (using the same intervention, but for a different behaviour [increasing physical
      activity]).

      Participants will firstly be asked to complete a short series of demographic questions and
      questions to assess any psychological aspects involved in self-harm. Participants will also
      be asked about history of self-harm and will be presented with a VHS. Participants in the
      intervention group will then be asked to construct "IF-THEN plans" for self-harm;
      participants in the control group will be asked to construct "IF-THEN plans" for increasing
      physical activity. After participants have been exposed to the VHS, they will be invited to
      complete a series of questions about their experiences of the VHS and taking part in the
      study generally. These questions are to assess the feasibility and acceptability of the VHS.
      All questions will be optional, and participants can choose to skip any should they desire.
      Likert scale responses and open-ended text fields have been created based on a published
      framework.

      The investigators have gathered some detailed feedback on the VHS from a Patient and Public
      Involvement and Engagement (PPI/E) group. This group have been specifically trained to
      provide feedback on research and materials to be used as part of intervention delivery. All
      members of this group have a history of self-harm. The feedback has been used to ensure the
      VHS is understandable and sensitive to people's thoughts and emotions. The modified version
      of the VHS will be implemented in this study.

      Participants will be invited to take part in a 6-month follow-up to test the effectiveness of
      the intervention on recurrence of self-harming. In both the baseline and follow-up
      questionnaires, YouGov will collect the data on behalf of the research team. YouGov will
      ensure that all data collected is stored confidentially in accordance with their privacy
      policy, which participants can view here https://yougov.co.uk/about/terms-combined/#/privacy.
      Data will be anonymised and sent to the research team at the University of Manchester, where
      all information will be kept confidential and will conform to the 'Data Protection Act of
      1998' with respect to data collection, storage and destruction. Participants' data will be
      kept separately in secure databases. The participants involved in phase 1 will be recruited
      as part of a pre-determined sampling frame (developed by YouGov and The University of
      Manchester), which is intended to be representative of people in the UK who have previously
      self-harmed.

      Phase 2 In between the baseline and follow-up data collected in Phase 1, the investigators
      will collect an additional round of data on the acceptability of the intervention.

      In phase 2 participants will be recruited though online self-harm fora (for example the
      national Self-harm Network; https://www.nshn.co.uk) and will be invited to complete an online
      questionnaire. Study adverts will be placed on dedicated pages on each of the fora. The same
      questionnaire that was used in Phase 1 will be used in Phase 2. As an additional component to
      phase 2 of the research, participants will be given the option to take part in a short
      semi-structured telephone interview to discuss the research in further detail. This is
      entirely optional and if participants do wish to take part, the interview will be conducted
      at a time and date convenient for them. The interview questions are based on the
      acceptability questions asked during the questionnaire. If participants wish to take part
      they will be asked to provide their email address so a member of the research team can
      contact them to arrange the interview. Based on the findings of Phases 1 and 2 the
      intervention will be modified and result in a final version of the VHS.

      What are the possible benefits and risks of participating? By taking part participants will
      be helping to understand more about brief interventions to reduce self-harm. By constructing
      their own "IF-THEN" plans participants are encouraged to construct their own action plans to
      deal with potential situations where they may be tempted to self-harm.

      There are two ethical issues which may arise:

        1. Past research indicates that participating in research around self-harm is often a
           largely positive experience and negative reactions are rare. Our experience running a
           previous trial using the same intervention as the one in the present application
           confirms that adverse events are rare. However, there is a low risk of some participants
           finding the volitional help sheet, which focuses on participants identifying situations
           where they may feel the urge to self-harm, difficult as it may induce uncomfortable
           emotions or result in distress.

        2. Participants will have a history of self-harm and it is possible that participants will
           engage in self-harm during or following the study. This risk therefore requires
           management.

      The specific steps taken to address the above are as follows:

        1. Steps have been taken to minimize the possible risks identified in this study: All
           participants will be informed of the possible risk of distress in the Participant
           Information Sheet. This form will be available to participants online before deciding to
           take part in the study. Full contact details of the research team will also be provided
           should participants wish to discuss any queries before they are asked to consent to take
           part. It will also be suggested to participants that if they feel that taking part in
           the study will induce significant emotional distress or could increase feelings related
           to self-harm then they may not want to take part.

           All participants will be informed they do not need to answer any questions they do not
           wish to, and will be free to withdraw from the study at any time without detriment to
           themselves. Participants will be advised to withdraw from the study at any point should
           they become distressed (possibly stopping altogether, or taking a break depending on how
           the participant wants to proceed).

           Where participants experience significant distress they will be encouraged to speak with
           their General Practitioner about this at the earliest opportunity.

        2. It is reasonable to expect that some participants will engage in self-harm during the
           course of the study. Due to the participants being able to take part in this study
           anonymously, the investigators are not able to inform their clinicians. In line with
           point (1), if participants experience significant distress or emotional discomfort they
           will be encouraged to speak with their General Practitioner about this to ensure they
           receive appropriate support and advice. A list of contact numbers of charities and
           organisations will also be provided as part of the Participant Information Sheet.

      In the case that participants indicate to the researcher (for example if a participant phones
      or emails the researcher) at any point that they plan to seriously harm themselves, a risk
      and safety plan protocol will be followed (see attached document). This includes a series of
      steps to determine the level of risk (low-immediate) and appropriate action plans. Action
      plans include following a safety plan with the participant, providing emergency contact
      numbers and contacting clinical colleagues and/or emergency services if immediate risk is
      expressed (in cases where participants have supplied their contact details). These steps may
      include the need to break confidentiality, by, for example, informing the emergency services.
      In such cases this breaking of confidentiality would be discussed with participants, unless
      there is judged a likelihood that this discussion itself could increase risk.

      Participants will be informed of the possibility of confidentiality being broken in this
      manner in the participant information sheet, prior to consent being sought.

      All instances of participants signalling either intent/planning of a serious act of self-harm
      (i.e. a suicide attempt or self-injury liable to require medical intervention) or reporting
      actual engagement in these behaviours will be treated as a serious adverse event and standard
      University of Manchester recording practices would be followed (these can be accessed at:
      https://www.manchester.ac.uk/research/environment/governance/policies-guidelines/).

      Where is the study run from?

      The University of Manchester (UK)

      When is the study starting and how long is it expected to run for?

      May 2020 to December 2020

      Who is funding the study?

      The study is funded by the National Institute for Health Research.

      Who is the main contact?

        1. Dr Chris Keyworth Chris.keyworth@manchester.ac.uk

        2. Prof Christopher J. Armitage Chris.armitage@manchester.ac.uk

      Scientific title

      Using IF-THEN plans to reduce self-harm

      Study hypothesis

      Current study hypothesis as of 19/03/2020:

      People who form implementation intentions using the volitional help sheet will report reduced
      self-harm and suicidal ideation at follow-up compared with people in the control condition.

      Any effects of the intervention will be mediated principally through increases in automatic
      motivation and changes in habits.

      Study design Mixed methods study. Primary study design Interventional; two-arm randomised
      controlled trial.

      Secondary study design Qualitative study Trial type Prevention Patient information sheet Not
      available in web format, please use contact details to request a participant information
      sheet.

      Condition Self-harm Intervention

      Participants complete a series of questionnaires about their history of self-harm and are
      then randomly assigned to one of the two conditions:

        1. The volitional help sheet includes a list of situations when people might not want to be
           physically active (e.g., "If I feel the urge to self-harm when I want to get relief from
           a terrible state of mind") and a list of solutions to overcoming these (e.g., "then I
           will do something else instead of self-harming"). Participants are asked to make a link
           (using drop-down menus as part of the online questionnaire) from the situations that are
           relevant to them to their chosen solutions. They can create as many situation and
           solution pairs as they want.

        2. The control condition includes the same intervention but for a different target
           behaviour (increasing physical activity).

      After 6 months participants are asked the history of self-harm questions to see if the
      intervention has reduced self-harm.

      Intervention type Behavioural Primary outcome measure

      1. Non-suicidal self-harm (NSSH) and suicidal ideation and suicide attempts are measured at
      baseline and 6 months follow-up using three items drawn from the British Psychiatric
      Morbidity Survey 'Have you ever seriously thought of taking your life, but not actually
      attempted to do so?' (Suicidal ideation), 'Have you ever made an attempt to take your life,
      by taking an overdose of tablets or in some other way?' (Suicidal attempt), and 'Have you
      ever deliberately harmed yourself in any way but not with the intention of killing yourself?
      (i.e., self-harm)' (NSSH). Response options for all questions are 'Yes' or 'No'. If
      respondents answer yes to any of the three questions, timing of last episode and frequency
      will be asked.

      Secondary outcome measures

        1. Exposure to suicide and mental imagery about death is measured at baseline and follow-up
           using seven items adapted from those used in the literature previously

        2. Capability, opportunity and motivation (based on COM-B model) is measured using the COM
           questionnaire at baseline and 6 months follow up

        3. Habit is measured using the self-reported habit index (automaticity scale) at baseline
           and 6 months follow up

        4. State self-regulation is measured at baseline and 6 months follow up. Items are adapted
           from those used previously.

        5. Frequencies with which critical situations were encountered and appropriate responses
           were used.

      Data analysis plan Randomisation checks The investigators will run tests on all outcome and
      demographic variables to determine if there are any baseline differences in any of these
      between conditions: chi square will be used for categorical variables and ANOVA for
      continuous variables.

      The effect of the intervention on frequency of NSSH, suicidal ideation and suicide attempts
      will be tested using three mixed-measures ANCOVAs with condition (intervention versus
      control) as the between participants variable and time (baseline versus 6-month follow-up) as
      the within-participants variable. Planned contrasts will be used to clarify the anticipated
      time x condition interactions. For each of these three analyses SES, age and gender will be
      used as covariates.

      Three mediation analyses will be conducted using the Hayes mediation model in SPSS with
      condition (2 levels: intervention versus control) as the independent variable, and (i) NSSH,
      (ii) suicidal ideation, (iii) suicide attempts as the dependent variables. The investigators
      will use regression analyses to compute residual scores that will capture any changes between
      baseline and follow-up. Thus, changes in exposure, impulsivity, habits, self-regulation
      (awareness of standards, self-monitoring and self-regulatory effort), and COM (capabilities,
      opportunities and motivations) will be tested as mediators. For each of these three mediation
      analyses SES, age and gender will be used as covariates.

      Moderator analysis will be conducted to identify whether differential effects across the
      conditions exist depending upon: impulsivity, which is measured using the Barratt
      impulsiveness scale, anxiety related to COVID-19, which is measured using the Fear of
      COVID-19 Scale and Impact of Event Scale at baseline. Physical activity will be compared
      across groups at follow-up using the International Physical Activity Questionnaire (short
      form).

      Scoring the main outcome measures Non-suicidal self-harm (NSSH) and suicidal ideation and
      suicide attempts NSSH, suicidal ideation and suicide attempts are calculated as binary
      variables ('yes' or 'no). Frequency of suicidal thoughts will be calculated as continuous
      variables.

      Impulsivity Total score Exposure to suicide and mental imagery about death Exposure to
      suicide is calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be
      calculated as a total score.

      COM (capabilities, opportunities and motivations) Each of the items will be analysed
      separately as these each measure a separate construct.

      Self-regulation Mean of the two items for each of three sub-constructs: awareness of
      standards, self-monitoring, and self-regulatory effort.

      Habits Mean of the four items. Frequencies with which critical situations were encountered
      and appropriate responses were used Total scores Qualitative study For the follow-up
      qualitative interview component (used specifically in phase 2), thematic analysis will be
      used to further explore the issues identified in the online questionnaire, and the
      experiences of using the Volitional Help Sheet (i.e. making "IF-THEN" plans) to reduce
      self-harm.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Non-suicidal self-harm
time frame: 6 months
description: 'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.
measure: Suicidal ideation
time frame: 6 months
description: 'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.
measure: suicide attempts
time frame: 6 months
description: 'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.
measure: Exposure to suicide and mental imagery about death
time frame: 6 months
description: Measured at baseline and follow-up using seven items adapted from those used in the literature previously (https://pubmed.ncbi.nlm.nih.gov/26247914/). Calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be calculated as a total score.
measure: Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)
time frame: 6 months
description: Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.
measure: Habit
time frame: 6 months
description: Measured using the self-reported habit index (automaticity scale; https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-9-102). This consists of four items (each from 1 to 7). Items are scored from 1 to 7, with a higher mean score indicating higher agreement with the statements.
measure: State self-regulation
time frame: 6 months
description: Items are adapted from those used previously (https://www.tandfonline.com/doi/abs/10.1080/08870440512331317670).
Mean of the two items for each of three sub-constructs: awareness of standards, self-monitoring, and self-regulatory effort. Items are scored from 1 to 7, with higher scores indicating higher agreement with the statements.
measure: Frequencies with which critical situations were encountered and appropriate responses were used
time frame: 6 months
description: Frequencies
arm group label: Control (volitional help sheet)
arm group type: Active Comparator
description: Participants read a brief statement designed to encourage them to be more physically active ("We want you to plan to increase your level of physical activity"). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted not to be physically active and identifying ways to overcome those temptations had been shown to help people change their behaviour.
Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.
arm group label: Intervention (volitional help sheet)
arm group type: Experimental
description: Participants read a brief statement designed to encourage them to avoid self-harming ("We want you to plan to avoid self-harming"). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour.
Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.
intervention type: Behavioral
intervention name: Volitional help sheet
description: Participants are asked to choose from a list of strategies for increasing physical activity
arm group label: Control (volitional help sheet)
intervention type: Behavioral
intervention name: Volitional help sheet
description: Participants are asked to choose from a list of strategies for avoiding self-harm
arm group label: Intervention (volitional help sheet)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
url: http://doc.ukdataservice.ac.uk/doc/6379/mrdoc/pdf/6379_apms_2007_research_report.pdf
description: Adult psychiatric morbidity in England, 2007
citation: O'Connor RC, Ferguson E, Scott F, Smyth R, McDaid D, Park AL, Beautrais A, Armitage CJ. A brief psychological intervention to reduce repetition of self-harm in patients admitted to hospital following a suicide attempt: a randomised controlled trial. Lancet Psychiatry. 2017 Jun;4(6):451-460. doi: 10.1016/S2215-0366(17)30129-3. Epub 2017 Apr 20.
PMID: 28434871
citation: Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.
PMID: 28126032
citation: Biddle L, Cooper J, Owen-Smith A, Klineberg E, Bennewith O, Hawton K, Kapur N, Donovan J, Gunnell D. Qualitative interviewing with vulnerable populations: individuals' experiences of participating in suicide and self-harm based research. J Affect Disord. 2013 Mar 5;145(3):356-62. doi: 10.1016/j.jad.2012.08.024. Epub 2012 Sep 25.
PMID: 23021191
citation: Dhingra K, Boduszek D, O'Connor RC. Differentiating suicide attempters from suicide ideators using the Integrated Motivational-Volitional model of suicidal behaviour. J Affect Disord. 2015 Nov 1;186:211-8. doi: 10.1016/j.jad.2015.07.007. Epub 2015 Jul 29.
PMID: 26247914
citation: O'Connor RC, Rasmussen S, Hawton K. Distinguishing adolescents who think about self-harm from those who engage in self-harm. Br J Psychiatry. 2012 Apr;200(4):330-5. doi: 10.1192/bjp.bp.111.097808. Epub 2012 Mar 8.
PMID: 22403089
citation: Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations ("COM-B"). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20.
PMID: 32314500
citation: Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.
PMID: 8778124
citation: Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.
PMID: 32226353
citation: Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
PMID: 12900694
citation: Vanaken L, Scheveneels S, Belmans E, Hermans D. Validation of the Impact of Event Scale With Modifications for COVID-19 (IES-COVID19). Front Psychiatry. 2020 Jul 28;11:738. doi: 10.3389/fpsyt.2020.00738. eCollection 2020.
PMID: 32848918
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Dr Chris Keyworth
investigator title: Research Fellow
mesh term: Self-Injurious Behavior