<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/NCT04463654</url>
  </required_header>
  <id_info>
    <org_study_id>213+983</org_study_id>
    <nct_id>NCT04463654</nct_id>
  </id_info>
  <brief_title>Zero Self-Harm - a Mobile Phone Application to Reduce Non-suicidal Self-injury</brief_title>
  <official_title>Zero Self-Harm - a Mobile Phone Application to Reduce Non-suicidal Self-injury: A Randomized Clinical Superiority Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mental Health Services in the Capital Region, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TrygFonden, Denmark</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mental Health Services in the Capital Region, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Non-suicidal self-injury (NSSI), the deliberate, self-inflicted destruction of body tissue&#xD;
      without suicidal intent and for purposes not socially sanctioned, is an increasing health&#xD;
      care problem in Denmark. Approximately 20 % of Danish adolescents report a history of NSSI at&#xD;
      some point in their lives. Individuals with NSSI have an increased risk of suicidality.&#xD;
      Therefore, it is of great importance to develop and investigate the effectiveness of a&#xD;
      low-cost app in reducing NSSI.&#xD;
&#xD;
      The purpose is to investigate whether treatment as usual (TAU) and the Zero Self-Harm app is&#xD;
      superior to TAU in reducing 1) frequency of NSSI-episodes and 2) suicide ideation, and&#xD;
      depressive symptoms in individuals with NSSI. As people with NSSI, without a comorbid&#xD;
      psychiatric diagnosis, are not eligible to receive psychiatric treatment in Denmark, TAU&#xD;
      includes many different treatments and counseling services, i.e. counseling at non-profit&#xD;
      organizations, service centers in the municipalities, outpatient treatment services for&#xD;
      psychiatric disorders, and care, information and attention at emergency departments. Common&#xD;
      to them all is that they do not offer specialized treatment focused on NSSI.&#xD;
&#xD;
      The trial is designed as a 2-arm, parallel group, 6 months, randomized clinical superiority&#xD;
      trial. A total of 280 participants, 140 in each arm, will be included. One group will receive&#xD;
      TAU, the other will receive TAU and the Zero Self-Harm App. Participants will be recruited&#xD;
      through non-profit organizations, service centers in the municipalities, outpatient treatment&#xD;
      services, and psychiatric and somatic emergency departments in Denmark.&#xD;
&#xD;
      Inclusion criteria are engagement in two or more episodes of NSSI in the past month, no&#xD;
      further planned treatment, have a smartphone, fluent in Danish, provide an informed written&#xD;
      consent, age above 18 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the trial is to investigate whether the introduction of the Zero Self-harm app&#xD;
      to individuals with NSSI in Denmark, can 1) reduce the frequency of NSSI-episodes, 2) prevent&#xD;
      escalation of NSSI and 3) reduce suicide ideation, and depressive symptoms, compared to&#xD;
      treatment as usual.&#xD;
&#xD;
      Hypothesis: The hypothesis is that Zero Self-Harm will reduce the frequency of NSSI-episodes&#xD;
      by enhancing participants skills to avoid impulsive urges resulting in NSSI. Thereby, the app&#xD;
      will help deal with negative affect and trait impulsivity, core features in the etiology of&#xD;
      NSSI, and further decrease associated symptoms, e.g. suicide ideation and depression. We&#xD;
      expect that the Zero Self-Harm app will be able to reduce the mean monthly frequency of NSSI&#xD;
      in the intervention group by at least 3 episodes. Thus, we hypothesize that the Zero&#xD;
      Self-Harm app will be superior to the control condition in 1) reducing the frequency of&#xD;
      NSSI-episodes, 2) preventing escalation of NSSI and 3) reducing suicide ideation, and&#xD;
      depressive symptoms, compared to treatment as usual.&#xD;
&#xD;
      Methods and design: The trial is designed as a 2-arm, parallel-group, multicentre, pragmatic,&#xD;
      randomized clinical superiority trial. Based on the power calculation listed below, a total&#xD;
      of 280 participants, 140 in each arm, should be included. One group will receive the Zero&#xD;
      Self-Harm app by downloading a specific link sent to them after randomization, and the&#xD;
      control group will be allocated to a wait-list and allowed to download the app after they&#xD;
      have finished the last questionnaire at 6 months.&#xD;
&#xD;
      Recruitment: Recruitment will be broad and target both individuals with shorter duration and&#xD;
      milder symptoms of NSSI, possibly not in contact with mental health facilities, and&#xD;
      individuals with more severe and chronic NSSI, already in contact with mental health&#xD;
      facilities in Denmark. Recruitment will be done through non-profit organizations, service&#xD;
      centres in municipalities, schools for adolescents above 18, outpatient clinics for&#xD;
      psychiatric disorders, and psychiatric and somatic emergency departments in Denmark.&#xD;
      Recruitment will be conducted through non-profit organizations' websites and social media&#xD;
      platforms, as well as providing information about the project through presentations at&#xD;
      schools, posters at relevant recruitment facilities and encouraging personnel to refer&#xD;
      potential participants when meeting people with NSSI.&#xD;
&#xD;
      Enrolment and randomization: Enrolment will be done by the research assistant when contacted&#xD;
      by potential participants via email or telephone. Participants will be encouraged not to send&#xD;
      personal information through email and only over the phone, to ensure confidentiality.&#xD;
      Potential participants will be given oral and written information about the study, time for&#xD;
      consideration and the possibility for an appointment with a next of kin before deciding to&#xD;
      enrol in the project. Consent will be obtained by sending an e-mail from REDCap to the&#xD;
      trusted Danish secure platform e-boks.&#xD;
&#xD;
      After filling out the baseline questionnaire, participants will be randomly assigned to&#xD;
      either the waitlist control group or the Zero Self-harm app, with a 1:1 allocation, using a&#xD;
      computer-generated sequence randomization generator in REDCap. The randomization will be&#xD;
      stratified by sex and number of previous NSSI-episodes (based on the baseline score of the&#xD;
      DSHI) to avoid overrepresentation of patients with a high number og NSSI in one treatment&#xD;
      group.&#xD;
&#xD;
      Blinding: Due to the nature of the intervention, neither participants nor the research&#xD;
      assistant can be blinded in this trial, and neither primary nor explorative outcomes can be&#xD;
      blinded. An employee outside the research team will extract data from REDCap at study&#xD;
      completion to two separate excel-sheets, and group allocation will be coded with A and B, to&#xD;
      ensure blinding of the research assistant while analysing data, drawing conclusions and&#xD;
      drafting the first manuscript. Blinding will be lifted once drafting of the first manuscript&#xD;
      has been done.&#xD;
&#xD;
      Intervention: When randomized to the Zero Self-Harm app the participants will receive an&#xD;
      email with a link to download the app and an introduction via an instruction manual, in&#xD;
      addition to instruction videos implemented in the app. This will ensure the navigation and&#xD;
      knowledge of the technicalities of the app. Participants in the waitlist control group will&#xD;
      receive no study intervention but will be offered the possibility to download the Zero&#xD;
      Self-Harm app after they have finished the last questionnaire at 6 months. This will be&#xD;
      stressed at the initial appointment as well as after the collection of data.&#xD;
&#xD;
      Data management: Above-mentioned outcome measures are collected at baseline and 3- and&#xD;
      6-month follow-up through self-administered internet-based questionnaires from REDCap.&#xD;
      Participants will receive an e-mail with a link to the online survey, where they can log on&#xD;
      to a secure data portal, REDCap, with a personal trial id-number and a two step-code. To&#xD;
      improve the response rate, two email reminders are sent out automatically, and if&#xD;
      participants still have not answered the questionnaire, they will receive a phone call from&#xD;
      the research assistant encouraging them to answer the questionnaire. When data collection is&#xD;
      finished, all data from the participants will be imported to a local secured drive with&#xD;
      limited access.&#xD;
&#xD;
      Further, there will be a continuous data collection with information about the usage of the&#xD;
      app, and register-based data will be collected through the Danish National Hospital Register&#xD;
      and the Cause of Death Register. App use and register-based outcomes, such as mortality and&#xD;
      admission to psychiatric and/or somatic emergency departments, will be assessed at 3 and 6&#xD;
      months.&#xD;
&#xD;
      To be aware of potential harms of the app, the 20 first participants receiving the Zero&#xD;
      Self-harm app will receive a call after they have completed the last questionnaire at&#xD;
      6-months, and interviewed about their experiences of the app. These interviews will be&#xD;
      analysed for possible harms, and the results will be discussed in the research group which&#xD;
      will then decide on whether or not to continue the trial.&#xD;
&#xD;
      Power analysis: Primary outcome is the mean difference in the monthly frequency of NSSI after&#xD;
      6 months. We expect that participants in the intervention group will have a mean score that&#xD;
      is 3.5 points lower compared to participants in the TAU group at follow-up after 6 months.&#xD;
      The mean score is based on clinical experience and estimates from a previous study&#xD;
      investigating the interventions ability to reduce monthly NSSI episodes (45). Based on&#xD;
      previous publications, we expect a post-intervention standard deviation of 9. If the true&#xD;
      difference in the experimental and control means is 3.5, we will need to include 140&#xD;
      participants for each group to a total of 280 participants to be able to reject the null&#xD;
      hypothesis, that the population means of the experimental and control groups are equal with a&#xD;
      probability of 0,1. The Type I error probability associated with this test is 0.05.&#xD;
&#xD;
      Statistical analysis: Analysis of the primary outcome will be conducted according to the&#xD;
      intention-to-treat principle: All participants will be included in the final analysis&#xD;
      according to group assignment regardless of adherence to treatment. This study has multiple&#xD;
      assessment points and for the primary analysis, we will use repeated measurements in a mixed&#xD;
      model with unstructured variance. This procedure can handle baseline differences and missing&#xD;
      data. For participants with missing data in two or more data points, we will identify&#xD;
      potential differences to participants with full data and include these variables as potential&#xD;
      confounders in secondary analysis .&#xD;
&#xD;
      Statistical analysis will be conducted in SPSS, version 22.0. Confidence intervals will be&#xD;
      presented as well as significance level. All tests will be two-tailed and p values below 0.5&#xD;
      will be considered significant and interpreted with respect to hierarchy of hypothesis&#xD;
      recognizing that all outcomes, apart from the primary, are exploratory .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 15, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Deliberate Self Harm Inventory</measure>
    <time_frame>6 month</time_frame>
    <description>17-item self-report questionnaire that assesses various aspects of self harm (defined as the deliberate, direct self-destruction of body tissue without suicidal intent) over specified time periods, including frequency (continuous range) and type of self-harm behavior (e.g. cutting, burning etc.). The DSHI demonstrates adequate test-retest reliability and construct, discriminant validity among non-clinical and patient samples</description>
  </primary_outcome>
  <other_outcome>
    <measure>Becks Suicide Ideation Scale</measure>
    <time_frame>6 month</time_frame>
    <description>Becks Suicide Ideation Scale is a 21-item self-report questionnaire measuring suicidal thinking. The outcome is considered as a proxy measure for suicide attempt.</description>
  </other_outcome>
  <other_outcome>
    <measure>Major Depression Inventory (MDI)</measure>
    <time_frame>6 month</time_frame>
    <description>The Major Depression Inventory is a short questionnaire consisting of 12 items capturing depressive symptoms. It can be scored as a diagnostic tool, but also according to severity by a simple sum of the item scores. The minimum score is 0 which indicates no depression and the maximum value is 65 which indicates severe depression.</description>
  </other_outcome>
  <other_outcome>
    <measure>WHO Well-being Index</measure>
    <time_frame>6 month</time_frame>
    <description>The WHO Well-being Index (WHO-5), a widely used short questionnaire to measure quality of life, consisting of 5 simple and non-invasive questions. It is among the most widely used questionnaires assessing subjective psychological well-being.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rosenberg's Self-Esteem scale</measure>
    <time_frame>6 month</time_frame>
    <description>The Rosenberg's Self-Esteem scale consists of 10 items and is a Likert scale. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Self-Injurious Behavior</condition>
  <arm_group>
    <arm_group_label>Zero Self-Harm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>When randomized to the Zero Self-Harm app the participants will receive an introduction to the app through videos in the app, which explains, amongst others, how to review previous crisis situations and possible strategies for future crisis. This will ensure the navigation and knowledge of the technicalities of the app, in addition to ensure the app can be used privately without personal guidance from e.g a therapist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will continue their present course of treatment and/or counseling at non-profit organizations, service centers in the municipalities, at outpatient treatment services for psychiatric disorders and/or care, attention at emergency departments. They will receive no treatment on the nature of NSSI. Participants in the control group will be offered a possibility to download the Zero Self-Harm app after they have completed the last questionnaire at six months, which will be stressed at the initial appointment as well as after collection of all data.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zero Self-Harm app</intervention_name>
    <description>Safety plan app for smartphones</description>
    <arm_group_label>Zero Self-Harm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Engagement in two or more episodes of NSSI in the past month.&#xD;
&#xD;
          -  No further planned treatment focused on NSSI.&#xD;
&#xD;
          -  Have a smartphone (IPhone or Android phone).&#xD;
&#xD;
          -  Fluent in Danish.&#xD;
&#xD;
          -  Skills sufficient to enable use of the Zero Self-Harm app.&#xD;
&#xD;
          -  Provide an informed written consent.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of informed consent.&#xD;
&#xD;
          -  Forced care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Merete Nordentoft, MD, Ph.D MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Mental Health Center Copenhagen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lene Qvist Larsen, Cand.scient</last_name>
    <phone>+45 29 34 94 25</phone>
    <email>lene.qvist.larsen.01@regionh.dk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kate Aamund, Ph.D.</last_name>
    <email>kate.aamund@regionh.dk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Region Hovedstaden</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lene Larsen, Phd student</last_name>
      <phone>29 34 94 25</phone>
      <email>lenelarsen0@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Self-Injurious Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463654
org study id: 213+983
nct id: NCT04463654
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Non-suicidal self-injury (NSSI), the deliberate, self-inflicted destruction of body tissue
      without suicidal intent and for purposes not socially sanctioned, is an increasing health
      care problem in Denmark. Approximately 20 % of Danish adolescents report a history of NSSI at
      some point in their lives. Individuals with NSSI have an increased risk of suicidality.
      Therefore, it is of great importance to develop and investigate the effectiveness of a
      low-cost app in reducing NSSI.

      The purpose is to investigate whether treatment as usual (TAU) and the Zero Self-Harm app is
      superior to TAU in reducing 1) frequency of NSSI-episodes and 2) suicide ideation, and
      depressive symptoms in individuals with NSSI. As people with NSSI, without a comorbid
      psychiatric diagnosis, are not eligible to receive psychiatric treatment in Denmark, TAU
      includes many different treatments and counseling services, i.e. counseling at non-profit
      organizations, service centers in the municipalities, outpatient treatment services for
      psychiatric disorders, and care, information and attention at emergency departments. Common
      to them all is that they do not offer specialized treatment focused on NSSI.

      The trial is designed as a 2-arm, parallel group, 6 months, randomized clinical superiority
      trial. A total of 280 participants, 140 in each arm, will be included. One group will receive
      TAU, the other will receive TAU and the Zero Self-Harm App. Participants will be recruited
      through non-profit organizations, service centers in the municipalities, outpatient treatment
      services, and psychiatric and somatic emergency departments in Denmark.

      Inclusion criteria are engagement in two or more episodes of NSSI in the past month, no
      further planned treatment, have a smartphone, fluent in Danish, provide an informed written
      consent, age above 18 years.
The purpose of the trial is to investigate whether the introduction of the Zero Self-harm app
      to individuals with NSSI in Denmark, can 1) reduce the frequency of NSSI-episodes, 2) prevent
      escalation of NSSI and 3) reduce suicide ideation, and depressive symptoms, compared to
      treatment as usual.

      Hypothesis: The hypothesis is that Zero Self-Harm will reduce the frequency of NSSI-episodes
      by enhancing participants skills to avoid impulsive urges resulting in NSSI. Thereby, the app
      will help deal with negative affect and trait impulsivity, core features in the etiology of
      NSSI, and further decrease associated symptoms, e.g. suicide ideation and depression. We
      expect that the Zero Self-Harm app will be able to reduce the mean monthly frequency of NSSI
      in the intervention group by at least 3 episodes. Thus, we hypothesize that the Zero
      Self-Harm app will be superior to the control condition in 1) reducing the frequency of
      NSSI-episodes, 2) preventing escalation of NSSI and 3) reducing suicide ideation, and
      depressive symptoms, compared to treatment as usual.

      Methods and design: The trial is designed as a 2-arm, parallel-group, multicentre, pragmatic,
      randomized clinical superiority trial. Based on the power calculation listed below, a total
      of 280 participants, 140 in each arm, should be included. One group will receive the Zero
      Self-Harm app by downloading a specific link sent to them after randomization, and the
      control group will be allocated to a wait-list and allowed to download the app after they
      have finished the last questionnaire at 6 months.

      Recruitment: Recruitment will be broad and target both individuals with shorter duration and
      milder symptoms of NSSI, possibly not in contact with mental health facilities, and
      individuals with more severe and chronic NSSI, already in contact with mental health
      facilities in Denmark. Recruitment will be done through non-profit organizations, service
      centres in municipalities, schools for adolescents above 18, outpatient clinics for
      psychiatric disorders, and psychiatric and somatic emergency departments in Denmark.
      Recruitment will be conducted through non-profit organizations' websites and social media
      platforms, as well as providing information about the project through presentations at
      schools, posters at relevant recruitment facilities and encouraging personnel to refer
      potential participants when meeting people with NSSI.

      Enrolment and randomization: Enrolment will be done by the research assistant when contacted
      by potential participants via email or telephone. Participants will be encouraged not to send
      personal information through email and only over the phone, to ensure confidentiality.
      Potential participants will be given oral and written information about the study, time for
      consideration and the possibility for an appointment with a next of kin before deciding to
      enrol in the project. Consent will be obtained by sending an e-mail from REDCap to the
      trusted Danish secure platform e-boks.

      After filling out the baseline questionnaire, participants will be randomly assigned to
      either the waitlist control group or the Zero Self-harm app, with a 1:1 allocation, using a
      computer-generated sequence randomization generator in REDCap. The randomization will be
      stratified by sex and number of previous NSSI-episodes (based on the baseline score of the
      DSHI) to avoid overrepresentation of patients with a high number og NSSI in one treatment
      group.

      Blinding: Due to the nature of the intervention, neither participants nor the research
      assistant can be blinded in this trial, and neither primary nor explorative outcomes can be
      blinded. An employee outside the research team will extract data from REDCap at study
      completion to two separate excel-sheets, and group allocation will be coded with A and B, to
      ensure blinding of the research assistant while analysing data, drawing conclusions and
      drafting the first manuscript. Blinding will be lifted once drafting of the first manuscript
      has been done.

      Intervention: When randomized to the Zero Self-Harm app the participants will receive an
      email with a link to download the app and an introduction via an instruction manual, in
      addition to instruction videos implemented in the app. This will ensure the navigation and
      knowledge of the technicalities of the app. Participants in the waitlist control group will
      receive no study intervention but will be offered the possibility to download the Zero
      Self-Harm app after they have finished the last questionnaire at 6 months. This will be
      stressed at the initial appointment as well as after the collection of data.

      Data management: Above-mentioned outcome measures are collected at baseline and 3- and
      6-month follow-up through self-administered internet-based questionnaires from REDCap.
      Participants will receive an e-mail with a link to the online survey, where they can log on
      to a secure data portal, REDCap, with a personal trial id-number and a two step-code. To
      improve the response rate, two email reminders are sent out automatically, and if
      participants still have not answered the questionnaire, they will receive a phone call from
      the research assistant encouraging them to answer the questionnaire. When data collection is
      finished, all data from the participants will be imported to a local secured drive with
      limited access.

      Further, there will be a continuous data collection with information about the usage of the
      app, and register-based data will be collected through the Danish National Hospital Register
      and the Cause of Death Register. App use and register-based outcomes, such as mortality and
      admission to psychiatric and/or somatic emergency departments, will be assessed at 3 and 6
      months.

      To be aware of potential harms of the app, the 20 first participants receiving the Zero
      Self-harm app will receive a call after they have completed the last questionnaire at
      6-months, and interviewed about their experiences of the app. These interviews will be
      analysed for possible harms, and the results will be discussed in the research group which
      will then decide on whether or not to continue the trial.

      Power analysis: Primary outcome is the mean difference in the monthly frequency of NSSI after
      6 months. We expect that participants in the intervention group will have a mean score that
      is 3.5 points lower compared to participants in the TAU group at follow-up after 6 months.
      The mean score is based on clinical experience and estimates from a previous study
      investigating the interventions ability to reduce monthly NSSI episodes (45). Based on
      previous publications, we expect a post-intervention standard deviation of 9. If the true
      difference in the experimental and control means is 3.5, we will need to include 140
      participants for each group to a total of 280 participants to be able to reject the null
      hypothesis, that the population means of the experimental and control groups are equal with a
      probability of 0,1. The Type I error probability associated with this test is 0.05.

      Statistical analysis: Analysis of the primary outcome will be conducted according to the
      intention-to-treat principle: All participants will be included in the final analysis
      according to group assignment regardless of adherence to treatment. This study has multiple
      assessment points and for the primary analysis, we will use repeated measurements in a mixed
      model with unstructured variance. This procedure can handle baseline differences and missing
      data. For participants with missing data in two or more data points, we will identify
      potential differences to participants with full data and include these variables as potential
      confounders in secondary analysis .

      Statistical analysis will be conducted in SPSS, version 22.0. Confidence intervals will be
      presented as well as significance level. All tests will be two-tailed and p values below 0.5
      will be considered significant and interpreted with respect to hierarchy of hypothesis
      recognizing that all outcomes, apart from the primary, are exploratory .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Deliberate Self Harm Inventory
time frame: 6 month
description: 17-item self-report questionnaire that assesses various aspects of self harm (defined as the deliberate, direct self-destruction of body tissue without suicidal intent) over specified time periods, including frequency (continuous range) and type of self-harm behavior (e.g. cutting, burning etc.). The DSHI demonstrates adequate test-retest reliability and construct, discriminant validity among non-clinical and patient samples
measure: Becks Suicide Ideation Scale
time frame: 6 month
description: Becks Suicide Ideation Scale is a 21-item self-report questionnaire measuring suicidal thinking. The outcome is considered as a proxy measure for suicide attempt.
measure: Major Depression Inventory (MDI)
time frame: 6 month
description: The Major Depression Inventory is a short questionnaire consisting of 12 items capturing depressive symptoms. It can be scored as a diagnostic tool, but also according to severity by a simple sum of the item scores. The minimum score is 0 which indicates no depression and the maximum value is 65 which indicates severe depression.
measure: WHO Well-being Index
time frame: 6 month
description: The WHO Well-being Index (WHO-5), a widely used short questionnaire to measure quality of life, consisting of 5 simple and non-invasive questions. It is among the most widely used questionnaires assessing subjective psychological well-being.
measure: Rosenberg's Self-Esteem scale
time frame: 6 month
description: The Rosenberg's Self-Esteem scale consists of 10 items and is a Likert scale. The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
arm group label: Zero Self-Harm
arm group type: Experimental
description: When randomized to the Zero Self-Harm app the participants will receive an introduction to the app through videos in the app, which explains, amongst others, how to review previous crisis situations and possible strategies for future crisis. This will ensure the navigation and knowledge of the technicalities of the app, in addition to ensure the app can be used privately without personal guidance from e.g a therapist.
arm group label: Treatment as usual
arm group type: No Intervention
description: The control group will continue their present course of treatment and/or counseling at non-profit organizations, service centers in the municipalities, at outpatient treatment services for psychiatric disorders and/or care, attention at emergency departments. They will receive no treatment on the nature of NSSI. Participants in the control group will be offered a possibility to download the Zero Self-Harm app after they have completed the last questionnaire at six months, which will be stressed at the initial appointment as well as after collection of all data.
intervention type: Device
intervention name: Zero Self-Harm app
description: Safety plan app for smartphones
arm group label: Zero Self-Harm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Merete Nordentoft, MD, Ph.D MSc
role: Study Chair
affiliation: Mental Health Center Copenhagen
last name: Lene Qvist Larsen, Cand.scient
phone: +45 29 34 94 25
email: lene.qvist.larsen.01@regionh.dk
last name: Kate Aamund, Ph.D.
email: kate.aamund@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Sponsor
mesh term: Self-Injurious Behavior
sharing ipd: No