<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/NCT03271645</url>
  </required_header>
  <id_info>
    <org_study_id>iCBT@Work</org_study_id>
    <nct_id>NCT03271645</nct_id>
  </id_info>
  <brief_title>Internet-delivered Interventions for Stress, Anxiety and Depression in the Workplace</brief_title>
  <acronym>iCBT@Work</acronym>
  <official_title>Internet-delivered Interventions for Stress, Anxiety and Depression in the Workplace</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silver Cloud Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Silver Cloud Health</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>
      The research will utilise an open feasibility parallel groups trial to examine the impact of&#xD;
      novel internet-delivered cognitive behavioural therapy (CBT) interventions for stress,&#xD;
      anxiety, and depression compared to treatment as usual (face to face counselling and&#xD;
      psychotherapy) in an employment context. Participants will consist of employees accessing&#xD;
      services provided by employee assistance programmes (EAP) provided at the European&#xD;
      headquarters of a large technology organisation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be recruited for the online intervention through either self-referral or a&#xD;
      referral from one of the counsellors or GPs at the onsite well-being service centre.&#xD;
      Participants in the face-to-face group will be recruited by referral from a member of the&#xD;
      EAP; those on the waiting list for face-to-face services provided by the EAP will be&#xD;
      approached to participate in the research. At baseline, participants in both the online and&#xD;
      the face-to-face groups will complete sociodemographic information, the PHQ-4, PSS-4, the&#xD;
      HPQ-SF, as well as an assessment of risk using question 9 from the PHQ-9. Eligible&#xD;
      participants in the online intervention group will be offered one of three internet-delivered&#xD;
      CBT interventions (Space from Stress, Space from Anxiety, Space from Depression).&#xD;
      Participants attending the onsite EAP counselling service will receive 8 sessions of&#xD;
      counselling.&#xD;
&#xD;
      Risk Assessment&#xD;
&#xD;
      Participants will be screened at baseline for risk. This assessment will be conducted through&#xD;
      the response to question 9 on the PHQ-9, in which respondents are requested to indicate how&#xD;
      often they have been bothered by &quot;thoughts that you would be better off dead or of harming&#xD;
      yourself in some way&quot; rated on a 4-point Likert scale, with 0 indicated &quot;not at all&quot;, 1 =&#xD;
      &quot;several days&quot;, 2 = &quot;more than half the days&quot;, 3 = &quot;nearly every day&quot;. Any participant who&#xD;
      scores &gt; 1 will be automatically prompted to answer additional questions to qualify the level&#xD;
      of risk indicated. These questions include &quot;Do you have any current plans to end your life?&quot;,&#xD;
      &quot;Have you made any actual preparations towards ending your life?&quot; answered in a simple&#xD;
      &quot;yes/no&quot; format and &quot;how likely is it that you will act on these thoughts or plans to end&#xD;
      your life&quot; rated on a 0=10 scale with 0 indicating &quot;I would never do this&quot; and 10 indicating&#xD;
      &quot;I am definitely going to do this&quot;. Participants are also asked an open-ended question about&#xD;
      their protective factors &quot;what is stopping you from acting on these thoughts?&quot;. If any risk&#xD;
      to self or others is highlighted, the participant will be immediately provided with crisis&#xD;
      contact numbers (GP Out of Hours, Samaritans, Aware, Pieta House, Women's Aid, Amen) through&#xD;
      the platform, and encouraged to contact these services directly if they feel in crisis. In&#xD;
      addition, participants who indicate risk at baseline will be recommended that they contact&#xD;
      the onsite GP or one of the counsellors at the onsite wellness centre. Those who exceed the&#xD;
      cut-off score for risk ( &gt;1 PHQ-9 Question 9) on the screening questions will not be eligible&#xD;
      to participate in the study and will be able to access support from the onsite GP and /or the&#xD;
      counselling team at the onsite wellness centre.&#xD;
&#xD;
      During the course of the trial, all supporters who are trained mental health practitioners&#xD;
      will remain alert for indications of risk and will escalate concerns within the established&#xD;
      supervision governance structure in an appropriate time frame.&#xD;
&#xD;
      During treatment, participants in both the online interventions and the face-to-face&#xD;
      intervention will complete the PHQ-4 and PSS-4. At the end of the treatment, participants&#xD;
      will be asked to complete the PHQ-4, PSS-4, SAT, and the HPQ-SF. These measures will also be&#xD;
      completed at 4-months follow-up. A mixed-method approach will be used to include quantitative&#xD;
      and qualitative analysis of symptom severity, work performance, and user satisfaction.&#xD;
&#xD;
      Each of the online interventions (Space from Depression, Space from Anxiety, Space from&#xD;
      Stress) consists of 8 modules of internet-delivered CBT, delivered over an 8-week period.&#xD;
      Participants will be assigned a supporter who will provide weekly post-session feedback on&#xD;
      progress and exercises.&#xD;
&#xD;
      Support for this trial will be provided by Nuffield Health clinical support services.&#xD;
      Nuffield Clinical Support Services is an established clinical service that provides support&#xD;
      through Nuffield Health's Employee Assistance Programmes. The service is composed of British&#xD;
      Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited cognitive&#xD;
      behavioural psychotherapists. They also have a small group of psychological well-being&#xD;
      practitioners who are also British Association of Behavioural and Cognitive Psychotherapists&#xD;
      (BABCP) accredited or currently in supervised training for accreditation. Each supporter will&#xD;
      provide post-session feedback of between 10 and 15 minutes per participant per session.&#xD;
&#xD;
      Schedule of Assessment:&#xD;
&#xD;
      Participants will complete the primary and secondary outcome measures at baseline.&#xD;
      Thereafter, they will complete the PHQ-4 and PSS-4 at each counselling or online review&#xD;
      session. Once participants have completed treatment, they will be contacted to complete both&#xD;
      the primary and secondary outcome measures. Satisfaction with treatment will be measured&#xD;
      post-treatment at 4-month follow-up, where participants will complete the PHQ-4, PSS-4 and&#xD;
      HPQ-SF.&#xD;
&#xD;
      Data analysis:&#xD;
&#xD;
      The feasibility of Internet-delivered interventions for stress, anxiety and depression as&#xD;
      part of the organization's EAP will be evaluated based on participant recruitment, enrollment&#xD;
      and retention rates.&#xD;
&#xD;
      Effectiveness over time of Internet-delivered interventions for the treatment of stress,&#xD;
      anxiety and depression will be determined independently using linear mixed models. Stress&#xD;
      severity will be measured using PSS-4 scores, depression and anxiety severity using PHQ-4&#xD;
      scores. In addition, sociodemographic characteristics will be assessed at baseline and&#xD;
      factors significantly associated with treatment groups incorporated in the analysis model if&#xD;
      required.&#xD;
&#xD;
      The impact of an internet-delivered intervention on workplace absence and job performance&#xD;
      will be determined through the collection of HPQ-SF measures pre-treatment, immediately&#xD;
      post-treatment and at 4-month follow-up. HPQ-SF absenteeism and presenteeism scores will be&#xD;
      analysed using repeated measures ANOVA to detect differences at each time point.&#xD;
&#xD;
      Employee satisfaction with an internet-delivered intervention will be assessed in the&#xD;
      Satisfaction with Treatment Questionnaire. Quantitative and qualitative measures of&#xD;
      satisfaction will be summarised using descriptive statistics.&#xD;
&#xD;
      Internet-delivered intervention group:&#xD;
&#xD;
      Registered employees of the company will be eligible to participate in this study and will be&#xD;
      recruited through the services their EAP provide. Participants may also be referred to the&#xD;
      internet-delivered intervention by their general practitioner or other mental health&#xD;
      professionals within the EAP. Interested participants will be able to log on to the&#xD;
      SilverCloud Platform, where they can read the participant information sheet. Participants in&#xD;
      the face-to-face group will be given a hard copy of the participant information sheet. This&#xD;
      will detail what is involved with the study, the procedure, and how to proceed. Should&#xD;
      participants agree to take part in the research, they will be requested to indicate their&#xD;
      informed consent digitally. Participants will then complete the baseline measures.&#xD;
      Participants excluded at this stage based on their risk assessment scores will be directed to&#xD;
      the appropriate services within the EAP, for example, to the GP or face-to-face counselling&#xD;
      services.&#xD;
&#xD;
      Using computer algorithms to score screening instruments at baseline, participants will be&#xD;
      automatically provided with feedback on their measures (e.g. your scores indicate you may be&#xD;
      experiencing moderate symptoms of depression). This feedback consists of informing the&#xD;
      participant of their overall score for each measure and highlight the individual as the&#xD;
      expert in their own life. All participants in the Internet-delivered intervention group will&#xD;
      make an informed decision on choosing one of the three programmes, based on the combination&#xD;
      of scores from the depression, anxiety, and stress scales. Participants will then self-select&#xD;
      one of the three programmes: Space from Depression, Space from Anxiety, Space from Stress.&#xD;
&#xD;
      Each participant in the Internet-delivered intervention group will be assigned a supporter&#xD;
      who will monitor participant's progress throughout the trial. Once a participant begins their&#xD;
      chosen programme, they will receive a message from their supporter at their first log-in.&#xD;
      This message welcomes them to the programme, highlights aspects of it and encourages them in&#xD;
      the use of it. Weekly, supporters will log in and review participants progress, leaving&#xD;
      feedback for them and responding to the work they have completed. Supporters will be BABCP&#xD;
      accredited cognitive behavioural psychotherapists and psychological well-being practitioners&#xD;
      who are also BABCP accredited or currently in supervised training for accreditation, provided&#xD;
      by Nuffield Health EAP clinical support services. Each supporter will provide post-session&#xD;
      feedback of between 10 and 15 minutes per participant per session.&#xD;
&#xD;
      Face to face counselling/psychotherapy group:&#xD;
&#xD;
      Once the trial starts, those beginning face-to-face services will be approached to&#xD;
      participate in the research by a member of the EAP. Those who wish to participate will then&#xD;
      sign a paper/ digital on iPad consent form and will complete measures at baseline and&#xD;
      post-treatment, as per the schedule of assessment. Risk will be monitored by the clinician&#xD;
      responsible for the participant.&#xD;
&#xD;
      The study is an open feasibility trial that uses standard instruments to assess symptoms of&#xD;
      anxiety, depression and stress and adjustment psychopathology. It does this using reliable&#xD;
      and valid instruments, including:&#xD;
&#xD;
      Patient Health Questionnaire (PHQ-4) a self-report measure of depression and anxiety that has&#xD;
      been widely used in screening, primary care, and research. The PHQ-4 items reflect the&#xD;
      diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of&#xD;
      Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR).&#xD;
&#xD;
      Perceived Stress Scale (PSS-4): a self-report measure of non-specific perceived stress. Based&#xD;
      on Lazarus's transactional model of stress respondents rate how unpredictable,&#xD;
      uncontrollable, and overloaded they appraise their life to be. Items are answered on a&#xD;
      5-point Likert scale (0= never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often)&#xD;
      referring to the past month.&#xD;
&#xD;
      Health and Work Performance Questionnaire - Short Form: a brief self-report measure designed&#xD;
      to estimate the workplace costs of health difficulties in two domains: absenteeism and&#xD;
      reduced job performance. Validation studies have demonstrated significant correlations&#xD;
      between self-reported HPQ scores and archival pay roll and performance assessments. The HPQ&#xD;
      has been demonstrated to be valid, reliable and sensitive to change and recommended for use&#xD;
      in Internet-delivered environments.&#xD;
&#xD;
      Satisfaction with Treatment (SAT) Questionnaire: includes nine quantitative items rated on a&#xD;
      scale from 0 to 4 (e.g., How did this online treatment compare to previous treatments? 0 =&#xD;
      'Much better' to 4 = 'Not at all good'). The Satisfaction with Treatment questionnaire also&#xD;
      contains two qualitative questions asking participants to describe what they liked most and&#xD;
      least about the Internet-delivered intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    logistics&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 11, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PHQ-4</measure>
    <time_frame>Up to 4-months</time_frame>
    <description>Patient health Questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PSS-4</measure>
    <time_frame>Up to 4-months</time_frame>
    <description>Perceived Stress Scale-4 (PSS-4)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Health and Work Performance Questionnaire (HPQ-SF)</measure>
    <time_frame>Up to 4-months</time_frame>
    <description>Health and Work Performance Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Treatment Questionnaire (SAT)</measure>
    <time_frame>8 weeks</time_frame>
    <description>Satisfaction with Treatment Questionnaire (SAT)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Space from depression</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Space from depression is an 8 module CBT-based intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Space from Anxiety</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Space from anxiety CBT is an 8 module CBT-based intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Space from stress</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Space from stress CBT is an 8 module CBT-based intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Face-to-face counselling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Face-to-face counselling</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Space from Depression</intervention_name>
    <description>The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.</description>
    <arm_group_label>Space from depression</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Space from Anxiety</intervention_name>
    <description>The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.</description>
    <arm_group_label>Space from Anxiety</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Space from Stress</intervention_name>
    <description>The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014).The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.</description>
    <arm_group_label>Space from stress</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Face-to-face counselling</intervention_name>
    <description>Face-to-face counselling</description>
    <arm_group_label>Face-to-face counselling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants will be 18+ years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Suicidal intent/ideation: score &gt;1 on PHQ-9 question 9.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek Richards, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>SilverCloud Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Multinational Technology Industry European HQ</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <link>
    <url>http://www.silvercloudhealth.com</url>
    <description>SilverCloud website</description>
  </link>
  <reference>
    <citation>Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.</citation>
    <PMID>11556941</PMID>
  </reference>
  <reference>
    <citation>American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th ed. Washington D.C.: American Psychiatric Association.; 2000.</citation>
  </reference>
  <reference>
    <citation>Cohen S, Williamson G. Perceived stress in a probability sample of the United States. In: S. Spacapan, Oskamp S, editors. The social psychology of health. Newbury Park, CA: Sage; 1988.</citation>
  </reference>
  <reference>
    <citation>Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.</citation>
    <PMID>6668417</PMID>
  </reference>
  <reference>
    <citation>Kessler R, Petukhova M, McInnes K. World Health Organization Health and Work Performance Questionnaire (HPQ). HPQ Short Form (Absenteeism and Presenteeism Questions and Scoring Rules) Harvard Medical School. 2007.</citation>
  </reference>
  <reference>
    <citation>Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51.</citation>
    <PMID>12625231</PMID>
  </reference>
  <reference>
    <citation>Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling DE, Stang PE, Ustun TB. Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004 Jun;46(6 Suppl):S23-37. doi: 10.1097/01.jom.0000126683.75201.c5.</citation>
    <PMID>15194893</PMID>
  </reference>
  <reference>
    <citation>Richards D, Timulak L. Satisfaction with therapist-delivered vs. self-administered online cognitive-behavioural treatments for depression symptoms in college students. British Journal of Guidance &amp; Counselling. 2012;41(2):193-207</citation>
  </reference>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Depression</keyword>
  <keyword>Anxiety</keyword>
  <keyword>Stress</keyword>
  <keyword>Internet-delivered interventions</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03271645
org study id: iCBT@Work
nct id: NCT03271645
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The research will utilise an open feasibility parallel groups trial to examine the impact of
      novel internet-delivered cognitive behavioural therapy (CBT) interventions for stress,
      anxiety, and depression compared to treatment as usual (face to face counselling and
      psychotherapy) in an employment context. Participants will consist of employees accessing
      services provided by employee assistance programmes (EAP) provided at the European
      headquarters of a large technology organisation.
Participants will be recruited for the online intervention through either self-referral or a
      referral from one of the counsellors or GPs at the onsite well-being service centre.
      Participants in the face-to-face group will be recruited by referral from a member of the
      EAP; those on the waiting list for face-to-face services provided by the EAP will be
      approached to participate in the research. At baseline, participants in both the online and
      the face-to-face groups will complete sociodemographic information, the PHQ-4, PSS-4, the
      HPQ-SF, as well as an assessment of risk using question 9 from the PHQ-9. Eligible
      participants in the online intervention group will be offered one of three internet-delivered
      CBT interventions (Space from Stress, Space from Anxiety, Space from Depression).
      Participants attending the onsite EAP counselling service will receive 8 sessions of
      counselling.

      Risk Assessment

      Participants will be screened at baseline for risk. This assessment will be conducted through
      the response to question 9 on the PHQ-9, in which respondents are requested to indicate how
      often they have been bothered by "thoughts that you would be better off dead or of harming
      yourself in some way" rated on a 4-point Likert scale, with 0 indicated "not at all", 1 =
      "several days", 2 = "more than half the days", 3 = "nearly every day". Any participant who
      scores > 1 will be automatically prompted to answer additional questions to qualify the level
      of risk indicated. These questions include "Do you have any current plans to end your life?",
      "Have you made any actual preparations towards ending your life?" answered in a simple
      "yes/no" format and "how likely is it that you will act on these thoughts or plans to end
      your life" rated on a 0=10 scale with 0 indicating "I would never do this" and 10 indicating
      "I am definitely going to do this". Participants are also asked an open-ended question about
      their protective factors "what is stopping you from acting on these thoughts?". If any risk
      to self or others is highlighted, the participant will be immediately provided with crisis
      contact numbers (GP Out of Hours, Samaritans, Aware, Pieta House, Women's Aid, Amen) through
      the platform, and encouraged to contact these services directly if they feel in crisis. In
      addition, participants who indicate risk at baseline will be recommended that they contact
      the onsite GP or one of the counsellors at the onsite wellness centre. Those who exceed the
      cut-off score for risk ( >1 PHQ-9 Question 9) on the screening questions will not be eligible
      to participate in the study and will be able to access support from the onsite GP and /or the
      counselling team at the onsite wellness centre.

      During the course of the trial, all supporters who are trained mental health practitioners
      will remain alert for indications of risk and will escalate concerns within the established
      supervision governance structure in an appropriate time frame.

      During treatment, participants in both the online interventions and the face-to-face
      intervention will complete the PHQ-4 and PSS-4. At the end of the treatment, participants
      will be asked to complete the PHQ-4, PSS-4, SAT, and the HPQ-SF. These measures will also be
      completed at 4-months follow-up. A mixed-method approach will be used to include quantitative
      and qualitative analysis of symptom severity, work performance, and user satisfaction.

      Each of the online interventions (Space from Depression, Space from Anxiety, Space from
      Stress) consists of 8 modules of internet-delivered CBT, delivered over an 8-week period.
      Participants will be assigned a supporter who will provide weekly post-session feedback on
      progress and exercises.

      Support for this trial will be provided by Nuffield Health clinical support services.
      Nuffield Clinical Support Services is an established clinical service that provides support
      through Nuffield Health's Employee Assistance Programmes. The service is composed of British
      Association of Behavioural and Cognitive Psychotherapists (BABCP) accredited cognitive
      behavioural psychotherapists. They also have a small group of psychological well-being
      practitioners who are also British Association of Behavioural and Cognitive Psychotherapists
      (BABCP) accredited or currently in supervised training for accreditation. Each supporter will
      provide post-session feedback of between 10 and 15 minutes per participant per session.

      Schedule of Assessment:

      Participants will complete the primary and secondary outcome measures at baseline.
      Thereafter, they will complete the PHQ-4 and PSS-4 at each counselling or online review
      session. Once participants have completed treatment, they will be contacted to complete both
      the primary and secondary outcome measures. Satisfaction with treatment will be measured
      post-treatment at 4-month follow-up, where participants will complete the PHQ-4, PSS-4 and
      HPQ-SF.

      Data analysis:

      The feasibility of Internet-delivered interventions for stress, anxiety and depression as
      part of the organization's EAP will be evaluated based on participant recruitment, enrollment
      and retention rates.

      Effectiveness over time of Internet-delivered interventions for the treatment of stress,
      anxiety and depression will be determined independently using linear mixed models. Stress
      severity will be measured using PSS-4 scores, depression and anxiety severity using PHQ-4
      scores. In addition, sociodemographic characteristics will be assessed at baseline and
      factors significantly associated with treatment groups incorporated in the analysis model if
      required.

      The impact of an internet-delivered intervention on workplace absence and job performance
      will be determined through the collection of HPQ-SF measures pre-treatment, immediately
      post-treatment and at 4-month follow-up. HPQ-SF absenteeism and presenteeism scores will be
      analysed using repeated measures ANOVA to detect differences at each time point.

      Employee satisfaction with an internet-delivered intervention will be assessed in the
      Satisfaction with Treatment Questionnaire. Quantitative and qualitative measures of
      satisfaction will be summarised using descriptive statistics.

      Internet-delivered intervention group:

      Registered employees of the company will be eligible to participate in this study and will be
      recruited through the services their EAP provide. Participants may also be referred to the
      internet-delivered intervention by their general practitioner or other mental health
      professionals within the EAP. Interested participants will be able to log on to the
      SilverCloud Platform, where they can read the participant information sheet. Participants in
      the face-to-face group will be given a hard copy of the participant information sheet. This
      will detail what is involved with the study, the procedure, and how to proceed. Should
      participants agree to take part in the research, they will be requested to indicate their
      informed consent digitally. Participants will then complete the baseline measures.
      Participants excluded at this stage based on their risk assessment scores will be directed to
      the appropriate services within the EAP, for example, to the GP or face-to-face counselling
      services.

      Using computer algorithms to score screening instruments at baseline, participants will be
      automatically provided with feedback on their measures (e.g. your scores indicate you may be
      experiencing moderate symptoms of depression). This feedback consists of informing the
      participant of their overall score for each measure and highlight the individual as the
      expert in their own life. All participants in the Internet-delivered intervention group will
      make an informed decision on choosing one of the three programmes, based on the combination
      of scores from the depression, anxiety, and stress scales. Participants will then self-select
      one of the three programmes: Space from Depression, Space from Anxiety, Space from Stress.

      Each participant in the Internet-delivered intervention group will be assigned a supporter
      who will monitor participant's progress throughout the trial. Once a participant begins their
      chosen programme, they will receive a message from their supporter at their first log-in.
      This message welcomes them to the programme, highlights aspects of it and encourages them in
      the use of it. Weekly, supporters will log in and review participants progress, leaving
      feedback for them and responding to the work they have completed. Supporters will be BABCP
      accredited cognitive behavioural psychotherapists and psychological well-being practitioners
      who are also BABCP accredited or currently in supervised training for accreditation, provided
      by Nuffield Health EAP clinical support services. Each supporter will provide post-session
      feedback of between 10 and 15 minutes per participant per session.

      Face to face counselling/psychotherapy group:

      Once the trial starts, those beginning face-to-face services will be approached to
      participate in the research by a member of the EAP. Those who wish to participate will then
      sign a paper/ digital on iPad consent form and will complete measures at baseline and
      post-treatment, as per the schedule of assessment. Risk will be monitored by the clinician
      responsible for the participant.

      The study is an open feasibility trial that uses standard instruments to assess symptoms of
      anxiety, depression and stress and adjustment psychopathology. It does this using reliable
      and valid instruments, including:

      Patient Health Questionnaire (PHQ-4) a self-report measure of depression and anxiety that has
      been widely used in screening, primary care, and research. The PHQ-4 items reflect the
      diagnostic criteria for depression outlined by the Diagnostic and Statistical Manual of
      Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR).

      Perceived Stress Scale (PSS-4): a self-report measure of non-specific perceived stress. Based
      on Lazarus's transactional model of stress respondents rate how unpredictable,
      uncontrollable, and overloaded they appraise their life to be. Items are answered on a
      5-point Likert scale (0= never, 1=almost never, 2=sometimes, 3=fairly often, 4=very often)
      referring to the past month.

      Health and Work Performance Questionnaire - Short Form: a brief self-report measure designed
      to estimate the workplace costs of health difficulties in two domains: absenteeism and
      reduced job performance. Validation studies have demonstrated significant correlations
      between self-reported HPQ scores and archival pay roll and performance assessments. The HPQ
      has been demonstrated to be valid, reliable and sensitive to change and recommended for use
      in Internet-delivered environments.

      Satisfaction with Treatment (SAT) Questionnaire: includes nine quantitative items rated on a
      scale from 0 to 4 (e.g., How did this online treatment compare to previous treatments? 0 =
      'Much better' to 4 = 'Not at all good'). The Satisfaction with Treatment questionnaire also
      contains two qualitative questions asking participants to describe what they liked most and
      least about the Internet-delivered intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PHQ-4
time frame: Up to 4-months
description: Patient health Questionnaire
measure: PSS-4
time frame: Up to 4-months
description: Perceived Stress Scale-4 (PSS-4)
measure: Health and Work Performance Questionnaire (HPQ-SF)
time frame: Up to 4-months
description: Health and Work Performance Questionnaire
measure: Satisfaction with Treatment Questionnaire (SAT)
time frame: 8 weeks
description: Satisfaction with Treatment Questionnaire (SAT)
arm group label: Space from depression
arm group type: Experimental
description: Space from depression is an 8 module CBT-based intervention.
arm group label: Space from Anxiety
arm group type: Experimental
description: Space from anxiety CBT is an 8 module CBT-based intervention.
arm group label: Space from stress
arm group type: Experimental
description: Space from stress CBT is an 8 module CBT-based intervention.
arm group label: Face-to-face counselling
arm group type: Active Comparator
description: Face-to-face counselling
intervention type: Behavioral
intervention name: Space from Depression
description: The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
arm group label: Space from depression
intervention type: Behavioral
intervention name: Space from Anxiety
description: The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
arm group label: Space from Anxiety
intervention type: Behavioral
intervention name: Space from Stress
description: The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014).The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
arm group label: Space from stress
intervention type: Behavioral
intervention name: Face-to-face counselling
description: Face-to-face counselling
arm group label: Face-to-face counselling
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Derek Richards, PhD
role: Principal Investigator
affiliation: SilverCloud Health
facility: 
country: Ireland
url: http://www.silvercloudhealth.com
description: SilverCloud website
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PMID: 11556941
citation: American Psychiatric Association. Diagnostic and statistical manual of mental disorders (DSM-IV-TR). 4th ed. Washington D.C.: American Psychiatric Association.; 2000.
citation: Cohen S, Williamson G. Perceived stress in a probability sample of the United States. In: S. Spacapan, Oskamp S, editors. The social psychology of health. Newbury Park, CA: Sage; 1988.
citation: Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PMID: 6668417
citation: Kessler R, Petukhova M, McInnes K. World Health Organization Health and Work Performance Questionnaire (HPQ). HPQ Short Form (Absenteeism and Presenteeism Questions and Scoring Rules) Harvard Medical School. 2007.
citation: Kessler RC, Barber C, Beck A, Berglund P, Cleary PD, McKenas D, Pronk N, Simon G, Stang P, Ustun TB, Wang P. The World Health Organization Health and Work Performance Questionnaire (HPQ). J Occup Environ Med. 2003 Feb;45(2):156-74. doi: 10.1097/01.jom.0000052967.43131.51.
PMID: 12625231
citation: Kessler RC, Ames M, Hymel PA, Loeppke R, McKenas DK, Richling DE, Stang PE, Ustun TB. Using the World Health Organization Health and Work Performance Questionnaire (HPQ) to evaluate the indirect workplace costs of illness. J Occup Environ Med. 2004 Jun;46(6 Suppl):S23-37. doi: 10.1097/01.jom.0000126683.75201.c5.
PMID: 15194893
citation: Richards D, Timulak L. Satisfaction with therapist-delivered vs. self-administered online cognitive-behavioural treatments for depression symptoms in college students. British Journal of Guidance & Counselling. 2012;41(2):193-207
responsible party type: Sponsor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Anxiety Disorders
sharing ipd: Undecided