xml: <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/NCT06017414</url>
    </required_header>
    <id_info>
      <org_study_id>IPU_ST_2023_05</org_study_id>
      <nct_id>NCT06017414</nct_id>
    </id_info>
    <brief_title>Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting</brief_title>
    <official_title>Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gunther Meinlschmidt</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>International Psychoanalytic University Berlin</source>
    <oversight_info>
      <has_dmc>No</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 main goal of this project is to address several gaps in the current literature in an&#xD;
        exploratory way, by generating data via a synthesized research design. There are three fields&#xD;
        of research this project seeks to have a meaningful impact on: the digital implementation of&#xD;
        systemic psychotherapy-informed principles and approaches into unguided self-help growth&#xD;
        paths, the training of paraprofessional mental health service providers with systemic&#xD;
        psychotherapy-informed listener training, and the utilization of paraprofessional mental&#xD;
        health service providers in the delivery of online guided systemic psychotherapy-informed&#xD;
        self-help interventions.&#xD;
  &#xD;
        This impact will be derived from addressing the following research questions:&#xD;
  &#xD;
          -  Are online self-help interventions based on systemic psychotherapy approaches and&#xD;
             principles feasible?&#xD;
  &#xD;
          -  Are online self-help interventions based on systemic psychotherapy approaches and&#xD;
             principles efficacious (as compared to a waitlist), indicated by mental-health-related&#xD;
             outcomes of participants?&#xD;
  &#xD;
          -  Is training of paraprofessionals in guiding the use of self-help interventions based on&#xD;
             systemic psychotherapy approaches and principles feasible?&#xD;
  &#xD;
          -  Is this training of paraprofessionals based on systemic psychotherapy approaches and&#xD;
             principles efficacious (as compared to a waitlist), indicated by mental-health-related&#xD;
             outcomes of trainees?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A comprehensive systematic review was published showing the efficacy and effectiveness of&#xD;
        Systemic Psychotherapy in treating the most common psychological disorders. It is important&#xD;
        to critically evaluate Systemic Psychotherapy to identify the most promising paths forward.&#xD;
        One such promising path lies in online self-help interventions (OSIs). OSIs can be broadly&#xD;
        divided into guided and unguided modes of self-help, with the former showing better efficacy&#xD;
        than the latter. This distinction notwithstanding, unguided OSIs have been shown to be&#xD;
        effective in the treatment of anxiety, depression, the prevention of suicides, and numerous&#xD;
        other psychological disorders and conditions. From a public health perspective, OSIs are&#xD;
        particularly interesting as they promise to address several obstacles to conventional mental&#xD;
        health care provision and harness patients' capacities for self-help. Additionally, their&#xD;
        scalability might facilitate the provision of services to target groups that could otherwise&#xD;
        not be reached. Platforms such as &quot;7 Cups&quot; (https://www.7cups.com), which provides OSIs&#xD;
        (called Growth Paths), text-based paraprofessional peer support, paraprofessional training&#xD;
        (called Listener Training), and signposting to professional services, have been identified as&#xD;
        particularly effective in incorporating this approach. Platforms such as 7 Cups, whose peer&#xD;
        support programme has received some attention, warrant further scrutiny. While it is&#xD;
        acknowledged as an important part of improving access to mental health care globally, there&#xD;
        is only one published study on an OSI explicitly incorporating methods and techniques&#xD;
        associated with Systemic Psychotherapy and no studies examining paraprofessional training in&#xD;
        a widely accessible online platform such as 7 Cups. This exploratory study aims to make a&#xD;
        timely and meaningful contribution towards the gaps in the current literature.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 22, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 31, 2024</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>
      <intervention_model_description>Our study is comprised of two main components:&#xD;
  An exploratory randomized, natural setting, pre-post-follow-up study design based on systemic principles and techniques assessing changes over time, and comparing:&#xD;
  the OSI/growth path training condition with a waitlist comparator condition,&#xD;
  paraprofessional provider/listener training condition with a waitlist comparator condition.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Kessler Psychological Distress Scale 6 (K6) (Short version of the K10) (Cornelius et al., 2013; Kessler et al., 2002).</measure>
      <time_frame>Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.</time_frame>
      <description>The K6 is a standardized self-reported outcome assessment tool used to measure global non-specific psychological distress with questions relating to depressive and anxiety symptoms. The K6 consists of 6 items asking people to rate their emotional states on a 5-point Likert scale ranging from ''All the time'' to ''None of the time''. Scores are summed and yield a score of 0 to 24. Higher scores indicate increased non-specified psychological distress.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Perceived Stress Scale 4 (PSS-4) (Short version of the PSS-10) (Warttig et al., 2013).</measure>
      <time_frame>Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.</time_frame>
      <description>The PSS-4 is a standardized patient-reported outcome assessment tool used to measure global perceptions of stress from the individual's perspective. The PSS-4 consists of 4 items asking people to evaluate their experience of stressful situations on a 5-point Likert scale ranging from 'never' to 'very often'. Scores are summed and yield a score of 0 to 16. The higher the score on the PSS-4, the greater the person evaluates that the stressful situations are beyond their ability to deal with them.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire (PHQ-4) (Kroenke, Spitzer, &amp; Williams, 2003).</measure>
      <time_frame>Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.</time_frame>
      <description>The PHQ-4 consists of the first two items of the PHQ-9 and GAD-7, respectively. This comprises the two principal DSM items for major depressive disorder and generalized anxiety disorder, respectively. Each ranges from a score of 0 to 6. The PHQ-4 uses a on a 4-point Likert scale ranging from 'not at all' to 'nearly every day'. Higher scores indicate higher levels of depressive and anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Multidimensional Mood State Questionnaire (MDMQ, good-bad subscale) (English-language version of MDBF) (Steyer, Schwenkmezger, Notz, &amp; Eid, 1997).</measure>
      <time_frame>Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.</time_frame>
      <description>The MDBF measures participant current mood (good-bad). The MDBF uses a 6-point Likert scale ranging from 'definitely not' to 'extremely'. Scores are summed, yielding a total score of 4 to 24. Higher scores indicate higher good mood scores.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010)</measure>
      <time_frame>Intervention condition is measured after the 5 week intervention (Intervention condition only).</time_frame>
      <description>Assesses the Usability of the intervention delivery. The UMUX-LITE uses a 7-point Likert scale. Item responses are recoded to compute a score ranging from 0 to 100. Higher scores indicate increased ratings of the system's capabilities and ease of use.</description>
    </other_outcome>
    <other_outcome>
      <measure>Qualitative questionnaire.</measure>
      <time_frame>Intervention condition is measured after the 5 week intervention (Intervention condition only).</time_frame>
      <description>By using Revicki (2003), Ghani (2015) and Johnson et al. (2011) as guidance a set of questions were designed to get further information and details about the experience and quality of the intervention. Example questions include: What would improve the growth path or listener training for you?</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Psychological Distress</condition>
    <arm_group>
      <arm_group_label>Growth Path Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants for this arm are members of the 7 Cups platform (signed up as 'members', but not signed up as 'listeners') who will receive the Systemic Psychotherapy-informed growth path intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist followed by Growth Path Intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants for this arm are members of the 7 Cups platform (signed up as 'members', but not signed up as 'listeners'). The waitlist comparator condition has 7 Cups access and use as usual during the waitlist period. Participants will receive access to the Systemic Psychotherapy-informed growth path intervention after the waitlist condition of 7 weeks is completed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Listener Training Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants for this arm are listeners on the 7 Cups platform (signed up as 'listeners', but not signed up as 'members') who will receive the Systemic Psychotherapy-informed listener training intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Waitlist followed by Listener Training Intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants for this arm are listeners on the 7 Cups platform (signed up as 'listeners', but not signed up as 'members'). The waitlist comparator condition has 7 Cups access and use as usual during the waitlist period. Participants will receive access to the Systemic Psychotherapy-informed listener training intervention after the waitlist condition of 7 weeks is completed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Systemic Psychotherapy-informed Growth Path</intervention_name>
      <description>A self-guided program lasting 5 weeks on the 7 Cups platform. The self-help intervention aims to support members to explore their relationships, situations, and goals.</description>
      <arm_group_label>Growth Path Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Systemic Psychotherapy-informed Listener Training</intervention_name>
      <description>A self-guided program lasting 5 weeks on the 7 Cups platform. The self-help intervention encourages listeners to explore their relationships, situations, and goals and think about how they would support members working through their own relationships, situations, and goals.</description>
      <arm_group_label>Listener Training Intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Have been signed up on the 7Cups platform as a member or listener for a minimum of 3&#xD;
               months.&#xD;
  &#xD;
            -  The intended 7Cups member is &quot;anyone who wants to talk about whatever is on their&#xD;
               mind&quot; and the intended 7Cups listener is anyone who does the basic training and &quot;wants&#xD;
               to listen to members&quot; (https://www.7cups.com/about/), including given consent to data&#xD;
               use.&#xD;
  &#xD;
            -  Have actively used the 7Cups platform as a member or listener by logging into the&#xD;
               platform at least once in the last 2 weeks.&#xD;
  &#xD;
            -  Agree to participate in our study and provide consent to data usage.&#xD;
  &#xD;
            -  Aged 18 years or above.&#xD;
  &#xD;
            -  English language (sufficient capacity to interact with the 7Cups platform and&#xD;
               participate in the assessments).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Refusal to consent with data use.&#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>Gunther Meinlschmidt, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>International Psychoanalytic University Berlin</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pieter E Erasmus, M.A.</last_name>
      <phone>+48 530 728 373</phone>
      <email>pieter.erasmus@ipu-berlin.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Prof. Dr. Meinlschmidt</last_name>
      <phone>+49 30 300 117</phone>
      <phone_ext>710</phone_ext>
      <email>gunther.meinlschmidt@ipu-berlin.de</email>
    </overall_contact_backup>
    <reference>
      <citation>Andersson G. Internet interventions: Past, present and future. Internet Interv. 2018 Apr 6;12:181-188. doi: 10.1016/j.invent.2018.03.008. eCollection 2018 Jun.</citation>
      <PMID>30135782</PMID>
    </reference>
    <reference>
      <citation>Baumel A, Tinkelman A, Mathur N, Kane JM. Digital Peer-Support Platform (7Cups) as an Adjunct Treatment for Women With Postpartum Depression: Feasibility, Acceptability, and Preliminary Efficacy Study. JMIR Mhealth Uhealth. 2018 Feb 13;6(2):e38. doi: 10.2196/mhealth.9482.</citation>
      <PMID>29439944</PMID>
    </reference>
    <reference>
      <citation>Cornelius BL, Groothoff JW, van der Klink JJ, Brouwer S. The performance of the K10, K6 and GHQ-12 to screen for present state DSM-IV disorders among disability claimants. BMC Public Health. 2013 Feb 12;13:128. doi: 10.1186/1471-2458-13-128.</citation>
      <PMID>23402478</PMID>
    </reference>
    <reference>
      <citation>Cuijpers P, Noma H, Karyotaki E, Cipriani A, Furukawa TA. Effectiveness and Acceptability of Cognitive Behavior Therapy Delivery Formats in Adults With Depression: A Network Meta-analysis. JAMA Psychiatry. 2019 Jul 1;76(7):700-707. doi: 10.1001/jamapsychiatry.2019.0268. Erratum In: JAMA Psychiatry. 2019 Jul 17;: JAMA Psychiatry. 2022 Feb 1;79(2):180.</citation>
      <PMID>30994877</PMID>
    </reference>
    <reference>
      <citation>Fairburn CG, Patel V. The impact of digital technology on psychological treatments and their dissemination. Behav Res Ther. 2017 Jan;88:19-25. doi: 10.1016/j.brat.2016.08.012.</citation>
      <PMID>28110672</PMID>
    </reference>
    <reference>
      <citation>Finstad K. The usability metric for user experience. Interacting with computers. 2010; 22(5): 323-327. doi: 10.1016/j.intcom.2010.04.004</citation>
    </reference>
    <reference>
      <citation>Ghani MA, Brown SE, Khan F, Wickersham JA, Lim SH, Dhaliwal SK, Kamarulzaman A, Altice FL. An exploratory qualitative assessment of self-reported treatment outcomes and satisfaction among patients accessing an innovative voluntary drug treatment centre in Malaysia. Int J Drug Policy. 2015 Feb;26(2):175-82. doi: 10.1016/j.drugpo.2014.10.002. Epub 2014 Oct 28.</citation>
      <PMID>25577322</PMID>
    </reference>
    <reference>
      <citation>Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG). (24.05.2017). Bericht Nr. 513, Systemische Therapie bei Erwachsenen als Psychotherapieverfahren, Abschlussbericht, Auftrag N14-02, Version 1.0; https://www.iqwig.de/download/n14-02_abschlussbericht_systemische-therapie-bei-erwachsenen_v1-0.pdf(accessed 01.09.2021)</citation>
    </reference>
    <reference>
      <citation>Johnsen AT, Petersen MA, Pedersen L, Groenvold M. Development and initial validation of the Three-Levels-of-Needs Questionnaire for self-assessment of palliative needs in patients with cancer. J Pain Symptom Manage. 2011 Jun;41(6):1025-39. doi: 10.1016/j.jpainsymman.2010.08.013. Epub 2011 Feb 9.</citation>
      <PMID>21306865</PMID>
    </reference>
    <reference>
      <citation>Karyotaki E, Riper H, Twisk J, Hoogendoorn A, Kleiboer A, Mira A, Mackinnon A, Meyer B, Botella C, Littlewood E, Andersson G, Christensen H, Klein JP, Schroder J, Breton-Lopez J, Scheider J, Griffiths K, Farrer L, Huibers MJ, Phillips R, Gilbody S, Moritz S, Berger T, Pop V, Spek V, Cuijpers P. Efficacy of Self-guided Internet-Based Cognitive Behavioral Therapy in the Treatment of Depressive Symptoms: A Meta-analysis of Individual Participant Data. JAMA Psychiatry. 2017 Apr 1;74(4):351-359. doi: 10.1001/jamapsychiatry.2017.0044.</citation>
      <PMID>28241179</PMID>
    </reference>
    <reference>
      <citation>Karyotaki E, van Ballegooijen W. Digital self-help interventions for suicidal ideation and behaviour. Lancet Digit Health. 2020 Jan;2(1):e4-e5. doi: 10.1016/S2589-7500(19)30215-8. Epub 2019 Nov 29. No abstract available.</citation>
      <PMID>33328038</PMID>
    </reference>
    <reference>
      <citation>Kessler RC, Andrews G, Colpe LJ, Hiripi E, Mroczek DK, Normand SL, Walters EE, Zaslavsky AM. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002 Aug;32(6):959-76. doi: 10.1017/s0033291702006074.</citation>
      <PMID>12214795</PMID>
    </reference>
    <reference>
      <citation>Kroenke K, Spitzer RL, Williams JB, Lowe B. An ultra-brief screening scale for anxiety and depression: the PHQ-4. Psychosomatics. 2009 Nov-Dec;50(6):613-21. doi: 10.1176/appi.psy.50.6.613.</citation>
      <PMID>19996233</PMID>
    </reference>
    <reference>
      <citation>Messner, E. M., &amp; Feikes, K. I. (2021). Systemische Therapie goes online. Psychotherapeut, 66, 501-510. https://doi.org/10.1007/s00278-021-00544-z</citation>
    </reference>
    <reference>
      <citation>Naslund JA, Shidhaye R, Patel V. Digital Technology for Building Capacity of Nonspecialist Health Workers for Task Sharing and Scaling Up Mental Health Care Globally. Harv Rev Psychiatry. 2019 May/Jun;27(3):181-192. doi: 10.1097/HRP.0000000000000217.</citation>
      <PMID>30958400</PMID>
    </reference>
    <reference>
      <citation>Pauley D, Cuijpers P, Papola D, Miguel C, Karyotaki E. Two decades of digital interventions for anxiety disorders: a systematic review and meta-analysis of treatment effectiveness. Psychol Med. 2023 Jan;53(2):567-579. doi: 10.1017/S0033291721001999. Epub 2021 May 28.</citation>
      <PMID>34047264</PMID>
    </reference>
    <reference>
      <citation>Revicki DA. Patient assessment of treatment satisfaction: methods and practical issues. Gut. 2004 May;53 Suppl 4(Suppl 4):iv40-4. doi: 10.1136/gut.2003.034322.</citation>
      <PMID>15082613</PMID>
    </reference>
    <reference>
      <citation>Sin J, Galeazzi G, McGregor E, Collom J, Taylor A, Barrett B, Lawrence V, Henderson C. Digital Interventions for Screening and Treating Common Mental Disorders or Symptoms of Common Mental Illness in Adults: Systematic Review and Meta-analysis. J Med Internet Res. 2020 Sep 2;22(9):e20581. doi: 10.2196/20581.</citation>
      <PMID>32876577</PMID>
    </reference>
    <reference>
      <citation>Steyer, R., Schwenkmezger, P., Notz, P. und Eid, M. (1997). Der Mehrdimensionale Befindlichkeitsfragebogen (MDBF). Göttingen: Hogrefe.</citation>
    </reference>
    <reference>
      <citation>Torok M, Han J, Baker S, Werner-Seidler A, Wong I, Larsen ME, Christensen H. Suicide prevention using self-guided digital interventions: a systematic review and meta-analysis of randomised controlled trials. Lancet Digit Health. 2020 Jan;2(1):e25-e36. doi: 10.1016/S2589-7500(19)30199-2. Epub 2019 Nov 29.</citation>
      <PMID>33328037</PMID>
    </reference>
    <reference>
      <citation>Warttig SL, Forshaw MJ, South J, White AK. New, normative, English-sample data for the Short Form Perceived Stress Scale (PSS-4). J Health Psychol. 2013 Dec;18(12):1617-28. doi: 10.1177/1359105313508346. Epub 2013 Oct 22.</citation>
      <PMID>24155195</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>International Psychoanalytic University Berlin</investigator_affiliation>
      <investigator_full_name>Gunther Meinlschmidt</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>Psychological Distress</keyword>
    <keyword>Emotional Distress</keyword>
    <keyword>Behavior</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06017414
  org study id: IPU_ST_2023_05
  nct id: NCT06017414
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main goal of this project is to address several gaps in the current literature in an
        exploratory way, by generating data via a synthesized research design. There are three fields
        of research this project seeks to have a meaningful impact on: the digital implementation of
        systemic psychotherapy-informed principles and approaches into unguided self-help growth
        paths, the training of paraprofessional mental health service providers with systemic
        psychotherapy-informed listener training, and the utilization of paraprofessional mental
        health service providers in the delivery of online guided systemic psychotherapy-informed
        self-help interventions.
  
        This impact will be derived from addressing the following research questions:
  
          -  Are online self-help interventions based on systemic psychotherapy approaches and
             principles feasible?
  
          -  Are online self-help interventions based on systemic psychotherapy approaches and
             principles efficacious (as compared to a waitlist), indicated by mental-health-related
             outcomes of participants?
  
          -  Is training of paraprofessionals in guiding the use of self-help interventions based on
             systemic psychotherapy approaches and principles feasible?
  
          -  Is this training of paraprofessionals based on systemic psychotherapy approaches and
             principles efficacious (as compared to a waitlist), indicated by mental-health-related
             outcomes of trainees?
  A comprehensive systematic review was published showing the efficacy and effectiveness of
        Systemic Psychotherapy in treating the most common psychological disorders. It is important
        to critically evaluate Systemic Psychotherapy to identify the most promising paths forward.
        One such promising path lies in online self-help interventions (OSIs). OSIs can be broadly
        divided into guided and unguided modes of self-help, with the former showing better efficacy
        than the latter. This distinction notwithstanding, unguided OSIs have been shown to be
        effective in the treatment of anxiety, depression, the prevention of suicides, and numerous
        other psychological disorders and conditions. From a public health perspective, OSIs are
        particularly interesting as they promise to address several obstacles to conventional mental
        health care provision and harness patients' capacities for self-help. Additionally, their
        scalability might facilitate the provision of services to target groups that could otherwise
        not be reached. Platforms such as "7 Cups" (https://www.7cups.com), which provides OSIs
        (called Growth Paths), text-based paraprofessional peer support, paraprofessional training
        (called Listener Training), and signposting to professional services, have been identified as
        particularly effective in incorporating this approach. Platforms such as 7 Cups, whose peer
        support programme has received some attention, warrant further scrutiny. While it is
        acknowledged as an important part of improving access to mental health care globally, there
        is only one published study on an OSI explicitly incorporating methods and techniques
        associated with Systemic Psychotherapy and no studies examining paraprofessional training in
        a widely accessible online platform such as 7 Cups. This exploratory study aims to make a
        timely and meaningful contribution towards the gaps in the current literature.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Our study is comprised of two main components:
  An exploratory randomized, natural setting, pre-post-follow-up study design based on systemic principles and techniques assessing changes over time, and comparing:
  the OSI/growth path training condition with a waitlist comparator condition,
  paraprofessional provider/listener training condition with a waitlist comparator condition.
  primary purpose: Other
  masking: None (Open Label)
  measure: Kessler Psychological Distress Scale 6 (K6) (Short version of the K10) (Cornelius et al., 2013; Kessler et al., 2002).
  time frame: Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.
  description: The K6 is a standardized self-reported outcome assessment tool used to measure global non-specific psychological distress with questions relating to depressive and anxiety symptoms. The K6 consists of 6 items asking people to rate their emotional states on a 5-point Likert scale ranging from ''All the time'' to ''None of the time''. Scores are summed and yield a score of 0 to 24. Higher scores indicate increased non-specified psychological distress.
  measure: Perceived Stress Scale 4 (PSS-4) (Short version of the PSS-10) (Warttig et al., 2013).
  time frame: Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.
  description: The PSS-4 is a standardized patient-reported outcome assessment tool used to measure global perceptions of stress from the individual's perspective. The PSS-4 consists of 4 items asking people to evaluate their experience of stressful situations on a 5-point Likert scale ranging from 'never' to 'very often'. Scores are summed and yield a score of 0 to 16. The higher the score on the PSS-4, the greater the person evaluates that the stressful situations are beyond their ability to deal with them.
  measure: Patient Health Questionnaire (PHQ-4) (Kroenke, Spitzer, & Williams, 2003).
  time frame: Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.
  description: The PHQ-4 consists of the first two items of the PHQ-9 and GAD-7, respectively. This comprises the two principal DSM items for major depressive disorder and generalized anxiety disorder, respectively. Each ranges from a score of 0 to 6. The PHQ-4 uses a on a 4-point Likert scale ranging from 'not at all' to 'nearly every day'. Higher scores indicate higher levels of depressive and anxiety symptoms.
  measure: Multidimensional Mood State Questionnaire (MDMQ, good-bad subscale) (English-language version of MDBF) (Steyer, Schwenkmezger, Notz, & Eid, 1997).
  time frame: Intervention condition is measured before, directly after, and 2 weeks after the 5 week intervention. Waitlist condition is measured at parallel timepoints, then receives the intervention and follows the intervention condition measurement time frame.
  description: The MDBF measures participant current mood (good-bad). The MDBF uses a 6-point Likert scale ranging from 'definitely not' to 'extremely'. Scores are summed, yielding a total score of 4 to 24. Higher scores indicate higher good mood scores.
  measure: Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010)
  time frame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
  description: Assesses the Usability of the intervention delivery. The UMUX-LITE uses a 7-point Likert scale. Item responses are recoded to compute a score ranging from 0 to 100. Higher scores indicate increased ratings of the system's capabilities and ease of use.
  measure: Qualitative questionnaire.
  time frame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
  description: By using Revicki (2003), Ghani (2015) and Johnson et al. (2011) as guidance a set of questions were designed to get further information and details about the experience and quality of the intervention. Example questions include: What would improve the growth path or listener training for you?
  arm group label: Growth Path Intervention
  arm group type: Experimental
  description: Participants for this arm are members of the 7 Cups platform (signed up as 'members', but not signed up as 'listeners') who will receive the Systemic Psychotherapy-informed growth path intervention.
  arm group label: Waitlist followed by Growth Path Intervention
  arm group type: No Intervention
  description: Participants for this arm are members of the 7 Cups platform (signed up as 'members', but not signed up as 'listeners'). The waitlist comparator condition has 7 Cups access and use as usual during the waitlist period. Participants will receive access to the Systemic Psychotherapy-informed growth path intervention after the waitlist condition of 7 weeks is completed.
  arm group label: Listener Training Intervention
  arm group type: Experimental
  description: Participants for this arm are listeners on the 7 Cups platform (signed up as 'listeners', but not signed up as 'members') who will receive the Systemic Psychotherapy-informed listener training intervention.
  arm group label: Waitlist followed by Listener Training Intervention
  arm group type: No Intervention
  description: Participants for this arm are listeners on the 7 Cups platform (signed up as 'listeners', but not signed up as 'members'). The waitlist comparator condition has 7 Cups access and use as usual during the waitlist period. Participants will receive access to the Systemic Psychotherapy-informed listener training intervention after the waitlist condition of 7 weeks is completed.
  intervention type: Behavioral
  intervention name: Systemic Psychotherapy-informed Growth Path
  description: A self-guided program lasting 5 weeks on the 7 Cups platform. The self-help intervention aims to support members to explore their relationships, situations, and goals.
  arm group label: Growth Path Intervention
  intervention type: Behavioral
  intervention name: Systemic Psychotherapy-informed Listener Training
  description: A self-guided program lasting 5 weeks on the 7 Cups platform. The self-help intervention encourages listeners to explore their relationships, situations, and goals and think about how they would support members working through their own relationships, situations, and goals.
  arm group label: Listener Training Intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Gunther Meinlschmidt, PhD
  role: Principal Investigator
  affiliation: International Psychoanalytic University Berlin
  last name: Pieter E Erasmus, M.A.
  phone: +48 530 728 373
  email: pieter.erasmus@ipu-berlin.de
  last name: Prof. Dr. Meinlschmidt
  phone: +49 30 300 117
  phone ext: 710
  email: gunther.meinlschmidt@ipu-berlin.de
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  PMID: 29439944
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  PMID: 24155195
  responsible party type: Sponsor-Investigator
  investigator affiliation: International Psychoanalytic University Berlin
  investigator full name: Gunther Meinlschmidt
  investigator title: Prof. Dr.
  sharing ipd: No