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Psychological DistressNCT06017414

Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting

A study testing Systemic Psychotherapy-informed Growth Path and Systemic Psychotherapy-informed Listener Training in people with Psychological Distress, run by Gunther Meinlschmidt at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychological Distress
What is being tested?
Systemic Psychotherapy-informed Growth Path and Systemic Psychotherapy-informed Listener Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
1 siteGermany
Study dates
22 Aug 2023to 31 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have been signed up on the 7Cups platform as a member or listener for a minimum of 3 months.
  • The intended 7Cups member is "anyone who wants to talk about whatever is on their mind" and the intended 7Cups listener is anyone who does the basic training and "wants to listen to members" (https://www.7cups.com/about/), including given consent to data use.
  • Have actively used the 7Cups platform as a member or listener by logging into the platform at least once in the last 2 weeks.
  • Agree to participate in our study and provide consent to data usage.
  • Aged 18 years or above.
  • English language (sufficient capacity to interact with the 7Cups platform and participate in the assessments).

Who cannot join

  • Refusal to consent with data use.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • International Psychoanalytic University Berlin

    Berlin, Brandenburg, 10555

Other trials in Germany

About this study

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?
Read the detailed description

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.

Being tested
Systemic Psychotherapy-informed Growth Path, Systemic Psychotherapy-informed Listener Training
Keywords
Psychological Distress, Emotional Distress, Behavior
Medical subject headings
Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systemic Psychotherapy-informed Growth PathBehavioural

    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.

  • Systemic Psychotherapy-informed Listener TrainingBehavioural

    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.

Study groups in NCT06017414
Study groupRoleWhat they receive
Growth Path InterventionExperimentalParticipants 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.
Receives: Behavioral: Systemic Psychotherapy-informed Growth Path
Waitlist followed by Growth Path InterventionNo interventionParticipants 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.
Listener Training InterventionExperimentalParticipants 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.
Receives: Behavioral: Systemic Psychotherapy-informed Listener Training
Waitlist followed by Listener Training InterventionNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Kessler Psychological Distress Scale 6 (K6) (Short version of the K10) (Cornelius et al., 2013; Kessler et al., 2002).

    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.

    Measured: 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.

Secondary outcomes (3)

  1. Perceived Stress Scale 4 (PSS-4) (Short version of the PSS-10) (Warttig et al., 2013).

    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.

    Measured: 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.

  2. Patient Health Questionnaire (PHQ-4) (Kroenke, Spitzer, & Williams, 2003).

    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.

    Measured: 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.

  3. Multidimensional Mood State Questionnaire (MDMQ, good-bad subscale) (English-language version of MDBF) (Steyer, Schwenkmezger, Notz, & Eid, 1997).

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2023
  2. Study start22 Aug 2023
  3. Primary completion31 Mar 2024
  4. Study completion31 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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: 1. the OSI/growth path training condition with a waitlist comparator condition, 2. paraprofessional provider/listener training condition with a waitlist comparator condition.
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06017414
Sponsor's protocol ID
IPU_ST_2023_05
Status last verified
Jan 2025
First submitted
22 Aug 2023
Last updated
30 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30135782

  • 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.

    PubMed 29439944

  • 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.

    PubMed 23402478

  • 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.

    PubMed 30994877

  • 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.

    PubMed 28110672

  • Finstad K. The usability metric for user experience. Interacting with computers. 2010; 22(5): 323-327. doi: 10.1016/j.intcom.2010.04.004

  • 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.

    PubMed 25577322

  • 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)

  • 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.

    PubMed 21306865

  • 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.

    PubMed 28241179

  • 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.

    PubMed 33328038

  • 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.

    PubMed 12214795

  • 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.

    PubMed 19996233

  • Messner, E. M., & Feikes, K. I. (2021). Systemische Therapie goes online. Psychotherapeut, 66, 501-510. https://doi.org/10.1007/s00278-021-00544-z

  • 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.

    PubMed 30958400

Questions about this trial

What is this clinical trial studying?

A study testing Systemic Psychotherapy-informed Growth Path and Systemic Psychotherapy-informed Listener Training in people with Psychological Distress, run by Gunther Meinlschmidt at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06017414, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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