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

November 21, 2023 updated by: Gunther Meinlschmidt

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Brandenburg
      • Berlin, Brandenburg, Germany, 10555
        • Recruiting
        • International Psychoanalytic University Berlin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Refusal to consent with data use.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Growth Path Intervention
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.
Behavioral: Systemic Psychotherapy-informed Growth Path
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.
No Intervention: Waitlist followed by Growth Path Intervention
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.
Experimental: Listener Training Intervention
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.
Behavioral: Systemic Psychotherapy-informed Listener Training
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.
No Intervention: Waitlist followed by Listener Training Intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010)
Time Frame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
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.
Intervention condition is measured after the 5 week intervention (Intervention condition only).
Qualitative questionnaire.
Time Frame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
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?
Intervention condition is measured after the 5 week intervention (Intervention condition only).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gunther Meinlschmidt

Investigators

  • Principal Investigator: Gunther Meinlschmidt, PhD, International Psychoanalytic University Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IPU_ST_2023_05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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