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

NCT06017414 | Completed

• 1 other identifier: IPU_ST_2023_05
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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 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?

Conditions

Psychological Distress

Keywords

Psychological Distress; Emotional Distress; Behavior

Outcome Measures

Primary Outcomes (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.

  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)

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

  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).

  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).

  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 Outcomes (2)

• Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010)

  Intervention condition is measured after the 5 week intervention (Intervention condition only).

• Qualitative questionnaire.

  Intervention condition is measured after the 5 week intervention (Intervention condition only).

Study Arms (4)

Growth Path Intervention

EXPERIMENTAL

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

Waitlist followed by Growth Path Intervention

NO 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.

Listener Training Intervention

EXPERIMENTAL

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

Waitlist followed by Listener Training Intervention

NO 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.

Interventions

Systemic Psychotherapy-informed Growth Path BEHAVIORAL

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.

Growth Path Intervention

Systemic Psychotherapy-informed Listener Training BEHAVIORAL

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.

Listener Training Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Refusal to consent with data use.

Sponsors & Collaborators

• Gunther Meinlschmidt: lead

Study Sites (1)

International Psychoanalytic University Berlin

Berlin, Brandenburg, 10555, Germany

Location

Related Publications (22)

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  PMID: 40329383 DERIVED

MeSH Terms

Conditions

Behavior

Study Officials

• Gunther Meinlschmidt, PhD

  International Psychoanalytic University Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 30, 2023
• Study Start: August 22, 2023
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)