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

Sponsor

Gunther Meinlschmidt (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06017414

Collaborator

(none)

200

Enrollment

Arms

7.3

Anticipated Duration (Months)

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Psychological Distress	Behavioral: Systemic Psychotherapy-informed Growth Path Behavioral: Systemic Psychotherapy-informed Listener Training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 22, 2023

Anticipated Primary Completion Date :

Mar 31, 2024

Anticipated Study Completion Date :

Mar 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.]
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.
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.]
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.
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.]
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.

Other Outcome Measures

Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010) [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.
Qualitative questionnaire. [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?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Gunther Meinlschmidt

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Gunther Meinlschmidt, Prof. Dr., International Psychoanalytic University Berlin

ClinicalTrials.gov Identifier:

NCT06017414

Other Study ID Numbers:

IPU_ST_2023_05

First Posted:

Aug 30, 2023

Last Update Posted:

Aug 30, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Gunther Meinlschmidt, Prof. Dr., International Psychoanalytic University Berlin

Psychological Distress

Emotional Distress

Behavior

Study Results

No Results Posted as of Aug 30, 2023