Clinical trial NCT06017414: Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting
Official title: Systemic Psychotherapy-informed Self-help and Paraprofessional Training in a Naturalistic Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Distress
Keywords: Psychological Distress
Emotional Distress
Behavior
Lead sponsor: International Psychoanalytic University Berlin
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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:

1. the OSI/growth path training condition with a waitlist comparator condition,
2. paraprofessional provider/listener training condition with a waitlist comparator condition.
Primary purpose: OTHER

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?

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Kessler Psychological Distress Scale 6 (K6) (Short version of the K10) (Cornelius et al., 2013; Kessler et al., 2002).
timeFrame: 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:
measure: Perceived Stress Scale 4 (PSS-4) (Short version of the PSS-10) (Warttig et al., 2013).
timeFrame: 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.
measure: Patient Health Questionnaire (PHQ-4) (Kroenke, Spitzer, & Williams, 2003).
timeFrame: 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.
measure: Multidimensional Mood State Questionnaire (MDMQ, good-bad subscale) (English-language version of MDBF) (Steyer, Schwenkmezger, Notz, & Eid, 1997).
timeFrame: 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:
measure: Usability Metric for User Experience Questionnaire (UMUX-LITE) (Finstad, 2010)
timeFrame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
measure: Qualitative questionnaire.
timeFrame: Intervention condition is measured after the 5 week intervention (Intervention condition only).
Locations:
city: Berlin
country: Germany
facility: International Psychoanalytic University Berlin
state: Brandenburg
Study officials:
affiliation: International Psychoanalytic University Berlin
name: Gunther Meinlschmidt, PhD
role: PRINCIPAL_INVESTIGATOR
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