Systemic therapy informed self-help and paraprofessional training in a naturalistic setting: study protocol of a digital randomised trial.

Background: Multiple studies have shown the efficacy of Systemic Psychotherapy (ST) approaches as a promising path to address various mental health disorders and alleviate psychological distress. One promising path that requires further investigation is online self-help interventions and paraprofessional training. Our study aims to evaluate the implementation of delivering ST-informed online self-help interventions (OSI) and paraprofessional training in a naturalistic setting via the 7 Cups platform.

Methods: Our exploratory, randomised, controlled, pre-post-follow-up study is recruiting two samples of participants: (i) for the ST-informed online self-help/growth path intervention amongst members on the 7 Cups platform, (ii) for the ST-informed online paraprofessional/listener training intervention amongst members who have registered as 'listener' status. The sample size target is N = 200 participants, randomly assigning and comparing 50 OSI member participants to 50 waitlist member participants and 50 paraprofessional/listener training listeners to 50 waitlist listener participants. Our sample size justification, based on previous feasibility studies and guidelines, suggests that a sample size of 50 per group, accounting for a 25% attrition rate, is sufficient to assess feasibility in online family, e-health, and mental health trials, while maintaining narrow margins of error for confidence intervals and primary outcome parameters. The primary outcome is non-specific psychological distress (Kessler Psychological Distress Scale; K6); secondary outcomes include perceived stress, anxiety and depressive symptoms, and momentary mood. To estimate intervention effects, we intend to conduct generalised linear mixed models of primary, and secondary parameters, adjusted for potential covariates (e.g., gender, age categories, socioeconomic status) as fixed effects.

Conclusions: Despite the great need for mental health interventions, there is limited research available showing the efficacy of digitally delivered ST-informed interventions. This exploratory, randomized, controlled trial will yield robust insights into the feasibility, challenges, and user experience of novel, digital interventions on a widely accessible online platform (7 Cups). Background: ClinicalTrials.gov (NCT06017414, updated 21.11.2023). Registered 29 August 2023, https://clinicaltrials.gov/study/NCT06017414 .