An observational study in Psychological Distress, Stress Psychological and Mental Health, sponsored by St.Gallen University of Applied Sciences. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by St.Gallen University of Applied Sciences · Observational
The goal of this observational study is to learn how a community-based peer counselling service works in everyday practice and whether it helps people who are going through a psychologically difficult time. Peer counsellors are trained people with their own lived experience of mental health problems. The service, Peerberatung St. Gallen, already exists in St. Gallen, Switzerland. It offers up to six one-hour counselling sessions per year per client. The study does not change the service or decide who receives it.
The main questions this study aims to answer are:
Clients who use the service will:
Peer counsellors and staff of partner organizations will:
- Fill out a questionnaire about how acceptable, appropriate and practical they find the service Be invited to take part in group discussions (peers) or interviews (staff of organizations)
Mental health and psychosocial support services are shifting towards community-based, rights-oriented models of care. The recovery approach is central to this shift. It emphasizes hope, empowerment and self-determination rather than symptom reduction alone. The World Health Organization (WHO) calls for recovery-oriented services that respect legal capacity, avoid coercion, and promote participation and community inclusion.
Peer support is a core element of recovery-oriented care. WHO defines it as one-to-one or group support provided by people with lived experience of mental health problems to others who wish to benefit from their experience. Recent meta-analyses report small but significant effects of peer support on personal and clinical recovery. However, the quality of the underlying studies is mostly low to moderate, and settings and peer roles vary widely.
Positive trial results do not guarantee successful uptake in routine care. Peer support implementation is often hindered by unclear role descriptions, insufficient supervision and weak organizational embedding. In Switzerland, peer work has developed mainly within inpatient psychiatric institutions. Little is known about how independent, community-based peer services can be implemented and how they work under real-world conditions, particularly in German-speaking countries.
THE SERVICE: Peerberatung St. Gallen (PBSG) is a community-based, peer-led counseling service in the canton of St. Gallen, Switzerland (approx. 535,000 inhabitants). It is funded by the canton through a service agreement and operates alongside existing psychiatric, primary care, outpatient and social services. Before PBSG, no community-based, peer-led counseling service existed in the canton.
The service is delivered by six peer counselors, all trained in EX-IN (Experience Involvement), a recognized qualification for peer work based on lived experience of psychological distress. Peers receive ongoing supervision and continuing education, and lead most operational tasks, including intake. At intake, a peer records the client's concerns and expectations and assigns them to the most suitable peer counselor. Counseling is generally not offered to people who report suicidality, seek a substitute for clinical or psychiatric treatment, want to discuss treatment-specific questions such as medication, or need legal or financial assistance. These people are referred to other services.
Clients receive up to six one-hour sessions, held face-to-face at a place of their choice, online, or by telephone. Each session costs approximately CHF 5.
The study does not change the service and does not assign anyone to it. Clients access PBSG through the regular intake process. Participation in the study is voluntary and separate from receiving counseling.
The study uses an Effectiveness-Implementation Hybrid Type 3 design within the evaluation and implementation phase of the UK Medical Research Council (MRC) Framework for Complex Interventions. The primary focus is on how the service is implemented; effects on clients are assessed secondarily and exploratorily. RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) serves as the summative evaluation framework. A stakeholder analysis maps the regional actors relevant to the service and defines the sampling frame for network partners.
The project consists of three studies with different aims:
Aim 1: To describe changes in clients' subjective recovery, mental well-being and perceived stress over the course of counseling, and their satisfaction with the service (online questionnaires before and at the end of counseling).
Aim 2: To explore how clients experience counseling, which aspects they find helpful or challenging, and how the changes observed under Aim 1 come about (semi-structured interviews, Framework Analysis).
Aim 3: To identify facilitators and barriers to implementing the service from the perspectives of peer counselors and network partners (questionnaires, focus groups, interviews, routine service data and institutional documents).
Findings from all three sub-studies are integrated along the RE-AIM dimensions.
806 studies on the registry are indexed under Stress, Psychological; 131 are open to participants now.
This study's planned enrollment of 65 is below the median of 174 across 143 observational studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →St.Gallen University of Applied Sciences is the lead sponsor of 6 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study takes place in the canton of St. Gallen, Switzerland, and includes three participant groups. (1) Clients: adults aged 18 to 65 living in the canton who experience psychological distress or a psychologically challenging situation and receive peer counseling at Peerberatung St. Gallen through the regular intake process (approximately 40 clients per year; about 24 expected to participate in the surveys and 10-12 in interviews). (2) Peer counselors: all EX-IN-trained peer counselors delivering the service (currently n=6). (3) Network partners: professionals and organizations in the regional care network, such as psychiatric clinics, social institutions, grassroots organizations, cantonal authorities, psychotherapists and general practitioners (about 20-25), identified through a stakeholder analysis.
CLIENTS
Inclusion Criteria (clients):
Additional inclusion criterion for interviews (Aim 2):
- Completed counseling (single session up to the full course of six sessions)
Exclusion Criteria (clients):
Inclusion Criteria (peers):
Exclusion Criteria (peers):
- Not actively delivering counseling at Peerberatung St. Gallen during the data collection period (e.g. extended leave or departure from the service)
Inclusion Criteria (network partners):
Exclusion Criteria (network partners):
Adults (18-65 years) living in the canton of St. Gallen who receive peer counseling from the service. Clients complete online questionnaires before and at the end of counseling (Aim 1). A purposive subsample of approximately 10-12 clients who have completed counseling takes part in a semi-structured interview about their experience of counseling (Aim 2).
All EX-IN-trained peer counselors actively delivering counseling from the service during the data collection period. Peer counselors complete questionnaires on the acceptability, appropriateness and feasibility of the service and take part in focus groups on implementation experience, role development, and facilitators and challenges in delivering counseling (Aim 3).
Professionals and organizations in the regional care network of PBSG, including psychiatric clinics, social institutions, grassroots organizations, cantonal authorities and potential referrers such as psychotherapists and general practitioners, identified through a stakeholder analysis. Network partners complete an anonymous online survey on awareness, referral practice and the acceptability, appropriateness and feasibility of the service. A purposive subset takes part in semi-structured interviews on perceived fit, referral barriers and long-term integration (Aim 3).
Acceptability of the peer counseling service (Acceptability of Intervention Measure, AIM)
Acceptability of the service as perceived by peer counselors and network partners, measured with the Acceptability of Intervention Measure. The AIM consists of 4 items rated on a 5-point scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5; higher scores indicate greater acceptability. Network partners complete the measure only if they are aware of the service or have referred to it. Results are reported descriptively per group.
Time frame: Single assessment during the data collection period (approximately 12 months)
Appropriateness of the peer counseling service (Intervention Appropriateness Measure, IAM)
Perceived fit of the service for the setting and target population, as rated by peer counselors and network partners, measured with the Intervention Appropriateness Measure. The IAM consists of 4 items rated on a 5-point scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5; higher scores indicate greater appropriateness. Network partners complete the measure only if they are aware of the service or have referred to it. Results are reported descriptively per group.
Time frame: Single assessment during the data collection period (approximately 12 months)
Feasibility of the peer counseling service (Feasibility of Intervention Measure, FIM)
Extent to which the service can be successfully delivered, as rated by peer counselors and network partners, measured with the Feasibility of Intervention Measure. The FIM consists of 4 items rated on a 5-point scale (1 = completely disagree to 5 = completely agree). The mean score ranges from 1 to 5; higher scores indicate greater feasibility. Network partners complete the measure only if they are aware of the service or have referred to it. Results are reported descriptively per group.
Time frame: Single assessment during the data collection period (approximately 12 months)
Facilitators and barriers to implementation of the peer counseling service
Facilitators and barriers to implementing the service, explored from the perspectives of peer counselors and network partners. Data sources are focus groups with peer counselors (implementation experience, role development, challenges in delivering counseling), semi-structured interviews with network partners (perceived fit within the care landscape, referral barriers, long-term integration and resource needs) and institutional documents (cantonal service agreement, annual reports, policy and funding decisions). Data are analyzed using Framework Analysis, with an initial coding frame based on known implementation barriers (role clarity, supervision, organizational embedding) and inductive coding of further themes. Findings are organized by RE-AIM dimensions.
Time frame: During the data collection period (approximately 12 months)
Client experience of peer counseling and perceived mechanisms of change
lients' subjective experience of counseling, perceived benefits and challenges, and their understanding of what contributed to any change, explored through semi-structured interviews (approximately 45-60 minutes) with approximately 10-12 clients after completion of counseling. The interview guide and initial coding frame are based on the CHIME framework of personal recovery (Connectedness, Hope and optimism, Identity, Meaning in life, Empowerment). Data are analyzed using Framework Analysis, combining deductive coding along CHIME dimensions with inductive identification of further themes.
Time frame: fter the final counseling session (one interview per participant)
Change in subjective recovery (Recovery Assessment Scale, German version, RAS-G)
Subjective personal recovery of clients, measured with the German version of the Recovery Assessment Scale. Items are rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree); higher scores indicate greater subjective recovery. Change between t0 and t1 is analyzed at group level using non-parametric tests and effect sizes (Cohen's d).
Time frame: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later
Change in positive mental health (Mental Health Continuum - Short Form, MHC-SF)
Emotional, social and psychological well-being of clients, measured with the Mental Health Continuum - Short Form (MHC-SF). The MHC-SF consists of 14 items rated on a 6-point frequency scale (0 = never to 5 = every day) referring to the past month. The total score ranges from 0 to 70; higher scores indicate greater positive mental health. Change between t0 and t1 is analyzed at group level using non-parametric tests and effect sizes (Cohen's d).
Time frame: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later
Change in perceived stress (Perceived Stress Questionnaire, PSQ-20)
Subjectively experienced stress of clients, measured with the German 20-item version of the Perceived Stress Questionnaire. Items cover four dimensions (worries, tension, joy, demands) and are rated on a 4-point scale (1 = almost never to 4 = mostly). Scores are transformed to a range of 0 to 100; higher scores indicate greater perceived stress. Change between t0 and t1 is analyzed at group level using non-parametric tests and effect sizes (Cohen's d).
Time frame: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later
Client satisfaction with the service (Client Satisfaction Questionnaire, ZUF-8)
Overall satisfaction of clients with the counseling received, measured with the ZUF-8, the German adaptation of the Client Satisfaction Questionnaire (CSQ-8). The ZUF-8 consists of 8 items rated on a 4-point scale. The total score ranges from 8 to 32; higher scores indicate greater satisfaction. Results are reported descriptively.
Time frame: After the last counseling session (t1
No study locations are listed for this record.
Plan to share: No — Anonymized quantitative data from the client surveys (RAS-G, MHC-SF, PSQ-20, ZUF-8) and the implementation surveys (AIM, IAM, FIM) underlying published results will be available from the corresponding author on reasonable request after completion of the study and publication of the main results. Qualitative data (interview and focus group transcripts) and data from peer counselors will not be shared, because the small sample sizes and the regional setting would make participants identifiable. Data will be shared for scientific purposes only, subject to a data use agreement.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 60 non-industry observational studies under Stress, Psychological, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 57. This study's planned 12 months is below that.
Counting every sponsor, half of 63 studies reached it within 23 months; a quarter within 6 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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St.Gallen University of Applied Sciences