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Psychological DistressNCT07879443

A Community-based, Peer-led Counseling Service: A Hybrid Type 3 Effectiveness-implementation Study

An observational study of Psychological Distress and Stress Psychological, run by St.Gallen University of Applied Sciences.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

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Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
How many people
65 participants
Where
No sites listed yet
Study dates
Dec 2026to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • Age 18 to 65 years
  • Living in the canton of St. Gallen, Switzerland
  • Personally affected by a mental health problem or psychologically challenging situation
  • Admitted to counseling at Peerberatung St. Gallen through the regular intake process and received at least one counseling session during the 12-month data collection period
  • Informed consent
  • Additional inclusion criterion for interviews (Aim 2):
Show all 11Show fewer
  • Completed counseling (single session up to the full course of six sessions)
  • EX-IN-trained peer counselor actively delivering counseling at Peerberatung St. Gallen during the data collection period
  • Informed consent
  • Professional or organizational representative in the regional care network of Peerberatung St. Gallen, identified through the stakeholder analysis
  • Informed consent

Who cannot join

  • Not personally affected by a mental health problem (e.g. professionals or relatives/informal caregivers who use the service on behalf of others)
  • Not admitted to counseling at intake, i.e. persons who report suicidality, seek peer counseling as a substitute for clinical or psychiatric treatment, want to discuss treatment-specific questions such as medication, or seek support outside the scope of counseling (e.g. legal or financial assistance); these persons are referred to other services
  • Not actively delivering counseling at Peerberatung St. Gallen during the data collection period (e.g. extended leave or departure from the service)
  • Persons employed by or working for Peerberatung St. Gallen (peer counselors, project team, research team)
  • Persons without a professional or organizational role in the regional care network (e.g. private individuals)
  • Persons who use or have used the service as clients

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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:

Read more
  • Do clients report changes in their personal recovery, well-being and stress after using the service?
  • How do clients experience the counseling, and what do they find helpful?
  • How is the service put into practice, and how do peer counsellors and partner organizations view it?

Clients who use the service will:

  • Fill out an anonymous questionnaire at the start of counseling and again after their last session
  • Be invited to take part in an interview about their experience

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)
Read the detailed description

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.

Keywords
Peer Support, Peer counseling, lived expierence, recovery, Implementation Science, Hybrid effectiveness-implementation design, RE-AIM
Medical subject headings
Stress, Psychological, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07879443
Study groupRoleWhat they receive
ClientsAdults (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).
PeersAll 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).
Network partnersProfessionals 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Single assessment during the data collection period (approximately 12 months)

  2. 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.

    Measured: Single assessment during the data collection period (approximately 12 months)

  3. 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.

    Measured: Single assessment during the data collection period (approximately 12 months)

  4. 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.

    Measured: During the data collection period (approximately 12 months)

Secondary outcomes (5)
  1. 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.

    Measured: fter the final counseling session (one interview per participant)

  2. 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).

    Measured: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later

  3. 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).

    Measured: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later

  4. 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).

    Measured: Before the first counseling session (t0) and after the last counseling session (t1), typically 6 weeks to 6 months later

  5. 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.

    Measured: After the last counseling session (t1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
65 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07879443
Sponsor's protocol ID
2026-01040/01050
Status last verified
Oct 2026
First submitted
10 Oct 2026
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Psychological Distress and Stress Psychological, run by St.Gallen University of Applied Sciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolaj Sprecher (00 41 58 257 39 88, nicolaj.sprecher@ost.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the peer counseling service (Acceptability of Intervention Measure, AIM) (time frame: Single assessment during the data collection period (approximately 12 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

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