NCT07407842

Brief Summary

Research problem and specific questions Peer support (PS) is a well-established intervention within community mental health services (CMHS) internationally, involving a person recovering from serious mental health problems (SMHP) in supporting other users. International studies have shown that PS strengthen users recovery and social inclusion but also highlight the need for larger effect studies on specific manualized interventions. Despite international research showing benefits of PS in C MHS, PS an underused type of support in Sweden. There is a urgent need for more Swedish research developing and evaluating the efficacy of PS interventions for persons recovering from SMHP and in shifting Swedish MHS towards a recovery focused model of service. In meeting this need the current project aims to evaluate the efficacy of a new manualized PS intervention, the UPSIDES-Swe, in Swedish MHS. Is the peer support intervention, UPSIDES-Swe, significantly more effective than TAU at intervention end (10 weeks) in terms of personal recovery (primary outcome)? Is UPSIDES-Swe significantly more effective than TAU post intervention and at three month followups in terms of other personal recovery aspects (secondary outcomes i.e., social inclusion, empowerment, quality of life)? Is the UPSIDES-Swe, significantly more effective than TAU post intervention and at three followups in improving secondary outcomes of clinical recovery related variables, i.e., symptoms and functioning? How well can the implementation plan and UPSIDES-Swe intervention be implemented and processes explained in relation to primary and secondary outcomes? Data and method A randomized, assessor-blinded, multi-center trial will be performed between the years 2025-2028. A total of 300 service users will be recruited, and half will be randomized to receiving a PS intervention (UPSIDES-Swe) and an equal number to TAU. A process evaluation will also be performed. Societal relevance and utilization This project will investigate if a specific PS intervention might be effective in providing greater recovery and social inclusion for a disadvantaged and largely neglected group. The Swedish National Board of Health and Welfare has also recommended that PS is a promising method but that the evidence is weak and that all implementation of PS interventions should be evaluated.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Nov 2025Nov 2028

Study Start

First participant enrolled

November 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

February 6, 2026

Last Update Submit

March 14, 2026

Conditions

Keywords

Peer support

Outcome Measures

Primary Outcomes (1)

  • Personal recovery

    The Questionnaire about the Process of Recovery (QPR) (Argentzell et al Measuring personal recovery - psychometric properties of the Swedish Process of Recovery Questionnaire (QPR-Swe). Nordic J Psych. 2017; 71:7, 529-535). The QPR consists of 16 items, all rated on a five point scale (0 = does not apply at all, 1 = does not apply, 2 = neither nor, 3 = applies, 4 = fully applies). Higher scores indicate a higher degree of recovery.

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

Secondary Outcomes (5)

  • Social Inclusion

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

  • Quality of life measure

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

  • Empowerment

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

  • Symptoms

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

  • Function

    Before intervention, post intervention (at 10 weeks), 3 months post intervention

Study Arms (2)

UPSIDES-Swe

EXPERIMENTAL
Other: UPSIDES-Swe

TAU

NO INTERVENTION

Interventions

Peer support study circle

Also known as: TAU
UPSIDES-Swe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible participants must reside in Sweden and be assigned to a MHS. Other criteria are a) being over 18 of age and b) having SMHP (including a diagnosis of mood disorder, anxiety disorder, e.g., PTSD, panic disorder etc., and/or psychotic disorder).

You may not qualify if:

  • Potential participants will be excluded if they are acutely unwell or cognitively impaired to an extent that they cannot make an informed decision and/or participate in the group program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Region Skåne

Lund, Sweden

Location

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 12, 2026

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations