NCT04639167

Brief Summary

The aim of this randomized, two-arm, investigator initiated, multi municipal, parallel-group superiority trial is to compare the effect on self-reported personal recovery of the following interventions: (1) 10-week group-based peer support intervention "Paths to everyday life" (PEER) added to service as usual (SAU); and (2) SAU alone. The primary outcome is self-reported personal recovery at end of intervention. Secondary and exploratory measures include empowerment, quality of life, functioning, hope, self-efficacy, self-advocacy and social network. The investigators, hypothesize that the superiority of the PEER intervention will be applicable for secondary outcomes and exploratory measures at end of intervention so that improvement in empowerment, hope, self-efficacy, self-advocacy, social network, quality of life and functioning will be improved among participants allocated to the PEER intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
17 days until next milestone

Study Start

First participant enrolled

December 7, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

2.2 years

First QC Date

November 13, 2020

Last Update Submit

February 2, 2026

Conditions

Keywords

Peer supportCommunity-basedRandomized Controlled TrialIndividual companionshipVolunteer peersPeer group sessions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire about the Process of Recovery (QPR-15)

    Personal recovery is measured with the Questionnaire about Process of Recovery (QPR-15), which consist of 15 items measuring aspects of personal recovery i.e. experiences of connectedness, hope, identity, meaning and empowerment - based on mental health consumer experiences of recovery. In psychometric evaluations, QPR-15 demonstrated good internal consistency and test-retest reliability, as well sufficient convergent validity and moderate sensitivity to change. Each item is scored on a 5-point Likert scale ranging from 0 (strongly disagree) to 5 (strongly agree) and gives a total score between 0-60.

    At end of intervention (3 months)

Secondary Outcomes (3)

  • The Empowerment Scale, Rogers (ESR)

    At end of intervention (3 months)

  • The Manchester Short Assessment of Quality of life (MANSA)

    At end of intervention (3 months)

  • Work and Social Adjusment Scale (WSAS),

    At end of intervention (3 months)

Other Outcomes (4)

  • General Self-efficacy (GSE)

    At end of intervention (3 months)

  • The Self-advocacy scale (SAS)

    At end of intervention (3 months)

  • State Hope Scale (SHS)

    At end of intervention (3 months)

  • +1 more other outcomes

Study Arms (2)

Paths to everyday life (PEER)

EXPERIMENTAL

The Paths to everyday life (PEER) intervention added to service as usual (SAU) consists of a 10-week group course and an opportunity of individual companionship to persons with mental vulnerability and mental health difficulties. The 10 week group sessions is facilitated by two volunteer peers with their own lived experiences with mental vulnerability.

Behavioral: Paths to everyday life (PEER)

Service as usual (SAU)

NO INTERVENTION

Participants who will be allocated to the control group of the trial will receive service as usual (SAU) by their social security officer, or no specific service if the participant has been referred to the trial by self-referral. Participants who are referred to the trial via §82 in the municipality, can receive other §82 offers depending on the individual municipality.

Interventions

The intervention consists of a 10-week group course and the opportunity of individual companionship to e.g. local activities in civil society, municipal social services, education, health and employment. The 10-week group sessions are delivered by two volunteer peers with their own experiential knowledge of mental vulnerability and mental health difficulties. The aim is to form a constructive community through group sessions where exchanges of lived experiences, mutuality and opportunities for social network development can develop.

Paths to everyday life (PEER)

Eligibility Criteria

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

You may qualify if:

  • Citizens using the municipal social service in the participating municipalities for support and assistance due to mental vulnerability and mental health difficulties, corresponding to the target group for §82 in the law of social service - i.e. citizens diagnosed with a mental illness and/or who is affected by mental dissatisfaction to a degree that limits the unfolding of life. Additionally, citizens who self-refer to the trial with similar mental health challenges.
  • Are residents of collaborating municipalities at baseline.
  • Can understand, speak, and read Danish.
  • Are aged 18 years or older.
  • Have given verbal and written consent to participate in the trial.

You may not qualify if:

  • Citizens intoxicated by alcohol and/or other substances - if they according to the local coordinator's judgment cannot participate in the peer group, they are advised to contact professional help.
  • Citizens with specific suicide plans - if they according to the local coordinator's judgment cannot participate in the peer group, they are advised to contact professional help.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Hellerup, 3900, Denmark

Location

Related Publications (25)

  • Pitt V, Lowe D, Hill S, Prictor M, Hetrick SE, Ryan R, Berends L. Consumer-providers of care for adult clients of statutory mental health services. Cochrane Database Syst Rev. 2013 Mar 28;2013(3):CD004807. doi: 10.1002/14651858.CD004807.pub2.

    PMID: 23543537BACKGROUND
  • Fuhr DC, Salisbury TT, De Silva MJ, Atif N, van Ginneken N, Rahman A, Patel V. Effectiveness of peer-delivered interventions for severe mental illness and depression on clinical and psychosocial outcomes: a systematic review and meta-analysis. Soc Psychiatry Psychiatr Epidemiol. 2014 Nov;49(11):1691-702. doi: 10.1007/s00127-014-0857-5. Epub 2014 Mar 17.

    PMID: 24632847BACKGROUND
  • Lloyd-Evans B, Mayo-Wilson E, Harrison B, Istead H, Brown E, Pilling S, Johnson S, Kendall T. A systematic review and meta-analysis of randomised controlled trials of peer support for people with severe mental illness. BMC Psychiatry. 2014 Feb 14;14:39. doi: 10.1186/1471-244X-14-39.

    PMID: 24528545BACKGROUND
  • Gillard S, Gibson SL, Holley J, Lucock M. Developing a change model for peer worker interventions in mental health services: a qualitative research study. Epidemiol Psychiatr Sci. 2015 Oct;24(5):435-45. doi: 10.1017/S2045796014000407. Epub 2014 Jul 3.

    PMID: 24992284BACKGROUND
  • Repper J, Carter T. A review of the literature on peer support in mental health services. J Ment Health. 2011 Aug;20(4):392-411. doi: 10.3109/09638237.2011.583947.

    PMID: 21770786BACKGROUND
  • Walker G, Bryant W. Peer support in adult mental health services: a metasynthesis of qualitative findings. Psychiatr Rehabil J. 2013 Mar;36(1):28-34. doi: 10.1037/h0094744.

    PMID: 23477647BACKGROUND
  • Williams J, Leamy M, Pesola F, Bird V, Le Boutillier C, Slade M. Psychometric evaluation of the Questionnaire about the Process of Recovery (QPR). Br J Psychiatry. 2015 Dec;207(6):551-5. doi: 10.1192/bjp.bp.114.161695. Epub 2015 Oct 8.

    PMID: 26450585BACKGROUND
  • Chien WT, Clifton AV, Zhao S, Lui S. Peer support for people with schizophrenia or other serious mental illness. Cochrane Database Syst Rev. 2019 Apr 4;4(4):CD010880. doi: 10.1002/14651858.CD010880.pub2.

    PMID: 30946482BACKGROUND
  • Leamy M, Bird V, Le Boutillier C, Williams J, Slade M. Conceptual framework for personal recovery in mental health: systematic review and narrative synthesis. Br J Psychiatry. 2011 Dec;199(6):445-52. doi: 10.1192/bjp.bp.110.083733.

    PMID: 22130746BACKGROUND
  • Law H, Neil ST, Dunn G, Morrison AP. Psychometric properties of the questionnaire about the process of recovery (QPR). Schizophr Res. 2014 Jul;156(2-3):184-9. doi: 10.1016/j.schres.2014.04.011. Epub 2014 May 9.

    PMID: 24816049BACKGROUND
  • Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.

    PMID: 9255837BACKGROUND
  • Rogers ES, Ralph RO, Salzer MS. Validating the empowerment scale with a multisite sample of consumers of mental health services. Psychiatr Serv. 2010 Sep;61(9):933-6. doi: 10.1176/ps.2010.61.9.933.

    PMID: 20810594BACKGROUND
  • Bjorkman T, Svensson B. Quality of life in people with severe mental illness. Reliability and validity of the Manchester Short Assessment of Quality of Life (MANSA). Nord J Psychiatry. 2005;59(4):302-6. doi: 10.1080/08039480500213733.

    PMID: 16195135BACKGROUND
  • Priebe S, Huxley P, Knight S, Evans S. Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry. 1999 Spring;45(1):7-12. doi: 10.1177/002076409904500102.

    PMID: 10443245BACKGROUND
  • Thandi G, Fear NT, Chalder T. A comparison of the Work and Social Adjustment Scale (WSAS) across different patient populations using Rasch analysis and exploratory factor analysis. J Psychosom Res. 2017 Jan;92:45-48. doi: 10.1016/j.jpsychores.2016.11.009. Epub 2016 Nov 30.

    PMID: 27998511BACKGROUND
  • Luszczynska A, Scholz U, Schwarzer R. The general self-efficacy scale: multicultural validation studies. J Psychol. 2005 Sep;139(5):439-57. doi: 10.3200/JRLP.139.5.439-457.

    PMID: 16285214BACKGROUND
  • Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.

    PMID: 8636885BACKGROUND
  • Hawley L, Gerber D, Pretz C, Morey C, Whiteneck G. Initial validation of personal self-advocacy measures for individuals with acquired brain injury. Rehabil Psychol. 2016 Aug;61(3):308-316. doi: 10.1037/rep0000093. Epub 2016 May 12.

    PMID: 27177213BACKGROUND
  • Lund R, Nielsen LS, Henriksen PW, Schmidt L, Avlund K, Christensen U. Content validity and reliability of the Copenhagen social relations questionnaire. J Aging Health. 2014 Feb;26(1):128-50. doi: 10.1177/0898264313510033.

    PMID: 24584264BACKGROUND
  • Deegan PE. The lived experience of using psychiatric medication in the recovery process and a shared decision-making program to support it. Psychiatr Rehabil J. 2007 Summer;31(1):62-9. doi: 10.2975/31.1.2007.62.69.

    PMID: 17694717BACKGROUND
  • Anthony WA. Recovery from mental illness: The guiding vision of the mental health service system in the 1990s. Psychosoc Rehabil J. 1993;16(4):11-23.

    BACKGROUND
  • Poulsen CH, Egmose CH, Ebersbach BK, Hjorthoj C, Eplov LF. A community-based peer-support group intervention "Paths to EvERyday life" (PEER) added to service as usual for adults with vulnerability to mental health difficulties - a study protocol for a randomized controlled trial. Trials. 2022 Sep 2;23(1):727. doi: 10.1186/s13063-022-06670-6.

    PMID: 36056407BACKGROUND
  • Poulsen CH, Egmose CH, Ebersbach B, Hjorthoj C, Eplov LF. The "Paths to everyday life" peer support intervention for adults with mental health difficulties versus service as usual in a Danish community setting - results from a randomized two-armed, multi-site, superiority trial. BMC Psychiatry. 2025 Jul 11;25(1):695. doi: 10.1186/s12888-025-07011-y.

  • Poulsen CH, Egmose CH, Bjorkedal SB, Eplov LF. Intervention delivery in the 'Paths to everyday life' (PEER) trial: a qualitative study of the perspectives of the peer volunteers with lived experiences of being in personal recovery of mental health difficulties. BMC Psychiatry. 2025 Jul 2;25(1):671. doi: 10.1186/s12888-025-06982-2.

  • Egmose CH, Poulsen CH, Bjorkedal SB, Eplov LF. The 'Paths to everyday life' (PEER) trial - a qualitative study of mechanisms of change from the perspectives of individuals with mental health difficulties participating in peer support groups led by volunteer peers. BMC Psychiatry. 2024 Aug 13;24(1):555. doi: 10.1186/s12888-024-05992-w.

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Lene F Eplov, MD PhD

    Mental Health Center Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participants, the local coordinators and the volunteer peers cannot be blinded to the group allocation. The REDCap randomization tool will be used to facilitate randomization. To ensure concealment, the randomization schedule is stored away from the research team and the block sizes are not disclosed. The allocation is performed by a not-blinded research coordinator, who informs the participants allocated to the control group through a central telephone. Moreover, the research coordinator informs the local coordinators in each municipality about participants allocated to the intervention group through submitting the record id via secure email. The local coordinators will be able to identify the participants through their access to REDCap. The researchers will be blinded to group allocation during the process of data analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A randomized, two-arm, investigator initiated, multi municipal, parallel-group superiority trial comparing the effect on self-reported personal recovery of the following interventions: (1) 10-week group-based peer support intervention "Paths to everyday life" (PEER) added to servide as usual (SAU) and (2) SAU alone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Research, Associate professor

Study Record Dates

First Submitted

November 13, 2020

First Posted

November 20, 2020

Study Start

December 7, 2020

Primary Completion

March 3, 2023

Study Completion

June 26, 2023

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The individual participant data that support the findings in this article will be made available after de-identification, along with the statistical analysis plan, upon reasonable request from researchers who provide a methodologically sound proposal. To request access, proposals should be directed to the corresponding author. Data requestors will need to sign a data access agreement to gain access to the data. The register-based data cannot be provided on request because it is hosted by Statistics Denmark. The data was only accessible to researchers connected to the project, and it was not possible to download the final trial data set.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The data will be available in 5 years from publication of the results.
Access Criteria
To request access, proposals should be directed to the corresponding author. Data requestors will need to sign a data access agreement to gain access to the data.

Locations