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Mental Health ImpairmentPEERNCT04639167

Paths to Everyday Life (PEER) - a Community-based Peer Support Intervention

A study testing Paths to everyday life (PEER) in people with Mental Health Impairment and Peer Group, run by Amager Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Paths to everyday life (PEER)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
299 participants
Where
1 siteDenmark
Study dates
7 Dec 2020to 26 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Mental Health Centre Copenhagen

    Copenhagen, Hellerup, 3900

Other trials in Denmark

About this study

Official title: Volunteer-led "Paths to Everyday Life" (PEER) Peer Support Group Intervention to Adults With Mental Health Difficulties Versus Service as Usual in the Community - Results From a Randomized Two-armed, Multi-municipal, Superiority Trial

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.

Read the detailed description

The "Paths to everyday life" (PEER) intervention is a newly developed community-based peer support intervention targeting persons with mental vulnerability and mental health difficulties. The development of the PEER intervention is conducted in a collaboration between the Peer partnership association and the Copenhagen Research Center for Mental Health (CORE), Recovery \& Inclusion, Mental Health Center Copenhagen.

The PEER intervention is inspired from: Peer support groups in the MIND Leeds organization; Manuals for peer support services and peer training, which has shown positive effect on measures of personal recovery in RCTs; Practical guides to everyday life developed by consumers of mental health treatment in Denmark; and lived experiences of mental illness and recovery within the project group. The content of the ten group sessions is developed from themes identified in the CHIME (Connectedness; Hope; Identity; Meaning; Empowerment) framework as promoting the personal recovery process, as well as knowledge from systematic reviews and meta-analyses in the field focusing on the effect of peer support. The entire PEER intervention is described in a comprehensive manual and detailed instructions have been prepared for the volunteer peers to make it accessible and ensure similarity across the groups. The manual of the PEER intervention has been further developed in a pilot study of the 10 week group sessions in a qualitative evaluation (N=25) in the period Feb.-Sept. 2020 in the collaborative municipalities Copenhagen, Elsinore and Fredericia.

The PEER 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. It is mandatory for the participants to participate in an introductory meeting with the purpose of informing about the group process, the individual companionship and the RCT, so that participation in the intervention becomes the participants' own informed choice. The group sessions are delivered by two volunteer peers with their own experiental knowledge of mental vulnerability and personal recovery. The volunteer peers must complete a basic peer education to facilitate the group course and enter individual companionship. A fidelity scale is developed and used for biannual fidelity reviews to ensure intervention program adherence and continuous focus on program implementation and improvement.

The overall purpose of the PEER intervention is to find a way to live life in a meaningful, energizing way - despite still finding some things challenging. The aim is to form a constructive community through group sessions where exchanges of lived experiences, mutuality and opportunities for social network development can form. The investigators hypothesize, that the volunteer peers by sharing their own experiences with mental vulnerability and personal recovery can create trust and inspire the participants to safely share their own experiences. Additionally, that the volunteer peers by presenting group themes and by participating on an equal footing with the participants in the group exercises can contribute to the participants' experience of connectedness with others, as well as promote the participants self-esteem and belief in possibilities, dreams and aspirations to regain meaning in life circumstances, control and responsibility for own life.

The PEER intervention will be evaluated in a two armed randomized controlled trial. The primary hypothesis for the trial is that participants allocated to the PEER intervention added to service as usual (SAU) gain a significantly increased experience of self-reported personal recovery at end of intervention than participants who are allocated to SAU alone.

The PEER intervention is not expected to have any severe side effects. However, when trial recruitment and the intervention phase has ended, safety measures i.e. number of somatic and psychiatric hospitalization days, death, suicide and probable self-harm is obtained from the Danish central registers to examine any severe adverse effects during the intervention period.

The sample size and power calculations was conducted using PS Power and Sample Size Calculations software. With an allocation ratio of 1:1 and a minimum clinically relevant difference of 5, a power of 80% and a significance level of 0.05%, we need 284 participants, i.e. 142 in the intervention group and 142 in the control group in order to reject the null hypothesis that self-assessed personal recovery is equal in the control group and the PEER group. Data analyzes will be based on the intention-to-treat principle i.e. that data from all participants will be included corresponding to the group to which the participants have been allocated. In case of missing data, multiple multivariate imputations will be used.

Being tested
Paths to everyday life (PEER)
Keywords
Peer support, Community-based, Randomized Controlled Trial, Individual companionship, Volunteer peers, Peer group sessions
Medical subject headings
Mental Disorders

What participants receive

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

  • Paths to everyday life (PEER)Behavioural

    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.

Study groups in NCT04639167
Study groupRoleWhat they receive
Paths to everyday life (PEER)ExperimentalThe 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.
Receives: Behavioral: Paths to everyday life (PEER)
Service as usual (SAU)No interventionParticipants 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.

What is being measured

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

  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.

    Measured: At end of intervention (3 months)

Secondary outcomes (3)
  1. The Empowerment Scale, Rogers (ESR)

    Empowerment is measured with The Empowerment scale Rogers (ESR), which consist of 28 items measuring a person's resources, opportunities and sense of control over their own life - based on mental health consumer experiences of empowerment. The Empowerment scale is widely used and validated and is scored on a 4-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree)

    Measured: At end of intervention (3 months)

  2. The Manchester Short Assessment of Quality of life (MANSA)

    Quality of life is measured with The Manchester Short Assessment of Quality of life (MANSA), which consist of 16 items whereas 4 items measure objective quality of life (close relationships, contact with friends, crime and assault) and 12 items measure subjective quality of life (satisfaction with life as a whole, work, financial situation, friendships, leisure activities, housing, personal safety/security, cohabitation, sex life, family relationships and health). The questionnaire has been validated and is scored on a 7-point scale ranging from 1 (couldn't be worse) to 7 (couldn't be better).

    Measured: At end of intervention (3 months)

  3. Work and Social Adjusment Scale (WSAS),

    Functioning is measured with the Work and Social Adjusment Scale (WSAS), which is a 5-item self-reported questionnaire covering a person's perceived functioning in terms of the domains 1) Workability; 2) Performing tasks at home (cleaning, shopping, paying bills, etc.); 3) Social leisure activities (parties, dating, tours, visits, cinema, etc.); 4) private leisure activities (reading, gardening, sewing, walking alone, etc.) and; 5) Ability to form and maintain close relationships. The questionnaire is widely used and validated and scored on an 8-point scale ranging from 0 (not at all) to 8 (very seriously).

    Measured: At end of intervention (3 months)

Timeline

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

  1. First posted20 Nov 2020
  2. Study start7 Dec 2020
  3. Primary completion3 Mar 2023
  4. Study completion26 Jun 2023

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04639167
Sponsor's protocol ID
PEER
Acronym
PEER
Status last verified
Feb 2026
First submitted
13 Nov 2020
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 23543537
  • 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.

    PubMed 24632847
  • 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.

    PubMed 24528545
  • 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.

    PubMed 24992284
  • 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.

    PubMed 21770786
  • 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.

    PubMed 23477647
  • 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.

    PubMed 26450585
  • 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.

    PubMed 30946482
  • 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.

    PubMed 22130746
  • 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.

    PubMed 24816049
  • 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.

    PubMed 9255837
  • 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.

    PubMed 20810594
  • 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.

    PubMed 16195135
  • 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.

    PubMed 10443245
  • 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.

    PubMed 27998511

Questions about this trial

What is this clinical trial studying?

A study testing Paths to everyday life (PEER) in people with Mental Health Impairment and Peer Group, run by Amager Hospital at 1 site in Denmark.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Questionnaire about the Process of Recovery (QPR-15) (time frame: At end of intervention (3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04639167, which also lists 25 linked publications.

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 4 Feb 2026.

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