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.
Full Title of Study: “An Early Community-based Peer-support Intervention “Paths to Everyday Life” (PEER) Added to Service as Usual to Adult People With Mental Vulnerability and Mental Health Difficulties – a Study Protocol for a Randomized Controlled Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Prevention
- Masking: Double (Investigator, Outcomes Assessor)
- Study Primary Completion Date: May 2022
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.
- Behavioral: Paths to everyday life (PEER)
- 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.
Arms, Groups and Cohorts
- Experimental: Paths to everyday life (PEER)
- 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.
- No Intervention: Service as usual (SAU)
- 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.
Clinical Trial Outcome Measures
- Questionnaire about the Process of Recovery (QPR-15)
- Time Frame: At end of intervention (3 months)
- 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.
- The Empowerment Scale, Rogers (ESR)
- Time Frame: At end of intervention (3 months)
- 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)
- The Manchester Short Assessment of Quality of life (MANSA)
- Time Frame: At end of intervention (3 months)
- 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).
- Work and Social Adjusment Scale (WSAS),
- Time Frame: At end of intervention (3 months)
- 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).
Participating in This Clinical Trial
1. 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. 2. 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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Mental Health Centre Copenhagen
- The Peer partnership association
- Provider of Information About this Clinical Study
- Principal Investigator: Lene Falgaard Eplov, Senior consultant, PhD, Head of research program Recovery and Inclusion – Mental Health Centre Copenhagen
- Overall Official(s)
- Lene F Eplov, MD PhD, Principal Investigator, Mental Health Center Copenhagen
- Overall Contact(s)
- Chalotte H Poulsen, MSc PhD, 0045 51583780, email@example.com
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