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

Sponsor

Mental Health Centre Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT04639167

Collaborator

The Peer partnership association (Other)

284

Enrollment

Location

Arms

22.8

Anticipated Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mental Health Impairment Peer Group Mental Health Disorder Problems Psychosocial	Behavioral: Paths to everyday life (PEER)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

284 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 aloneA 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 (Investigator, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Dec 7, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	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.
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.

Arm

Intervention/Treatment

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.

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.

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.

Outcome Measures

Primary Outcome Measures

Questionnaire about the Process of Recovery (QPR-15) [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.

Secondary Outcome Measures

The Empowerment Scale, Rogers (ESR) [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) [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), [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).

Other Outcome Measures

General Self-efficacy (GSE) [At end of intervention (3 months)]
Self-efficacy is measured with the general self-efficacy scale (GSE), which consists of 10-items designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. The GSE scale is widely used and validated and is scored on a 4-point Likert scale ranging from 0 (not at all true) to 4 (exactly true).
The Self-advocacy scale (SAS) [At end of intervention (3 months)]
Self-advocacy is measured with the self-advocacy scale (SAS), which consists of 8-items involving taking care of yourself, being organized and prepared, finding the resources you need, and communicating and negotiating to get your needs met. The SAS scale is only used and validated in research about acquired brain injury and scored on a 4-point Likert scale ranging from 0 (not confident) to 4 (very confident).
State Hope Scale (SHS) [At end of intervention (3 months)]
Hope is measured with the State Hope Scale (SHS), which consist of 6-items measuring hope ie the belief in one's own ability to initiate and maintain actions and ways to achieve goals. The state hope scale is widely used and validated and scored on an 8-point scale ranging from 1 (definitely false) to 8 (definitely true).
Copenhagen Social Relations Questionnaire (CSRQ) [At end of intervention (3 months)]
Social network is measured with a modified version of the Copenhagen Social Relations Questionnaire (CSRQ), which consist of 19-items covering frequency of social contact, social support in everyday life, quality of social relations and frequency of participating in local social activities. The questionnaire has satisfactory validity and reliability and is widely used in Danish population surveys.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion criteria:

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.