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

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ClinicalTrials.gov Identifier: NCT04639167
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
The Peer partnership association
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 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 : December 7, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. 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).


Other Outcome Measures:
  1. General Self-efficacy (GSE) [ Time Frame: 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).

  2. The Self-advocacy scale (SAS) [ Time Frame: 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).

  3. State Hope Scale (SHS) [ Time Frame: 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).

  4. Copenhagen Social Relations Questionnaire (CSRQ) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Citizens using the municipal social service in Fredericia, Elsinore and Copenhagen, respectively 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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639167


Contacts
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Contact: Chalotte H Poulsen, MSc PhD 0045 51583780 chalotte.heinsvig.poulsen.01@regionh.dk
Contact: Cecilie H Egmose, Msc 0045 51583780 cecilie.hoegh.egmose.01@regionh.dk

Locations
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Denmark
Mental Health Centre Copenhagen Recruiting
Copenhagen, Hellerup, Denmark, 3900
Contact: Lene F Eplov, MD, PhD    0045 38647461    lene.falgaard.eplov@regionh.dk   
Contact: Bea K Ebersbach    0045 2334 9551    bea.marie.kolbe.ebersbach@regionh.dk   
Sponsors and Collaborators
Mental Health Centre Copenhagen
The Peer partnership association
Investigators
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Principal Investigator: Lene F Eplov, MD PhD Mental Health Center Copenhagen
Publications:
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.

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Responsible Party: Lene Falgaard Eplov, Senior consultant, PhD, Head of research program Recovery and Inclusion, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT04639167    
Other Study ID Numbers: PEER
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lene Falgaard Eplov, Mental Health Centre Copenhagen:
Peer support
Community-based
Randomized Controlled Trial
Individual companionship
Volunteer peers
Peer group sessions
Additional relevant MeSH terms:
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Mental Disorders