Mental Health Disorder Clinical Trial
— PEEROfficial 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
NCT number | NCT04639167 |
Other study ID # | PEER |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 7, 2020 |
Est. completion date | June 26, 2023 |
Verified date | February 2024 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 299 |
Est. completion date | June 26, 2023 |
Est. primary completion date | March 3, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ยง82 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Centre Copenhagen | Copenhagen | Hellerup |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | The Peer partnership association |
Denmark,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | General Self-efficacy (GSE) | 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). | At end of intervention (3 months) | |
Other | The Self-advocacy scale (SAS) | 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). | At end of intervention (3 months) | |
Other | State Hope Scale (SHS) | 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). | At end of intervention (3 months) | |
Other | Copenhagen Social Relations Questionnaire (CSRQ) | 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. | At end of intervention (3 months) | |
Primary | 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 | 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) | At end of intervention (3 months) | |
Secondary | 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). | At end of intervention (3 months) | |
Secondary | 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). | At end of intervention (3 months) |
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