Knowledge, Attitudes, Practice Clinical Trial
Official title:
Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study
The goal of this one-arm pre-test/post-test study is to evaluate the feasibility and preliminary effect of a community-based psychoeducational group intervention for informal caregivers of individuals with mental illness. The main questions it aims to answer are: - What is the feasibility and acceptability of the intervention? - What is the preliminary effect of the intervention? Participants self-select to the intervention and participation in the evaluation is voluntary. Participants will be asked to: - Answer a questionnaire before and after their participation - Some participants will be invited for an in-depth interview There is no comparison group, but feasibility and acceptability will also be explored by asking the implementation team (e.g. project leaders and teachers) to participate in: - In-depth interviews - Answering shorter questionnaires about provider acceptability
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 1, 2027 |
Est. primary completion date | January 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Able to read, speak, and understand the Danish langugage - Relative/informal caregiver of an individual with a mental illness |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Involvement of Relatioves | Vejle |
Lead Sponsor | Collaborator |
---|---|
University of Southern Denmark | Mental Health Services, Region of Southern Denmark, OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark |
Denmark,
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Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144. — View Citation
Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Relationship satisfaction | Relationship satisfaction is measured using one item from the Couples Satisfaction Index. The question relates to the overall satisfaction with the relationship, and is measured on a 6-point Likert-Scale, ranging from 1 (not at all) to 6 (completely). Higher scores indicate higher satisfaction. | 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention). | |
Other | Self-reported teacher fidelity | To measure feasibility of the intervention, teacher adherence to the manual is measured. The teachers fill in a fidelity checklist, which consists of 4-6 items that measure the extent to which key components of the intervention were delivered. The questions are rated on a Likert-Scale ranging from 1 (not at all) to 3 (a lot). | through study completion, an average of 1 year | |
Primary | Recruitment rate | To measure the feasibility of the intervention, there is a measure of recruitment rate (number of participants recruited/time period in months). | Recruitment rate is monitored throughout the study period (1 year) | |
Primary | Attendance rate | To measure feasibility of the intervention, there is a measure of attendance rate: (number of participants attending/total number of enrolled participants) * 100 | Attendance rates are monitored throughout the study period (1 year) | |
Primary | Retention rate | To measure feasibility of the intervention, there is a measure of retention rate: (number of participants remaining/intital Number of Enrolled Participants) * 100 | Retention rates are monitored throughout the study period (1 year) | |
Primary | Satisfaction, quantitative measure | To measure acceptability of the intervention, participants' overall satisfaction with the program will be measured. This measure is based on 11 questions, that are rated on a 4-point Likert-Scale. Higher scores indicate higher satisfaction. | Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention). | |
Primary | Satisfaction, qualitative measure | To measure acceptability of the intervention, participants are invited to write about their experience with the program and their ideas for program development. | Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention). | |
Primary | Suitability, qualitative measure | Based on individual semi-structured interviews with some of the participants the investigators will evaluate whether the intervention fits the target population's needs, preferences, and cultural context. This measure will be used to assess whether any modifactions are needed to enhance the programme suitability. | Individual semi-structured interviews will be conducted throughout the study period (1 year). | |
Primary | Barriers and facilitators, qualitative measure (provider perspective) | Based on focus-group interviews with the teachers and other stakeholders, qualitative data will be collected to understand the providers' experiences, perceptions, and suggestions for improvement of the program. | Focus-group interviews will be conducted throughout the study period (1 year). | |
Secondary | Well-being: WHO-5 well-being index | The World Health Organisation- Five Well-Being Index (WHO-5) is a short self-reported measure of current mental wellbeing. It is composed of five questions that are rated on a 6-point Likert-Scale, where 5 = all the time and 0 = at no time. The raw score ranging from 0 to 25 is multiplied by 4 to give the final score from 0 (representing the worst imaginable well-being) to 100 (representing the best imaginable well-being). | 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention). | |
Secondary | Personal Burnout: Copenhagen Burnout Inventory (CBI; personal burnout) | The CBI consists of three inventories measuring 1) personal burnout, 2) work-related burnout, and 3) client-related burnout, for use in different domains. In this study, only the personal burnout inventory is used. The personal burnout inventory consists of six questions that are rated on a 5-point Likert-Scale ranging from 1 (never/almost never), 2 (seldom), 3 (sometimes), 4 (often), and 5 (always). Total score on the scale is the average of the scores on the items, and higher scores indicate higher levels of burnout. |
1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention). | |
Secondary | Coping: Brief resilient coping scale | The Brief Resilient Coping Scale captures tendencies to cope with stress adaptively. The scale focuses on the tendency to effectively use coping strategies in flexible, committed ways to actively solve problems despite stressful circumstances. The four items are rated on a 5-point Likert-Scale ranging from 1 (does not describe me at all) to 5 (describes me very well). Higher scores indicate more resilient coping. The score ranges from 4 - 20. Scores from 4-13 represent low resilient copers; scores from 14-16 represent medium resilient copers; and scores from 17-20 represent high resilient copers. | 1 week before the first session, and immediatly after the last session (session six, either 35 days or 70 days after enrolling in the intervention). |
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