Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness

NCT06190262 | Completed

• 4 other identifiers: OP_1919S-20232000 - 6623/2550223/70733
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Caregiver Burden; Caregiver Burnout; Well-Being, Psychological; Coping Strategies; Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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).

• 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).

• 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).

• 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 Outcomes (3)

• Well-being: WHO-5 well-being index

  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).

• Personal Burnout: Copenhagen Burnout Inventory (CBI; personal 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).

• Coping: Brief resilient coping scale

  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 Outcomes (2)

• Relationship 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).

• Self-reported teacher fidelity

  through study completion, an average of 1 year

Study Arms (1)

Psychoeducation

EXPERIMENTAL

The experimental condition consists of a psychoeducation program with six sessions. Two of the sessions are online. A teacher and a volunteer will lead the sessions. The topic of the sessions are diverse and cover topics such as mental illness, the diathesis-stress model, treatment of mental illness, caregiver coping mechanisms and caregiver rights. Before the first session, participants are asked to fill in an online questionnaire with background information and well-being indicators. After the last session, participants are asked to fill in another short questionnaire with the same well-being indicators and also a measure of their satisfaction with the program.

Behavioral: The intervention is community based group psychoeducation

Interventions

The intervention is community based group psychoeducation BEHAVIORAL

The intervention is community based group psychoeducation

Psychoeducation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able to read, speak, and understand the Danish langugage
• Relative/informal caregiver of an individual with a mental illness

Sponsors & Collaborators

• University of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark: collaborator

Study Sites (1)

Center for Involvement of Relatioves

Vejle, 7100, Denmark

Location

Related Publications (4)

• 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.

  PMID: 14994958 BACKGROUND

• 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.

  PMID: 25831962 BACKGROUND

• Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.

  PMID: 18179329 BACKGROUND

• Morley S, Williams A, Hussain S. Estimating the clinical effectiveness of cognitive behavioural therapy in the clinic: evaluation of a CBT informed pain management programme. Pain. 2008 Jul 31;137(3):670-680. doi: 10.1016/j.pain.2008.02.025. Epub 2008 Apr 3.

  PMID: 18394806 BACKGROUND

MeSH Terms

Conditions

Caregiver Burden; Psychological Well-Being; Behavior

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Personal Satisfaction

Study Officials

• Rikke Amalie Agergaard Jensen, Ph.d.

  Department of Regional Health Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One arm pre-test/post-test design.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: January 5, 2024
• Study Start: January 8, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)