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Clinical Trials/NCT06190262
NCT06190262CompletedNot Applicable

Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study

University of Southern Denmark2 sites in 1 country744 target enrollmentStarted: January 8, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
744
Locations
2
Primary Endpoint
Retention rate

Study Overview

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

Detailed Description

The program/intervention:

The group-based psychoeducational program focuses on enhancing informal caregivers' or relatives' understanding of their loved ones' mental illnesses and equips them with coping strategies. The main goal is to improve caregivers' knowledge of mental illnesses and their ability to navigate in their daily life/their role as an informal caregiver without becoming overburdened.

The specific program was collaboratively developed by a non-government organization and the regional psychiatry in one of Denmarks five Regions. Participants self-select to the program and participation is free of cost.

The program consists of six sessions, two of which are conducted online. The program is designed for groups of 16-20 individuals.

Session 1: The first session serves as an introduction to the program, where participants get acquainted with each other and familiarize themselves with the program's content. During this session, participants are encouraged to establish their own rules while also discussing the "Chatham House rules."

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Retention rate

Time Frame: Retention rates are monitored throughout the study period (1 year)

To measure feasibility of the intervention, there is a measure of retention rate: (number of participants remaining/intital Number of Enrolled Participants) \* 100

Recruitment rate

Time Frame: Recruitment rate is monitored throughout the study period (1 year)

To measure the feasibility of the intervention, there is a measure of recruitment rate (number of participants recruited/time period in months).

Barriers and facilitators, qualitative measure (provider perspective)

Time Frame: Focus-group interviews will be conducted throughout the study period (1 year).

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.

Satisfaction, quantitative measure

Time Frame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).

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.

Satisfaction, qualitative measure

Time Frame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).

To measure acceptability of the intervention, participants are invited to write about their experience with the program and their ideas for program development.

Suitability, qualitative measure

Time Frame: Individual semi-structured interviews will be conducted throughout the study period (1 year).

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.

Attendance rate

Time Frame: Attendance rates are monitored throughout the study period (1 year)

To measure feasibility of the intervention, there is a measure of attendance rate: (number of participants attending/total number of enrolled participants) \* 100

Secondary Outcomes

  • 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).)
  • 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).)
  • 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).)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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