Clinical trial NCT06190262: Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness
Official title: Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Caregiver Burnout
Well-Being, Psychological
Coping Strategies
Knowledge, Attitudes, Practice
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: OPEN, Open Patient data Explorative Network, Odense University Hospital, Region of Southern Denmark
First posted: 2024-01-05
Enrollment: 744
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One arm pre-test/post-test design.
Primary purpose: HEALTH_SERVICES_RESEARCH

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."

Session 2: Moving on to the second session, the focus is on disseminating knowledge about mental illnesses, treatment, and the distinctions between regional psychiatry and community-based treatments. A compassion-focused exercise is also included during this session.

Session 3: The third session centers on providing information about various treatment opportunities, exploring different types of treatment in addition to medication and talk therapy. Moreover, participants gain insights into how they can be involved in the treatment process if the patient provides their consent. This session is conducted online.

Session 4: The fourth session delves into the caregiver role and self-care strategies. Participants are introduced to different coping-strategies.

Session 5: In the fifth session, the focus shifts to the rights of the participants, such as their entitlement to care days and information about other caregiver interventions in the community. This session is conducted online.

Session 6: Finally, in the last session, all the topics covered throughout the program are summarized, and support groups are established to provide ongoing assistance and encouragement.

In 2024, around 24 courses will be offered, each spanning a duration of 35-70 days. The sessions will be conducted. The sessions will be scheduled either weekly (with 6 sessions over a 35-day period) or bi-weekly (with 6 sessions over a 70-day period).

The evaluation:

All participants in the program will be asked to participate in the evaluation. Participation in the evaluation is completely voluntary.

The primary purpose of the evaluation is to use the results of the evaluation to continuously revise the program to reflect the needs of the participants. By the end of 2025, the program will have undergone the last revision, and be ready to move on to a full evaluation using a RCT design. Thus, in line with guidance from the UK Medical Council Research Framework (MRC) and the National Institute of Health Research framework, the present study is an initial step in determining if the developed intervention is feasible and acceptable for relatives to individuals with mental illness. A mixed-methods approach was chosen to explore indications of participants' response and view to the intervention and thereby gain a more full understanding of the intervention acceptability and feasibility.

The principal aims of this study are as follows:

1. To assess the feasibility and acceptability of the intervention, the investigators aim to:

   1. Quantify recruitment rate and attendance rate
   2. Measure participants' satisfaction with the intervention
   3. Qualitatively explore participants satisfaction and their ideas for development
   4. By using purposeful sampling strategies, some participants will be invited to take part in an in-depth interview about their experience with the program and about their perspective on facilitators and barriers of the intervention. They will also be asked about how to improve the program in the future.
2. To assess the preliminary effectiveness of the intervention, participants are asked to:

   1. Self-report on their well-being before and after the intervention
   2. Self-report on their level of burnout before and after the intervention
   3. Self-report on their level of resilient coping before and after the intervention

   This evidence will provide an initial indication of whether the intervention can contribute to change within this group. Estimated effect sizes will provide the parameters for a definitive randomized controlled trial. Data will be explored using the reliable and clinically significant change analysis. This analysis allows pre- and post-treatment scores to be compared to see if participants have achieved a level of difference that could be categorized as real and not due to measurement error. Furthermore this score can be helpful to determine if the change seen is clinically significant.
3. To assess feasibility and acceptability from the providers, the investigators aim to:

   1. Conduct in-depth interviews with members of the implementation teams (such as project leaders and teachers in the program).

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: Recruitment rate is monitored throughout the study period (1 year)
measure: Attendance rate
timeFrame: Attendance rates are monitored throughout the study period (1 year)
measure: Retention rate
timeFrame: Retention rates are monitored throughout the study period (1 year)
measure: Satisfaction, quantitative measure
timeFrame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
measure: Satisfaction, qualitative measure
timeFrame: Immediatly after participants finish the last session (session six, either 35 days or 70 days after enrolling in the intervention).
measure: Suitability, qualitative measure
timeFrame: Individual semi-structured interviews will be conducted throughout the study period (1 year).
measure: Barriers and facilitators, qualitative measure (provider perspective)
timeFrame: Focus-group interviews will be conducted throughout the study period (1 year).
Secondary outcomes:
measure: Well-being: WHO-5 well-being index
timeFrame: 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).
measure: Personal Burnout: Copenhagen Burnout Inventory (CBI; personal burnout)
timeFrame: 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).
measure: Coping: Brief resilient coping scale
timeFrame: 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:
measure: Relationship satisfaction
timeFrame: 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).
measure: Self-reported teacher fidelity
timeFrame: through study completion, an average of 1 year
Locations:
city: Vejle
country: Denmark
facility: Center for Involvement of Relatioves
Study officials:
affiliation: Department of Regional Health Research, University of Southern Denmark
name: Rikke Amalie Agergaard Jensen, Ph.d.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.
citation: 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.