Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06190262
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2023-07-28
Brief Title:
Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Community Based Group Psychoeducation for Relatives of Individuals With Mental Illness A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this one-arm pre-testpost-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 eg project leaders and teachers to participate in
In-depth interviews
Answering shorter questionnaires about provider acceptability
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 eg project leaders and teachers to participate in
In-depth interviews
Answering shorter questionnaires about provider acceptability
Detailed Description:
The programintervention
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 lifetheir 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 programs 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
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 lifetheir 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 programs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| S-20232000 - 66 | OTHER | None | None |
| 2325502 | OTHER | None | None |
| 2370733 | OTHER | Research Ethics Committee University of Southern Denmark | None |