- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07643714
Effects of ACT-Based Psychoeducation on Caregivers of Individuals With Mental Disorders
The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Psychological Resilience, Stress Management, and Caregiver Burden in Caregivers of Individuals With Mental Disorders
This randomized controlled trial aimed to examine the effects of Acceptance and Commitment Therapy (ACT)-based psychoeducation program on psychological resilience, stress management, and caregiver burden in caregivers of individuals with mental disorders. Participants were randomly assigned to either the intervention or control group. The intervention group received ACT-based psychoeducation while the control group received no intervention.
H1-1: The mean psychological resilience scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group.
H1-2: The mean stress management scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly higher compared to caregivers in the control group.
H1-3: The mean caregiver burden scores of caregivers in the intervention group who received the ACT-based psychoeducation program are significantly lower compared to caregivers in the control group.
H1-4: The effects of the ACT-based psychoeducation program on psychological resilience, stress management, and caregiver burden differ significantly between caregivers of individuals diagnosed with schizophrenia and caregivers of individuals diagnosed with bipolar disorder.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kahramanmaraş, Turkey (Türkiye)
- Kahramanmaras Necip Fazil City Hospital, Psychiatry Outpatient Clinic and Community Mental Health Center
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Aged 18 years or older Being a first-degree caregiver of an individual with severe mental disorder followed at a CMHC or outpatient clinic Turkish-speaking and at least primary school graduate No communication problems and open to cooperation Not having participated in any ACT-based or similar psychoeducation program in the last 6 months No alcohol/substance use disorder No psychiatric diagnosis Having regularly attended the intervention sessions -
Exclusion Criteria:Not meeting the inclusion criteria
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Schizophrenia - Intervention Group
Caregivers of individuals diagnosed with schizophrenia who participated in the ACT-based psychoeducation program
|
ACT-based psychoeducation program delivered to caregivers of individuals with mental disorders (schizophrenia and bipolar disorder).
The program was based on Acceptance and Commitment Therapy principles and consisted of 8 sessions.
It aimed to improve psychological resilience, stress management, and reduce caregiver burden.
Sessions were conducted in group format.
|
|
No Intervention: Schizophrenia - Control Group (No intervention)
Caregivers of individuals with schizophrenia who received no intervention.
|
|
|
Experimental: Bipolar Disorder - Intervention Group
Caregivers of individuals with bipolar disorder who received ACT-based psychoeducation.
|
ACT-based psychoeducation program delivered to caregivers of individuals with mental disorders (schizophrenia and bipolar disorder).
The program was based on Acceptance and Commitment Therapy principles and consisted of 8 sessions.
It aimed to improve psychological resilience, stress management, and reduce caregiver burden.
Sessions were conducted in group format.
|
|
No Intervention: Bipolar Disorder - Control Group
Caregivers of individuals with bipolar disorder who received no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Resilience
Time Frame: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Psychological Resilience Scale for Adults at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
|
Stress Management
Time Frame: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Stress Coping Styles Scale at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
|
Caregiver Burden
Time Frame: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Caregiver Burden Scale at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychological Flexibility
Time Frame: Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Measured with the Acceptance and Action Questionnaire-II (AAQ-II) at baseline, post-intervention, and at 2-month follow-up
|
Baseline, post-intervention (8 weeks), and 2-month follow-up
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-13.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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