Caregiver BurdenNCT07643714
Effects of ACT-Based Psychoeducation on Caregivers of Individuals With Mental Disorders
A study testing ACT-Based Psychoeducation Program in people with Caregiver Burden and Mental Disorders, run by Zeynep Özkök at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Mental Disorders
- What is being tested?
- ACT-Based Psychoeducation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2025to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Necip Fazil City Hospital, Psychiatry Outpatient Clinic and Community Mental Health Center
Kahramanmaraş
About this study
Official title: 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.
Read more
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.
- Conditions
- Caregiver Burden, Mental Disorders
- Being tested
- ACT-Based Psychoeducation Program
- Keywords
- Acceptance and Commitment Therapy, Psychoeducation, Caregiver, Psychological Resilience, Stress Management, Mental Disorders, Schizophrenia, Bipolar Disorder
- Medical subject headings
- Caregiver Burden, Mental Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-Based Psychoeducation ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia - Intervention Group | Experimental | Caregivers of individuals diagnosed with schizophrenia who participated in the ACT-based psychoeducation program Receives: Behavioral: ACT-Based Psychoeducation Program |
| Schizophrenia - Control Group (No intervention) | No intervention | Caregivers of individuals with schizophrenia who received no intervention. |
| Bipolar Disorder - Intervention Group | Experimental | Caregivers of individuals with bipolar disorder who received ACT-based psychoeducation. Receives: Behavioral: ACT-Based Psychoeducation Program |
| Bipolar Disorder - Control Group | No intervention | Caregivers of individuals with bipolar disorder who received no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Resilience
Measured with the Psychological Resilience Scale for Adults at baseline, post-intervention, and at 2-month follow-up
Measured: Baseline, post-intervention (8 weeks), and 2-month follow-up
Stress Management
Measured with the Stress Coping Styles Scale at baseline, post-intervention, and at 2-month follow-up
Measured: Baseline, post-intervention (8 weeks), and 2-month follow-up
Caregiver Burden
Measured with the Caregiver Burden Scale at baseline, post-intervention, and at 2-month follow-up
Measured: Baseline, post-intervention (8 weeks), and 2-month follow-up
Secondary outcomes (1)
Psychological Flexibility
Measured with the Acceptance and Action Questionnaire-II (AAQ-II) at baseline, post-intervention, and at 2-month follow-up
Measured: Baseline, post-intervention (8 weeks), and 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start6 Oct 2025
- Primary completion24 Nov 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Özkök
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zeynep Özkök, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643714
- Sponsor's protocol ID
- 2025-13.01
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared as this is a doctoral dissertation study conducted at a single institution.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acceptance and Commitment Therapy-Based Psychoeducation on Psychological Resilience, Stress Management, and Caregiver Burden in Caregivers of Individuals With Mental Disorders
- ClinicalTrials.gov ID
- NCT07643714
- Acronym / sponsor ID
- 2025-13.01
- Conditions
- Caregiver Burden, Mental Disorders
- Keywords
- Acceptance and Commitment Therapy, Psychoeducation, Caregiver, Psychological Resilience, Stress Management, Mental Disorders, Schizophrenia, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Zeynep ÖzkökUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia - Intervention Group | Experimental | Behavioral: ACT-Based Psychoeducation ProgramCaregivers of individuals diagnosed with schizophrenia who participated in the ACT-based psychoeducation program |
| Schizophrenia - Control Group (No intervention) | No intervention | –Caregivers of individuals with schizophrenia who received no intervention. |
| Bipolar Disorder - Intervention Group | Experimental | Behavioral: ACT-Based Psychoeducation ProgramCaregivers of individuals with bipolar disorder who received ACT-based psychoeducation. |
| Bipolar Disorder - Control Group | No intervention | –Caregivers of individuals with bipolar disorder who received no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT-Based Psychoeducation ProgramACT-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. | Behavioural | Bipolar Disorder - Intervention Group, Schizophrenia - Intervention Group |
Primary outcome
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
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
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
1 secondary outcome
Psychological Flexibility
Time frame: Baseline, post-intervention (8 weeks), and 2-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared as this is a doctoral dissertation study conducted at a single institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-Based Psychoeducation Program in people with Caregiver Burden and Mental Disorders, run by Zeynep Özkök at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Resilience (time frame: Baseline, post-intervention (8 weeks), and 2-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.