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Care BurdenNCT06799325

The Effect of Acceptance and Commitment Therapy Intervention on Caregiver Burden in Caregivers of Schizophrenia Patients

A study testing acceptance and commitment therapy based stress management program in people with Care Burden and Schizophrenia, run by Cumhuriyet University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to learn the effects of Acceptance and Commitment Therapy based stress management program on psychological flexibility and caregiver burden in caregivers of schizophrenia patients. This study is a randomized controlled trial. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
acceptance and commitment therapy based stress management program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Mar 2024to Mar 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between the ages of 18-65,
  • A primary caregiver of a patient diagnosed with schizophrenia according to -
  • Diagnostic and statistical manual of mental disorders- V for more than 1 year,
  • A person who has lived in the same house with the patient for at least 6 months and is primarily responsible for the patient's care,
  • A person who has at least a secondary school degree,
  • A person who can communicate verbally

Who cannot join

  • Individuals with mental illness,
  • Individuals who do not live in the same house as the patient,
  • Individuals with perception and communication problems

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site, 1 recruiting
  • Sivas Cumhuriyet University Faculty of Health Sciences Nursing Department

    Sivas, Centre, 58900

    ZARİF G ARSLAN, +903464870000, gayeglc@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acceptance and Commitment Therapy-based Stress Management Program on Psychological Flexibility and Caregiver Burden in Caregivers of Schizophrenia Patients

The aim of this study was to learn the effects of Acceptance and Commitment Therapy based stress management program on psychological flexibility and caregiver burden in caregivers of schizophrenia patients. This study is a randomized controlled trial. The main questions it aims to answer are:

  • Does an acceptance and commitment therapy-based stress management program increase psychological flexibility in caregivers of patients with schizophrenia?
  • Does an acceptance and commitment therapy-based stress management program reduce caregiver burden in caregivers of schizophrenia patients?
  • What is the relationship between the level of psychological flexibility and care burden? Researchers will compare the intervention with a control group (no intervention) to see if an acceptance and commitment therapy-based stress management program increases psychological resilience and reduces caregiver burden in people with schizophrenia.
Read more

Participants will participate in the Acceptance and Commitment Therapy Based Stress Management Program, consisting of 6 sessions, one session per week, each session lasting 45 minutes.

The intervention group will visit the clinic at the end of the application (after 6 weeks), at 1 month, 2 months and 3 months to be administered the Psychological Flexibility Scale and the Caregiver Burden Scale.

They will do the homework given in the therapy program.

Read the detailed description

Approximately 25-50% of schizophrenia patients worldwide, and 70% of schizophrenia patients in Asia, live with their families. Schizophrenia-related symptoms affect the individual as well as their family and caregivers. The severity of disease symptoms and the decrease in productivity of patients increase the care burden of family members and affect their physical and psychological health. Caring for patients with schizophrenia is a difficult, sensitive, and time-consuming responsibility. Caregiving creates social, emotional, behavioral, and financial problems for caregivers and causes various limitations in their personal lives. Caregivers of patients with schizophrenia are at serious risk of caregiver burden and psychiatric morbidity.Caregivers of schizophrenia patients experience high levels of caregiver burden and stress. It has been reported that family interventions reduce the relapse rate and hospitalization time in schizophrenia, and increase the duration of remission. Therefore, implementation of interventions that reduce the caregiver burden is very important to provide the best care for the patient, while also preventing mental illnesses that may develop in family caregivers. Developing stress coping methods and psychological flexibility of caregivers of schizophrenia patients with an acceptance and commitment therapy-based stress management program may be effective in reducing the caregiver burden. It is thought that with the implementation of this program, caregivers will develop more effective coping behaviors against stress, and in parallel, the risk of caregiver burden, stress, and mental illness will decrease.

This research is a randomized controlled trial to determine the effects of an individual Acceptance and Commitment therapy-based stress management program on psychological flexibility and caregiver burden in caregivers of schizophrenia patients.

Research Hypothesis/Hypotheses H1. At the end of the application of the acceptance and commitment therapy based stress management program, there is a difference between the intervention and control group psychological flexibility scores.

H2. At the end of the application of the acceptance and commitment therapy based stress management program, there is a difference between the intervention and control group care burden scores.

H3. At the end of the application of the acceptance and commitment therapy based stress management program, there is a difference between the intervention and control group care burden scores in the first, second and third months.

H4. At the end of the application of the acceptance and commitment therapy based stress management program, there is a difference between the intervention and control group psychological flexibility scores in the first, second and third months.

The Universe and Sample of the Study The universe of this study will consist of the caregivers of patients diagnosed with schizophrenia who were hospitalized in Sivas Hospital and Sivas Cumhuriyet University Application and Research Hospital psychiatry clinic between March 22, 2024 and March 01, 2025. The number of patients to be included in the study sample was determined by performing power analysis with the G-Power 3.1.9.4 sample volume calculation program. Accordingly, when the standard deviation was one, the effect size was 0.76, the significance level was 0.05 and (1-β)=0.80, the power of the study was calculated as 0.80678. The sample size will consist of the caregivers of 60 patients. 30 of the caregivers will form the intervention group (n1) and 30 will form the control group (n2).

Measurement Tools Used in the Study

  1. Personal Information Form:
  2. Psychological Flexibility Scale:
  3. Caregiver Burden Scale:
  4. DISCERN (Quality Criteria for Consumer Health Information) Scale: It was to be used in the evaluation of the content and quality of educational materials. The DISCERN measurement tool, which consists of three sections, includes 16 questions that question the content of the material.

Obtaining Expert Opinions A total of 5 expert opinions were obtained regarding the acceptance and commitment therapy-based stress management guide, including 3 faculty members specialized in psychiatric nursing, 1 faculty member specialized in public health and 1 faculty member specialized in clinical psychology. The experts were asked to evaluate the prepared guide in accordance with the Written Materials Appropriateness Evaluation Form and the DISCERN Scale. The expert opinions evaluated with the DISCERN Scale were analyzed. The intervention program was finalized in line with the opinions. The preliminary application of the research was carried out and changes were made regarding the aspects that needed to be adjusted.

Research Process The research will be conducted in the psychiatry clinics of Sivas Hospital and Sivas Cumhuriyet University Hospital. Caregivers of schizophrenia patients receiving inpatient treatment will be interviewed in the interview room of the psychiatry clinic between the research dates. Consent forms will be obtained from those who want to participate in the study and the study will be conducted on caregivers who meet the participation criteria. Individuals who agree to participate in the study will be assigned to the intervention and control groups through randomization. The first interview will be conducted with the intervention and control groups and the Psychological Flexibility Scale, Caregiver Burden Scale and Personal Information Form will be filled out.

The intervention group will be informed about the program and its goals. The Acceptance and Commitment Therapy Based Stress Management Program consisting of 6 sessions, 1 session per week and each session lasting 45 minutes, will be applied to the intervention group.

The purpose of the research will be explained to the control group and it will be stated that the scales will be applied at certain intervals within the scope of this research and measurements will be made simultaneously with the intervention group.

No program will be applied to the control group during the application and follow-up periods.

At the end of the application (after 6 weeks), the psychological flexibility scale and the caregiver burden scale will be applied to the intervention and control groups in the 1st month, 2nd month and 3rd month.

Data Analysis The data obtained from our study will be loaded into the Statistical Package for the Social Sciences program (Ver: 22.0) and when the parametric test assumptions are met (Kolmogorov Smirnov), Variance Analysis, Bonferroni test, significance test of the difference between two means will be used in repeated measurements, and when the parametric test assumptions are not met, Friedman test, Wilcoxon test, Mann Whitney U test and Chi-square test will be used and the error level will be taken as 0.05.

Being tested
acceptance and commitment therapy based stress management program
Keywords
schizophrenia, care burden, acceptance and commitment therapy, stress management, psychological flexibility
Medical subject headings
Caregiver Burden, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acceptance and commitment therapy based stress management programBehavioural

    The Stress Management Program Based on Acceptance and Commitment Therapy will be applied to the intervention group, consisting of 6 sessions, 1 session per week, and each session lasting 45 minutes.

Study groups in NCT06799325
Study groupRoleWhat they receive
Intervention groupExperimentalThe Stress Management Program Based on Acceptance and Commitment Therapy will be applied to the intervention group, consisting of 6 sessions, 1 session per week, and each session lasting 45 minutes. After the program, scales will be applied in the 1st month, 2nd month and 3rd month.
Receives: Behavioral: acceptance and commitment therapy based stress management program
control groupNo interventiononly scales will be applied and no intervention will be made. Following the application of the first scale, scales will be applied at 1 month, 2 months and 3 months.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Caregiver Burden Scale

    The scale consists of a total of 22 statements to determine the level of impact on the lives of caregivers. The scale, which can be completed in a question-answer format by the caregiver at home or with the researcher, has a Likert-type assessment ranging from 0 to 4 as never, rarely, sometimes, often, or almost always. The minimum score from the scale is 0, while the maximum score is 88. The items in the scale are mostly social and emotional, and a high scale score indicates high distress. The reliability study of the scale, which has been used by different researchers in Turkey, was translated by İnci and colleagues in 2006. The Cronbach alpha value indicating the reliability coefficient was found to be 0.95 for the Caregiver Burden Scale, indicating a high level of reliability.

    Measured: 6 weeks after registration, In the 1st month, in the 2nd month, in the 3rd month

Secondary outcomes (1)
  1. Psychological Flexibility Scale

    Validity study and Turkish adaptation of the scale were conducted and Cronbach's Alpha internal consistency reliability coefficient was found to be .79. The scale consists of 28 items and 5 sub-dimensions. It is a 7-point Likert-type scale. Items 2, 3, 5, 6, 8, 18, 20, 22, 23, 24 and 25 are scored reversely. The lowest score that can be obtained from the scale is 28, and the highest score is 196. In the evaluation of the scale items, high scores obtained from each sub-scale indicate that individuals are psychologically flexible.

    Measured: 6 weeks after registration, In the 1st month, in the 2nd month, in the 3rd month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2025
  2. Study start25 Mar 2024
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
One intervention group and a control group The Acceptance and Commitment Therapy Based Stress Management Program consisting of 6 sessions, 1 session per week and each session lasting 45 minutes, will be applied to the intervention group. At the end of the application (after 6 weeks), the Psychological Flexibility Scale and the Caregiver Burden Scale will be applied to the intervention group. After 6 weeks, in the 1st month, 2nd month and 3rd month, the Psychological Flexibility Scale and the Caregiver Burden Scale will be applied to the intervention group.
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06799325
Sponsor's protocol ID
CU-SBF-ZGA-01
Status last verified
Mar 2024
First submitted
23 Jan 2025
Last updated
29 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing acceptance and commitment therapy based stress management program in people with Care Burden and Schizophrenia, run by Cumhuriyet University 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2025. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ZARİF G ARSLAN (+905419026156, zarifgayegulcu@cumhuriyet.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Caregiver Burden Scale (time frame: 6 weeks after registration, In the 1st month, in the 2nd month, in the 3rd month). 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 29 Jan 2025; AzTrials last refreshed its copy on 3 Nov 2026.

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