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

NCT06799325 | Recruiting

• 1 other identifier: CU-SBF-ZGA-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Care Burden; Schizophrenia; Caregiver Mental Health

Keywords

schizophrenia; care burden; acceptance and commitment therapy; stress management; psychological flexibility

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Psychological Flexibility Scale

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

Study Arms (2)

Intervention group

EXPERIMENTAL

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. After the program, scales will be applied in the 1st month, 2nd month and 3rd month.

Behavioral: acceptance and commitment therapy based stress management program

control group

NO INTERVENTION

only 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.

Interventions

acceptance and commitment therapy based stress management program BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University Faculty of Health Sciences Nursing Department

Sivas, Centre, 58900, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Schizophrenia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• havva tel, Professor

  havatel@cumhuriyet.edu.tr

  STUDY DIRECTOR

Central Study Contacts

ZARİF G ARSLAN

CONTACT

+905419026156; zarifgayegulcu@cumhuriyet.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: March 25, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)