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临床试验/NCT06799325
NCT06799325招募中不适用

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

Cumhuriyet University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Caregiver Burden Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

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.

干预措施: acceptance and commitment therapy based stress management program (Behavioral)

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.

结局指标

主要结局

Caregiver Burden Scale

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

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.

次要结局

  • Psychological Flexibility Scale(6 weeks after registration, In the 1st month, in the 2nd month, in the 3rd month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

ZARİF GAYE ARSLAN

research assistant

Cumhuriyet University

研究点 (1)

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