- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06655688
Acceptance and Commitment Therapy (ACT) for Family Members After a First Psychotic Attack
The Effect of Acceptance and Commitment Therapy on Self-Stigmatization, Coping With Stress and Psychological Resilience Levels of Family Members After First Psychotic Attack Diagnosis
Study Overview
Status
Intervention / Treatment
Detailed Description
This study is a pretest, posttest, follow-up, randomized controlled experimental study. This study will be conducted with family members of individuals diagnosed with FPA who come to the psychiatry outpatient clinic of a training and research hospital. According to the results of G-power analysis, the minimum sample size of the study was calculated as 32 (intervention 16, control 16). Personal Information Form will be applied to the individuals before randomization. The computer-aided https://www.random.org/integers/ program will be used to assign the intervention and control groups without bias. It is planned that the intervention group will consist of 8-12 participants and the program will be implemented as two intervention groups. The Acceptance and Commitment Therapy (ACT) Based Intervention Program will be implemented online in eight sessions. Each session will last 60-90 minutes on average. Two sessions will be held for one group per week. The control group will not receive any intervention from the researcher. The intervention groups will be followed up with a post-test after the program is completed and three months later, while the control group will be followed up with a post-test four weeks and three months later.
In the preparation of the interventions and planning of the sessions based on ACT, the researcher utilized studies in the literature and the basic ACT training she had received. The sessions were prepared based on six components of psychological flexibility found at the basis of ACT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34668
- Saglik Bilimleri Universitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Acceptance to participate in the research,
- Being responsible for the care of an individual who has been diagnosed with schizophrenia and other psychotic disorders according to DSM-5 diagnostic criteria at least six months ago and at most five years ago,
- Living with the patient for at least one year,
- First-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is suitable for online interviewing (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
- Being literate,
- Communication is not a problem.
Exclusion Criteria:
- Refusal to participate in the research,
- Responsible for the care of an individual diagnosed with schizophrenia and other psychotic disorders for less than six months or more than five years according to DSM-V diagnostic criteria,
- Living with the patient for less than one year,
- No first-degree relatives (mother, father, siblings, adult children and spouse),
- The home environment is not suitable for online counseling (having a computer/smartphone, internet at home, the patient can be alone in the room during the session, etc.),
- Illiteracy,
- Communication problems.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: ACT
''Acceptance and Commitment Therapy (ACT) Based Intervention Program was applied to the intervention group.
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Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in eight sessions online.
Each session will last an average of 60-90 minutes.
There will be two sessions for one group per week.
|
|
No Intervention: Control
Arm Description: Only data collection was carried out.
No attempt was made by the researcher during the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Stigma Inventory for Families (SSI-F)
Time Frame: 6 month
|
The scale was developed to assess the self-stigmatization of family members of individuals diagnosed with schizophrenia.
The scores that can be obtained from the scale, which includes 3 factors and 14 items in total, including internalized stereotypes and withdrawal from society, concealment of the disease and perceived worthlessness, vary between 14-70.
A high score indicates a high level of self-stigmatization of the family member.
|
6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stress Coping Scale
Time Frame: 6 month
|
The scale consists of 23 items and is a 5-point Likert type.
It includes 3 sub-dimensions: seeking social support, problem-focused coping and avoidance-focused coping.
Items 10, 17 and 20 of the scale are reverse-scored.
The total score and subscale scores obtained from the scale provide information about individuals' coping strategies with stress.
The scale gives scores ranging from 23 to 115 reflecting the general level of coping strategies used by individuals to cope with stress.
High scores obtained from the scale and its subscales indicate an increased tendency to use relevant coping mechanisms.
|
6 month
|
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Brief Resilience Scale
Time Frame: 6 month
|
The scale was developed to measure the psychological resilience of individuals.
This scale, which consists of 6 items in 5-point Likert type, is a self-report measurement tool.
It is scored between "not at all appropriate" (1) and "completely appropriate" (5).
Items 2, 4 and 6 of these 6 items are reverse coded.
High scores indicate a high level of psychological resilience and low scores indicate a low level of psychological resilience.
|
6 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Duygu Özer, Asst. Prof., Bartın Unıversity
Publications and helpful links
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
- BARU-SBF-DO-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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