- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06131866
Acceptance and Commitment Therapy Based Psychoeducation, Meaning of Life and Coping Skills in Bipolar Disorder
March 21, 2024 updated by: Kubra TOHUMCU
The Effect of Acceptance and Commitment Therapy Based Psychoeducation on Meaning and Purpose of Life and Coping Skills in Patients With Bipolar Disorder
This research will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on coping skills and finding meaning in life in patients with bipolar disorder.
This research is planned as a randomised controlled experimental study.
The study will be conducted with euthymic stage patients diagnosed with bipolar disorder who applied to Adıyaman Besni State Hospital psychiatry outpatient clinic using randomisation method.
According to the power analysis result, the study will be applied to a total of 40 individuals, 20 experimental and 20 control.
"Individual Information Form" regarding socio-demographic characteristics, "Coping Attitudes Evaluation Scale COPE-R" and "Meaning and Purpose of Life Scale" will be used to collect the data.
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
Pre-tests will be applied to the patients in the intervention and control groups just before the training, post-test will be applied to the intervention group immediately after the training sessions are completed, and follow-up test will be applied one month after the post-test, i.e. in the 12th week.
After the pre-test was applied to the control group, the post-test will be applied in the 8th week and the follow-up test will be applied in the 12th week without any intervention.
In the evaluation of the data; descriptive statistical methods (frequency, mean), t-test, one way Anova and correlation analyses will be used.
Permission was obtained from the University Ethics Committee, the relevant institution and the individuals participating in the study.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bipolar disorder negatively affects individuals' mental and physical health, interpersonal relationships, educational and occupational functions.
Factors such as personality structure, coping with stress and social adaptation skills play an important role in the course of the disease as well as neurobiological factors.
Bipolar disorder is a difficult condition for people to cope with due to its chronic nature and these individuals have problems in interpersonal relationships and coping with stress.
Beyond what is perceived in relation to normal life, bipolar disorder causes individuals to experience large and complex extra dimensions in all aspects of their lives and to struggle for meaning in their lives.
Three indicators of an individual's psychological well-being are the individual's goals in life, awareness of his/her existing potential and the quality of interpersonal relationships.
In bipolar disorder, which also affects the psychological well-being of individuals, individuals often do not achieve complete remission despite pharmacotherapy.
In addition to pharmacotherapy, various psychosocial interventions such as cognitive behavioural therapies and psychoeducation have been developed and applied to treat bipolar disorder.
Acceptance and Commitment Therapy is one of the leading types of therapy methods called the third generation of cognitive behavioural therapies.
Instead of teaching individuals to control their feelings, thoughts, sensations, memories and other subjective situations, acceptance and stability therapy teaches individuals to recognise and accept these experiences and, most importantly, to embrace their negative experiences.
Acceptance and commitment therapy aims to change individuals' relationships with the emotions, thoughts, memories and physical sensations that they fear and avoid.
It uses acceptance and awareness strategies to teach individuals to focus on the present moment and to reduce avoidance and cognitive attachment.
Thus, individuals learn to clarify their goals and values and learn to adhere to behaviour change strategies.
Acceptance and commitment therapy is one of the psychotherapies supported by the American Psychological Association for most psychiatric conditions, including psychosis.
The transdiagnostic nature of acceptance and commitment therapy is compatible with mood disorders as well as psychotic symptoms.
Acceptance and commitment therapy has been shown to be effective in many psychopathological conditions, including bipolar disorder.
It is stated in the literature that an innovative group intervention combining acceptance and commitment therapy and psychoeducation approaches may be beneficial in individuals with bipolar disorder.
Psychoeducational programmes are auxiliary interventions that complement pharmacological treatment in order to further reduce the burden of the disease and relapses in mental disorders.
The effectiveness of psychoeducation in patients with bipolar disorder has been shown in many studies.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Şahinbey
-
Gaziantep, Şahinbey, Turkey, 27010
- Gaziantep University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- To be receiving outpatient treatment with the diagnosis of Bipolar Disorder according to DSM-5
- Being in euthymic mood according to the doctor's control at the time of the interview
- Having no problem in understanding and speaking Turkish
- Being literate
- Being in the 18-65 age group
- Not having undergone such training for the last 1 year
Exclusion Criteria:
- Presence of serious sensory and cognitive disabilities that would prevent answering the questionnaire
- Refusal to participate in the study after being informed
- Having another psychiatric diagnosis in addition to the diagnosis of bipolar disorder
- Having an attack period during the education process
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: intervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied
After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected.
In the 12th week, follow-up test will be applied and evaluation will be made.
|
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
|
|
No Intervention: Control group 1
After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied.
Then, the post-test will be applied 8 weeks later without any intervention.
One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned.
|
|
|
Experimental: Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was applied
After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected.
In the 12th week, follow-up test will be applied and evaluation will be made.
|
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
|
|
No Intervention: Control group 2
After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied.
Then, the post-test will be applied 8 weeks later without any intervention.
One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned.
|
|
|
Experimental: Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was applied
After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected.
In the 12th week, follow-up test will be applied and evaluation will be made.
|
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
|
|
No Intervention: Control group 3
After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied.
Then, the post-test will be applied 8 weeks later without any intervention.
One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned.
|
|
|
Experimental: Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was applied
After explaining the purpose of the study to the individuals, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' The pre-test will be applied by applying the "Meaning and Purpose of Life Scale", then the 8-week Acceptance and Commitment Therapy Based Psychoeducation programme will be applied and the post-test data will be collected.
In the 12th week, follow-up test will be applied and evaluation will be made.
|
Acceptance and Commitment Therapy Based Psychoeducation will be applied to the patients in the intervention group in the form of group education (consisting of 5-7 people), one session per week for eight weeks; no intervention will be applied to the control group.
|
|
No Intervention: Control group 4
After explaining the purpose of the study to the individuals participating in the study, after obtaining their consent, "Personal Information Form", "Coping Attitudes Evaluation Scale COPE-R" and '' Meaning and Purpose of Life Scale'' will be applied and pre-tests will be applied.
Then, the post-test will be applied 8 weeks later without any intervention.
One month after the post-test, i.e. at the 12th week, a follow-up test will be applied and an evaluation is planned.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance and commitment therapy-based psychoeducation and the level of finding meaning in life in patients with bipolar disorder
Time Frame: up to 12 weeks
|
The effect of acceptance and commitment therapy-based psychoeducation on individuals' levels of finding meaning in life in patients with bipolar disorder Personal Information Form and Meaning and Purpose of Life Scale pretests will be applied to the patients in the intervention group before the training.
Afterwards, acceptance and stability-based psychoeducation consisting of 8 modules will be applied.
Post-tests will be administered after the sessions and a follow-up test will be administered one month later (at the 12th week).
Meaning and Purpose of Life Scale minimum score=17, maximum score=85.
The high score obtained from the scale indicates that the level of meaning in the lives of individuals is high.
|
up to 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance and commitment therapy-based psychoeducation and coping skills in patients with bipolar disorder
Time Frame: up to 12 weeks
|
The effect of acceptance and commitment therapy-based psychoeducation on coping skills levels in patients with bipolar disorder Personal Information Form and Coping Attitudes Evaluation Scale COPE-R pretests will be applied to the patients in the intervention group before the training.
Afterwards, acceptance and stability-based psychoeducation consisting of 8 modules will be applied.
Post-tests will be administered after the sessions and a follow-up test will be administered one month later (at the 12th week).
Coping Attitudes Rating Scale COPE-R minimum score=32, maximum score=128.
The high score obtained from the scale indicates a high level of coping attitude.
|
up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2022
Primary Completion (Actual)
February 25, 2024
Study Completion (Actual)
March 20, 2024
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
November 11, 2023
First Posted (Actual)
November 14, 2023
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GAÜN KThmc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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