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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Psychoeducation based on Acceptance and Commitment Therapy
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.
Other: Psychoeducation based on Acceptance and Commitment Therapy
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.
Other: Psychoeducation based on Acceptance and Commitment Therapy
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.
Other: Psychoeducation based on Acceptance and Commitment Therapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kubra TOHUMCU

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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