AzTrials
AzTrials

Bipolar DisorderNCT06113887

The Effect of Acceptance and Commitment of Bipolar Disorder Patients

A study testing psychoeducation based on acceptance and commitment therapy in people with Bipolar Disorder, run by University of Gaziantep at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on psychological flexibility and impulsivity levels in patients with bipolar disorder. This study was planned as a randomised controlled experimental study. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bipolar Disorder
What is being tested?
psychoeducation based on acceptance and commitment therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2022to 15 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gaziantep University

    Gaziantep, Şahinbey, 27010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acceptance and Commitment Therapy Based Psychoeducation on Psychological Flexibility and Impulsivity Levels in Bipolar Disorder Patients

This study will be conducted to determine the effect of acceptance and commitment therapy-based psychoeducation on psychological flexibility and impulsivity levels in patients with bipolar disorder. This study was planned as a randomised controlled experimental study. The study will be conducted with 60 patients (Intervention: 30, Control: 30) in the euthymic stage diagnosed with bipolar disorder who applied to Adıyaman Besni State Hospital psychiatry outpatient clinic using randomisation method. "Introductory Information Form" about socio-demographic characteristics, "Psychological Flexibility Scale" and "Barratt Impulsivity Scale -11 Short Form" will be used for data collection. 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. Repeated Measures Analysis of Variance was used to compare the scale scores and Fisher Least Significant Difference test was used for multiple comparisons of Group*Time interaction. Permission was obtained from the University Ethics Committee, the relevant institution and the individuals participating in the study.

Read the detailed description

INTRODUCTION Bipolar disorder ranks sixth among the causes of disability in the world due to its serious individual, family, social and economic burden. In patients with bipolar disorder, functioning may be impaired even in the euthymic period and psychopathological dimensions such as impulsivity negatively affect functioning. Impulsivity is defined as taking action quickly without thinking beforehand or making a conscious decision, in other words, exhibiting behaviour without sufficient thought. Impulsivity has a central role in the etiopathogenesis of mood disorders. One of the reasons for the low functionality and quality of life of individuals diagnosed with bipolar disorder is that these individuals have lower psychological flexibility than healthy individuals. The concept of psychological flexibility is the ability of an individual to consciously connect with the present moment and to act in line with his/her values. Psychological flexibility is the cornerstone of healthy personal and social functioning. However, many forms of psychopathology lack these resilience processes. Interventions to increase resilience help both sick and healthy individuals and are believed to be an important force in increasing their effectiveness and satisfaction in life. Individuals with bipolar disorder are often disorganised in their daily lives, even when euthymic, and may also benefit from psychosocial treatments aimed at improving cognitive functioning to increase their ability to function in daily life.

Cognitive Behavioural Therapy is one of the important psychosocial interventions applied in bipolar disorder. The therapy model called Acceptance and Commitment Therapy is one of the leading therapy types among the third generation cognitive behavioural therapy approaches. The main aim of Acceptance and Commitment Therapy is to increase the general psychological flexibility of individuals. Psychological flexibility plays an important role in the etiology, course and clinical presentation of bipolar disorder, as in many psychiatric disorders. Treatment of impulsivity in patients with bipolar disorder is provided by pharmacotherapy and various psychotherapeutic approaches. People with high levels of psychological rigidity exhibit impulsive behaviours such as avoidance, escape or self-harm by turning to the use of psychoactive substances to reduce the intensity of their internal experiences that they define as negative or to get rid of them. Studies have shown the significant potential impact of Acceptance and Commitment Therapy in many mental health conditions, including mood disorders and psychotic symptoms. It is thought that the application of a psychoeducation programme based on acceptance and commitment therapy to individuals diagnosed with bipolar disorder may help to increase the psychological flexibility of these individuals and decrease impulsivity as a result of increased psychological flexibility. All developments related to the understanding of the etiology and treatment of impulsivity will make a significant contribution to the understanding of mental illnesses. As far as we can reach, there is no randomised controlled study in the literature in which the results of acceptance and commitment therapy-based psychoeducation interventions in individuals diagnosed with bipolar disorder have been published.

METHOD This research is a randomised controlled experimental study. The research is planned to be conducted in Adıyaman Besni State Hospital between November 2022 and November 2023. The population of the study will consist of individuals who applied to the Psychiatry Outpatient Clinic of Adıyaman Besni State Hospital on the dates of the study, who received outpatient treatment with the diagnosis of bipolar according to Diagnostic and Statistical Manual of Mental Disorders-5 and who were in the euthymic period according to the doctor's control. Using the randomisation method, 60 individuals diagnosed with bipolar disorder who meet the inclusion criteria, volunteer to participate in the study and apply on the data collection dates of the study will constitute the sample of the study. The research will be completed with a total of 60 patients (30 experimental, 30 control) by taking 30 individuals diagnosed with bipolar disorder into the experimental group and 30 individuals into the control group.

G Power programme was used to calculate the sample size. The data will be collected by the researcher Kübra Tohumcu by face-to-face interview technique in the training room of Adıyaman Besni State Hospital. The patients constituting the sample of the study will be directed to the researcher by the outpatient clinic doctor. The patients who will be directed to the researcher by the doctor will first be informed about the research and the patients who meet the inclusion criteria will be determined as experimental and control groups by randomisation method.

It is planned to apply Acceptance and Commitment Therapy Based Psychoeducation Programme to the patients to be included in the experimental group. Personal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form pre-tests will be applied to the patients in the experimental and control groups just before the training. In the first interview with the patients in the experimental group, information about the training will be given and training days and hours will be determined. Then, acceptance and stability-based psychoeducation consisting of 8 modules will be applied to the individuals in the experimental group once a week as a single module. Each session of acceptance and stability therapy-based psychoeducation, which will last for 8 weeks in total, will be 45-60 minutes. Sessions will consist of 5-7 people on average and will be held as group training. The groups will be closed groups and new patients will not be included in the groups after the training sessions begin. In order to complete the sufficient number of data, new groups will be formed with the patients recruited later. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form will be applied to the experimental group. One month after the post-test, i.e. in the 12th week, a follow-up test will be applied to the experimental group. The control group will be administered the post-test at the 8th week and the follow-up test at the 12th week without any intervention after the pre-test.

Data Collection Tools Personal Information Form: This form, organised by the researchers, includes 17 questions to determine the demographic information of the participants.

Psychological Flexibility Scale: The scale is a 7-point Likert-type scale (1=strongly disagree, 7=strongly agree) consisting of 28 items. The scale has 5 sub-dimensions: "Values and behaviour in line with values", "Being in the moment", "Acceptance", "Contextual Self" and "Dissociation". When evaluating the scale, 6 different sub-scores can be obtained, including the scores obtained from each sub-dimension and the total score. The lowest score to be obtained from the scale is 28 and the highest score is 196. High scores obtained from the scale indicate the high psychological flexibility of individuals.

Barratt Impulsivity Scale -11 Short Form: The scale consists of a total of 15 items and three subscales. These subscales are lack of planning, motor impulsivity and attention impulsivity. The items in the scale are evaluated using a 4-point Likert-type scale (1=rarely/never, 4=almost always/always).

Data Analysis: The data obtained from the study will be analysed in Statistical Package for Social Sciences 22 package programme. Repeated Measures Analysis of Variance was used to compare the scale scores and Fisher Least Significant Difference test was used for multiple comparisons of Group*Time interaction.

Being tested
psychoeducation based on acceptance and commitment therapy
Keywords
Bipolar Disorder, Psychological Flexibility, Impulsivity, Acceptance and Commitment Therapy, Psychoeducation
Medical subject headings
Bipolar Disorder, Impulsive Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychoeducation based on acceptance and commitment therapyOther

    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.

Study groups in NCT06113887
Study groupRoleWhat they receive
intervention group 1 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 1No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.
Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 2No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.
Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 3No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.
Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 4No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.
Intervention group 5 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 5No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.
Intervention group 6 in which psychoeducation based on acceptance and commitment therapy was appliedExperimentalPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test, acceptance and stability-based psychoeducation consisting of 8 modules will be implemented once a week as a single module. Each session of the acceptance and stability therapy-based psychoeducation, which will last 8 weeks in total, will be implemented for 45-60 minutes. Immediately after the training sessions are completed, the post-test; Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) will be administered. A follow-up test will be administered one month after the post-test, i.e. in the 12th week.
Receives: Other: psychoeducation based on acceptance and commitment therapy
Control group 6No interventionPersonal Information Form, Psychological Flexibility Scale and Barratt Impulsivity Scale -11 Short Form (BIS-11-SF) pre-tests will be applied. After the pre-test is administered, post-test will be administered in the 8th week and follow-up tests will be administered in the 12th week without any intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The effect of psychoeducation based on acceptance and commitment therapy on psychological flexibility level in bipolar disorder patients

    The effect of psychoeducation based on acceptance and commitment therapy on psychological flexibility level in bipolar disorder patients.

    Personal Information Form, Psychological Flexibility Scale pre-tests 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). Psychological Flexibility Scale minimum score=28, maximum score=196. High scores indicate high psychological flexibility of individuals. The results will be evaluated in line with the data obtained.

    Measured: up to 12 weeks

Secondary outcomes (1)
  1. The effect of psychoeducation based on acceptance and commitment therapy on impulsivity level in bipolar disorder patients

    The effect of psychoeducation based on acceptance and commitment therapy on impulsivity levels in bipolar disorder patients.

    Personal Information Form, Barratt Impulsivity Scale-11 Short Form pre-tests 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). The Barratt Impulsivity Scale, the first and original name of the scale, has a minimum score=15 and a maximum score=60. High scores indicate high impulsivity level of individuals. The results will be evaluated in line with the data obtained.

    Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start1 Dec 2022
  3. Primary completion15 Nov 2023
  4. Study completion15 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 10 groups, 5 intervention groups and 5 control groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06113887
Sponsor's protocol ID
Gaziantep University KTOHUMCU
Status last verified
Dec 2023
First submitted
21 Sep 2023
Last updated
2 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing psychoeducation based on acceptance and commitment therapy in people with Bipolar Disorder, run by University of Gaziantep at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The effect of psychoeducation based on acceptance and commitment therapy on psychological flexibility level in bipolar disorder patients (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in