Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Dec 2022

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1 year study duration

Study Start

First participant enrolled

December 1, 2022

Completed

10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed

13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed

Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

September 21, 2023

Last Update Submit

December 29, 2023

Conditions

Bipolar Disorder

Keywords

Bipolar DisorderPsychological FlexibilityImpulsivityAcceptance and Commitment TherapyPsychoeducation

Outcome Measures

Primary Outcomes (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.
up to 12 weeks

Secondary Outcomes (1)

The effect of psychoeducation based on acceptance and commitment therapy on impulsivity level in bipolar disorder patients
up to 12 weeks

Study Arms (12)

intervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied

EXPERIMENTAL

Personal 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.