NCT06131866

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 15, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2024

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1.4 years

First QC Date

November 3, 2023

Last Update Submit

March 21, 2024

Conditions

Bipolar DisorderCoping Skills

Keywords

Bipolar DisorderCopin SkillsMeaning and Purpose of LifeAcceptance and Commitment TherapyPsychoeducationRandomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Acceptance and commitment therapy-based psychoeducation and the level of finding meaning in life in patients with bipolar disorder

    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 Outcomes (1)

  • Acceptance and commitment therapy-based psychoeducation and coping skills in patients with bipolar disorder

    up to 12 weeks

Study Arms (8)

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

EXPERIMENTAL

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

Control group 1

NO INTERVENTION

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.

Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was applied

EXPERIMENTAL

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

Control group 2

NO INTERVENTION

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.

Intervention group 3 in which psychoeducation based on acceptance and commitment therapy was applied

EXPERIMENTAL

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

Control group 3

NO INTERVENTION

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.

Intervention group 4 in which psychoeducation based on acceptance and commitment therapy was applied

EXPERIMENTAL

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

Control group 4

NO INTERVENTION

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.

Interventions

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.

Intervention group 2 in which psychoeducation based on acceptance and commitment therapy was appliedIntervention group 3 in which psychoeducation based on acceptance and commitment therapy was appliedIntervention group 4 in which psychoeducation based on acceptance and commitment therapy was appliedintervention group 1 in which psychoeducation based on acceptance and commitment therapy was applied

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziantep University

Gaziantep, Şahinbey, 27010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A total of 8 groups, 4 intervention groups and 4 control groups
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomised controlled trial consisting of a total of 8 groups, 4 experimental and 4 control
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 14, 2023

Study Start

September 15, 2022

Primary Completion

February 25, 2024

Study Completion

March 20, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)