Effect of Dialectical Behavior in Patients With Bipolar Disorder

February 14, 2023 updated by: Rasha salah elsayed eweida, Alexandria University

Effect of Dialectical Behavior Therapy on Emotion Regulation Difficulties, Distress Tolerance, and Social Functioning Among Patients With Bipolar Disorder: A Randomized Controlled Trial

This study aims to:

• Determine the effect of implementing Dialectical Behavior Therapy on emotion regulation difficulties, distress tolerance, and social functioning among patients with bipolar disorder.

RESEARCH HYPOTHESIS Patients with bipolar disorder who are exposed to Dialectical Behavior Therapy will exhibit lower emotion regulation difficulties, distress tolerance, and higher social functioning than those who are not exposed to such training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The researchers decided to work on a convenient sample of 30 adult patients with bipolar disorder. Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation.

Study Type

Interventional

Enrollment (Actual)

30

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

  • Egypt
      • Alexandria, Egypt, 21523
        • Faculty of Nursing

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

50 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:1. Diagnosed with bipolar disorder for at least one month according to DSM V with no co-morbidity.

2. Their age does not exceed 60 years old. 3. Able to read and write. 4. Able & willing to participate in the study. 5. Living in Alexandria Governorate, Egypt.

Exclusion Criteria: demonstrate severe psychopathological symptom ( i.e: patient in acute stage)

-

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: Dialectical behavior therapy
Dialectical behavior therapy will be applied through psychoeducation, discussion, rehearsal, and homework assignments. Four modules were administered in Mindfulness, Emotion Regulation, Emotion Regulation, and Emotion Regulation.
Behavioral: Dialectical behavior therapy
14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in the following sequence 1. Mindfulness , 2. Emotion Regulation , 3. Distress Tolerance and 4. Interpersonal effectiveness.
Active Comparator: Routine psychological care
they will receive psychological care such as stress management and social skills training.
Behavioral: Dialectical behavior therapy
14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in 14) Dialectical behavior therapy will be applied through psychoeducation, discussion, rehrasal and homework assignments. It contains four modules were administered in the following sequence 1. Mindfulness , 2. Emotion Regulation , 3. Distress Tolerance and 4. Interpersonal effectiveness.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difficulties in Emotional Regulation Scale (DERS)
Time Frame: 2 weeks
This tool (DERS) is a 36-items self-report scale developed by Gratz and Roemer (2004) to assess emotion regulation difficulties. The scale items are classified into six general subscales; non- acceptance of emotional responses (6 items); difficulty engaging in goal-directed behaviors (5 items); impulse control difficulties (6 items); lack of emotional awareness (6 items); limited access to emotional regulation strategies (8 items), and lack of emotional clarity (5 items).
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Tolerance Scale (DTS)
Time Frame: 2 weeks
The DTS (Simons & Gaher, 2005) is a 15-item selfreport questionnaire that assesses tolerance of distress, appraisal of distress, attention absorbed by negative emotions, and regulation efforts to alleviate distress. Items are rated on a 1 to 5 scale (1 = strongly agree; 5 = strongly disagree) with lower scores indicating poorer tolerance of distress. The DTS scale has demonstrated good test-retest reliability. In the current study the internal consistency of the DTS was excellent (Cronbach's α = .92).
2 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Functioning Scale (SFS)
Time Frame: 2 weeks
The SFS is a 79-items self-report scale developed by Birchwood et al. (1990) to assess areas of social functioning of individuals with schizophrenia. The items are classified into seven subscales; withdrawal/social engagement (5 items), interpersonal communication (4 items), independence-performance (13 items), independence-competence (13 items), recreation (15 items), prosocial activities (22 items), and employment/occupational (5 items), in addition to two unscored preliminary questions (The latter two questions were excluded as they were measured in tool I).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Study Chair: Eman Taha, Egypt Faculty of Nursing Alexandria, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 2, 2023

Primary Completion (Actual)

January 15, 2023

Study Completion (Actual)

February 10, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Estimate)

February 23, 2023

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15122022

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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