search
Back to results

Effect of Dialectical Behavior in Patients With Bipolar Disorder

Primary Purpose

Dialectical Behavior Therapy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Dialectical behavior therapy
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dialectical Behavior Therapy

Eligibility Criteria

50 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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) -

Sites / Locations

  • Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialectical behavior therapy

Routine psychological care

Arm Description

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.

they will receive psychological care such as stress management and social skills training.

Outcomes

Primary Outcome Measures

Difficulties in Emotional Regulation Scale (DERS)
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).

Secondary Outcome Measures

Distress Tolerance Scale (DTS)
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).

Full Information

First Posted
February 14, 2023
Last Updated
February 14, 2023
Sponsor
Alexandria University
search

1. Study Identification

Unique Protocol Identification Number
NCT05741268
Brief Title
Effect of Dialectical Behavior in Patients With Bipolar Disorder
Official Title
Effect of Dialectical Behavior Therapy on Emotion Regulation Difficulties, Distress Tolerance, and Social Functioning Among Patients With Bipolar Disorder: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialectical Behavior Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dialectical behavior therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine psychological care
Arm Type
Active Comparator
Arm Description
they will receive psychological care such as stress management and social skills training.
Intervention Type
Behavioral
Intervention Name(s)
Dialectical behavior therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difficulties in Emotional Regulation Scale (DERS)
Description
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).
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Distress Tolerance Scale (DTS)
Description
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).
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Social Functioning Scale (SFS)
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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) -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman Taha
Organizational Affiliation
Egypt Faculty of Nursing Alexandria, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Nursing
City
Alexandria
ZIP/Postal Code
21523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33392824
Citation
Musket CW, Hansen NS, Welker KM, Gilbert KE, Gruber J. A pilot investigation of emotional regulation difficulties and mindfulness-based strategies in manic and remitted bipolar I disorder and major depressive disorder. Int J Bipolar Disord. 2021 Jan 4;9(1):2. doi: 10.1186/s40345-020-00206-0.
Results Reference
background
PubMed Identifier
35093412
Citation
Miola A, Cattarinussi G, Antiga G, Caiolo S, Solmi M, Sambataro F. Difficulties in emotion regulation in bipolar disorder: A systematic review and meta-analysis. J Affect Disord. 2022 Apr 1;302:352-360. doi: 10.1016/j.jad.2022.01.102. Epub 2022 Jan 29.
Results Reference
background
PubMed Identifier
31174453
Citation
Dodd AL, Gilbert K, Gruber J. Beliefs about the automaticity of positive mood regulation: examination of the BAMR-Positive Emotion Downregulation Scale in relation to emotion regulation strategies and mood symptoms. Cogn Emot. 2020 Mar;34(2):384-392. doi: 10.1080/02699931.2019.1626700. Epub 2019 Jun 7.
Results Reference
background
PubMed Identifier
28577590
Citation
Eisner L, Eddie D, Harley R, Jacobo M, Nierenberg AA, Deckersbach T. Dialectical Behavior Therapy Group Skills Training for Bipolar Disorder. Behav Ther. 2017 Jul;48(4):557-566. doi: 10.1016/j.beth.2016.12.006. Epub 2017 Jan 6.
Results Reference
background

Learn more about this trial

Effect of Dialectical Behavior in Patients With Bipolar Disorder

We'll reach out to this number within 24 hrs