Effect of Dialectical Behavior in Patients With Bipolar Disorder

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT05741268
Collaborator
(none)
30
1
2
1.3
23.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Dialectical behavior therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Jan 2, 2023
Actual Primary Completion Date :
Jan 15, 2023
Actual Study Completion Date :
Feb 10, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Difficulties in Emotional Regulation Scale (DERS) [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).

Secondary Outcome Measures

  1. Distress Tolerance Scale (DTS) [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).

Other Outcome Measures

  1. Social Functioning Scale (SFS) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

  1. 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)

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Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Nursing Alexandria Egypt 21523

Sponsors and Collaborators

  • Alexandria University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Rasha salah elsayed eweida, assistant professor, Alexandria University
ClinicalTrials.gov Identifier:
NCT05741268
Other Study ID Numbers:
  • 15122022
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023