NCT05741268

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

March 2, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

August 23, 2024

Status Verified

July 1, 2023

Enrollment Period

5 months

First QC Date

February 14, 2023

Last Update Submit

August 22, 2024

Conditions

Dialectical Behavior Therapy

Outcome Measures

Primary Outcomes (1)

  • 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).

    2 weeks

Secondary Outcomes (1)

  • Distress Tolerance Scale (DTS)

    2 weeks

Other Outcomes (1)

  • Social Functioning Scale (SFS)

    2 weeks

Study Arms (2)

Dialectical behavior therapy

EXPERIMENTAL

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

Routine psychological care

ACTIVE COMPARATOR

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

Behavioral: Dialectical behavior therapy

Interventions

Dialectical behavior therapyBEHAVIORAL

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.

Dialectical behavior therapyRoutine psychological care

Eligibility Criteria

Age50 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, 21523, Egypt

Location

Related Publications (4)

  • 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.

    PMID: 33392824BACKGROUND

  • 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.

    PMID: 35093412BACKGROUND

  • 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.

    PMID: 31174453BACKGROUND

  • 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.

    PMID: 28577590BACKGROUND

MeSH Terms

Interventions

Dialectical Behavior Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Eman Taha

    Egypt Faculty of Nursing Alexandria, Egypt

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

March 2, 2023

Primary Completion

July 15, 2023

Study Completion

September 10, 2023

Last Updated

August 23, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)