Clinical trial NCT05741268: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dialectical Behavior Therapy
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

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Primary outcomes:
measure: Difficulties in Emotional Regulation Scale (DERS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Distress Tolerance Scale (DTS)
timeFrame: 2 weeks
Other outcomes:
measure: Social Functioning Scale (SFS)
timeFrame: 2 weeks
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Egypt Faculty of Nursing Alexandria, Egypt
name: Eman Taha
role: STUDY_CHAIR
References:
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.
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.
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.
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.