Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial

Completed

• Conditions: Bipolar Disorder
• Interventions: Behavioral: Dialectical Behaviour Therapy

• Registration Number: NCT02637401
• Lead Sponsor: University of Exeter

Brief Summary

Bipolar Disorders (BD) typically involve repeated episodes of both depression and excessively high mood or irritability (hypomania or mania). BD presents considerable challenges for the individual, his or her supporters, and society more generally. Medication is generally considered to be the mainstay treatment, however a substantial number of individuals with BD continue to experience episodes despite use of medication. Furthermore, ongoing mood instability either outside of episodes, or as the main feature of their BD, is a significant difficulty experienced by many. Whilst studies suggest that certain psychological therapies can be helpful for people experiencing full bipolar episodes, or to reduce risk of future episodes, there are no evidencebased psychological therapies available for individuals experiencing ongoing mood instability. Dialectical Behaviour Therapy (DBT) was developed several decades ago as an approach for people with Borderline Personality Disorder. DBT aims to give individuals who experience rapid and intense shifts in affect skills for managing this. Despite the many similarities in the symptoms experienced by individuals with Borderline Personality Disorder and those with Bipolar Disorder only a small number of studies have tested DBT for BD, and no studies to date have specifically investigated DBT as a means to help individuals with ongoing mood instability. We have developed a version of groupbased DBT that draws upon our own research to adapt standard DBT for this client group (DBTBD).

The group is designed to be delivered efficiently within the U.K. healthcare system whilst meeting the needs of individual participants through use of additional individual sessions and a mobile phone application. The current study investigates how acceptable DBTBD is to clinicians and patients, and whether - for the small number of individuals in the study -changes in symptoms and key ways of thinking and behaving appear to take place across the period of treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2015-12-17
• Study First Posted: 2015-12-22
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Therapy group	Dialectical Behaviour Therapy	Dialectical behaviour therapy: a psychological therpay involving 16 group sessions plus approximately 5 individual meetings over 4 months.

Primary Outcome Measures

Name	Time	Method
Acceptability of the therapy (% completing treatment)	10 months
Acceptability of the therapy and study procedures	10 months	Qualitiative feedback from participants
Feasibility of the study procedures	10 months	recruitment rate; feedback from referrers and clincians / researchers

Secondary Outcome Measures

Name	Time	Method
Clinical effectiveness	15 months	symptoms, quality of life, recovery status. Analysis focuses upon the sensitvity of these measures to change, and pre-post correlations.
Process measures	10 months	self report measures of key psychological processes hypothesised to be changed by therapy. Analysis focuses upon the sensitvity of these measures to change, and pre-post correlations.

Trial Locations

Locations (1)

University of Exeter; 🇬🇧 Exeter, Devon, United Kingdom