NCT02637401

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

December 17, 2015

Last Update Submit

May 16, 2018

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (3)

  • Acceptability of the therapy (% completing treatment)

    10 months

  • Acceptability of the therapy and study procedures

    Qualitiative feedback from participants

    10 months

  • Feasibility of the study procedures

    recruitment rate; feedback from referrers and clincians / researchers

    10 months

Secondary Outcomes (2)

  • Clinical effectiveness

    15 months

  • Process measures

    10 months

Study Arms (1)

Therapy group

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

Behavioral: Dialectical Behaviour Therapy

Interventions

Dialectical Behaviour TherapyBEHAVIORAL
Therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with frequent bipolar mood swings.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX4 4QG, United Kingdom

Location

Related Publications (1)

  • Wright K, Palmer G, Javaid M, Mostazir M, Lynch T. Psychological therapy for mood instability within bipolar spectrum disorder: a single-arm feasibility study of a dialectical behaviour therapy-informed approach. Pilot Feasibility Stud. 2020 Apr 15;6:46. doi: 10.1186/s40814-020-00586-1. eCollection 2020.

    PMID: 32318271DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Dialectical Behavior Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2015

First Posted

December 22, 2015

Study Start

March 1, 2015

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

May 21, 2018

Record last verified: 2018-05

Locations

GB(1)