This trial is active, not recruiting.

Condition bipolar disorder
Treatment dialectical behaviour therapy
Sponsor University of Exeter
Start date March 2015
End date January 2016
Trial size 13 participants
Trial identifier NCT02637401, 1415/002


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Dialectical behaviour therapy: a psychological therpay involving 16 group sessions plus approximately 5 individual meetings over 4 months.
dialectical behaviour therapy

Primary Outcomes

Acceptability of the therapy (% completing treatment)
time frame: 10 months
Acceptability of the therapy and study procedures
time frame: 10 months
Feasibility of the study procedures
time frame: 10 months

Secondary Outcomes

Clinical effectiveness
time frame: 15 months
Process measures
time frame: 10 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion criteria for patient participants are: i) aged 18 or over; i) meets DSMV criteria for Bipolar Spectrum Disorder; iii) current bipolar mood instability (over the past two years numerous periods with hypomanic symptoms that do not meet criteria for a hypomanic episode and numerous periods with depressive symptoms that do not meet criteria for a depressive episode, continuing into the past month); iv) client wishes to engage in psychological therapy that focusses primarily on ongoing mood instability and its consequences. Exclusion criteria are: i) current substance dependence disorder; ii) currently receiving other psychological therapy; iii) the patient is currently actively suicidal; iv) presenting difficulties that are characteristic of Borderline Personality Disorder rather than Bipolar Disorder and that would be an early treatment target in standard DBT (frequent and serious deliberate selfharm, marked disturbance in ability to form or maintain interpersonal relationships); v) presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example panic disorder with agoraphobia, Post Traumatic Stress Disorder); vi) the information available suggests that the person may present a significant risk to other group members (such as aggression, likelihood of carrying out sexual or other exploitation); vii) the person lacks capacity to consent to treatment or research participation; viii) currently experiencing an episode of mania.

Additional Information

Official title Group Dialectical Behavioural Therapy for Mood Instability Within Bipolar Disorder: An Open Trial
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Exeter.