MedTrace Logo

Behavioural Activation Therapy for Bipolar Disorder

NCT04317859 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-11-27

No results posted yet for this study

Summary

Mood disorders including bipolar disorder and depression are common disabling disorders with depression affecting 11.2 to 16.0% of the general population and the lifetime prevalence of bipolar disorders at an estimated 4.4%. Although treatment with antidepressants medications is common and effective in some patients, 42.7% of patients show inadequate response to treatment with antidepressants and a large proportion (55.3%) continue to have ongoing depressive symptoms. Psychological and behavioural interventions such as cognitive behavioural therapy (CBT) and behavioural activation (BA) are effective treatment for depression alone or in combination with antidepressants. Depression can also occur in the context of bipolar disorder which is characterized by recurrent episodes of depression and mania (DSM-5). The depressive episodes within bipolar disorder may be similar to depressive disorder, however the management of these episodes is fraught with the challenge that antidepressant pharmacotherapy may precipitate manic episodes and lead to further destabilization of bipolar disorder. Therefore, an alternative to antidepressants and additional therapies are needed to support patients' recovery and mood stability, as well as to achieve better treatment response and remission. BA is not currently available in a structured format and has not been tested for its effectiveness in bipolar disorders in a specialized hospital-based program. The evidence for BA has been investigated in depression however the evidence for bipolar disorder is lacking, therefore this study aims to assess the effectiveness of BA as treatment for bipolar disorder.

Conditions

Interventions

BEHAVIORAL

Behavioural Activation

Behavioural Activation (BA) is a therapy previously shown to be effective in depressive disorders. This form of therapy involves modification of activities in order to change perceptions of specific situations, thereby improving mood. The BA treatment program will consist of 18 two-hour visits over 14 weeks (twice weekly group visits for the first 8 weeks, followed by two individual visits over 6 weeks).

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    lead OTHER

Principal Investigators

  • Zainab Samaan, MBChB, PhD · St. Joseph's Healthcare Hamilton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-07
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317859 on ClinicalTrials.gov