Behavioural Activation Therapy for Bipolar Disorder

NCT04317859 | Unknown

• 1 other identifier: BRAVE for Bipolar: 5924
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Bipolar Disorder

Keywords

Behavioural Activation; Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms

  The Beck Depression Inventory (BDI-II) is administered to measure the effectiveness of BA on depressive symptoms. Items in the BDI are scored on a scale of 0-63, where 63 is the maximum score and higher scores are associated with more severe symptoms.

  End of the study period (14 weeks)

• Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on manic symptoms

  The Altman Self-Rating Scale (ASRS) is administered to measure the effectiveness of BA on manic symptoms. The ASRS has 5 items and a maximum score of 20; higher scores are associated with increased severity.

  End of the study period (14 weeks)

Secondary Outcomes (2)

• Test the effects of BA on changes in health parameters

  End of the study period (14 weeks)

• Economic evaluation of the BA program in the study population.

  End of the study period (14 weeks)

Study Arms (2)

Behavioural Activation (Intervention)

EXPERIMENTAL

Originally a component of Cognitive Therapy, Behavioural Activation is the use of strategies such as activity scheduling, master/pleasure ratings, and graded task assignments to modify one's perception of specific situations. Behavioural Activation involves the use of activities to improve life situations and mood symptoms.

Behavioral: Behavioural Activation

Waitlist (Control)

NO INTERVENTION

The Control group (waitlist) will receive treatment as usual while waiting to receive BA intervention (at the end of intervention group therapy time, which will consist of 18 sessions over an 14 week period). This group will be assessed by clinical staff that offer treatment as usual for mood symptoms and quality of life measures during the waiting time.

Interventions

Behavioural Activation BEHAVIORAL

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).

Behavioural Activation (Intervention)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Bipolar Disorder
• Must be able to provide written informed consent
• Must be able to attend program sessions

You may not qualify if:

• Inability to understand written and spoken English
• Primary diagnosis other Bipolar Disorder.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L4E4S4, Canada

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Zainab Samaan, MBChB, PhD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Hudson

CONTACT

905.522.1155; jhudson@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 23, 2020
• Study Start: May 7, 2019
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)