Recruiting

Behavioural Activation

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT04317859

Conditions

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Behavioural Activation

Study Details

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

Study ID

NCT04317859

Start date

May 7, 2019

Status verified date

Nov, 2023

Completion date

Jun 1, 2025

Anticipated

Primary completion date

Jun 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Behavioural Activation (Intervention)

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.

no intervention: Waitlist (Control)

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

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).

Primary outcome measure

  • Assess the effectiveness of a structured, therapist administered, group therapy program of Behavioural Activation (BA) in addition to usual care, on depressive symptoms [ Time Frame: 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 [ Time Frame: End of the study period (14 weeks) ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L4E4S4

Contacts

Principal Investigator:

Zainab Samaan, MBChB, PhD

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Nov 27, 2023

Last verified

Nov, 2023

Keywords

  • Behavioural Activation
  • Bipolar Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2023-11-27.