Behavioural Activation Therapy for Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

Behavioural Activation Therapy for Bipolar Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04317859
• Other study ID #: BRAVE for Bipolar: 5924
• Status: Recruiting
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: June 1, 2025

Study information

• Verified date: November 2023
• Source: St. Joseph's Healthcare Hamilton
• Contact: Jacqueline Hudson
• Phone: 905.522.1155
• Email: jhudson[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is a pragmatic randomized controlled trial to test the effectiveness of behavioural activation in bipolar disorder. The pragmatic randomized controlled trial study design is a parallel 1:1 allocation comparing behavioural activation plus treatment as usual to waitlist control group plus treatment as usual. For this study the investigators will adopt the following principals simulating naturalistic real life clinical setting to test the study question based on the pragmatic design:

No restrictive inclusion criteria will be used. Adults with bipolar disorder will be asked to participate in this study Clinicians will deliver the BA program to participants randomized to receive the intervention The intervention will be an add-on to treatment as usual The comparison group will receive treatment as usual that may include medications, CBT and other therapies as required and decided by their clinical care The primary outcome is clinically relevant (improvement in depressive and manic symptoms)

Both the intervention and control groups will be assessed as intention to treat analysis with no measures to improve adherence to the study intervention or the comparator.

Patients with a diagnosis of bipolar disorders attending the mood disorders clinic, referred for assessment of bipolar disorder at the clinic or referred from community or other hospital services to the mood disorders clinic will be approached for participation in the study. In addition, family practices in the community will be informed of the study and asked to refer directly to the trial. Following initial screening for eligibility, potential participants will be asked to provide written informed consent prior to any study related procedures.

The investigators will employ a parallel group design to evaluate the effects of behavioural activation intervention to improve bipolar disorder-related outcomes. Eligible and consenting patients will be randomly allocated to the intervention or control arms using a 1:1 allocation ratio. Allocations will be generated using the computerized system. The randomization will use a block randomization system of block sizes of 2, 4 and 6. Allocation will be conducted by a research personnel who is not a clinician and will not know the participant clinical status to maintain allocation concealment.

This trial is an open label trial as blinding is not possible for participants (behavioural activation intervention) or the clinician administering the intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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).

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Test the effects of BA on changes in health parameters	Quality of Life, as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), Short-Form 12 Health Survey (SF-12), and the Work and Social Adjustment Scale (WSAS). The Q-LES-Q-SF is a 14-item questionnaire scored between 0% and 100%, where higher percentages are indicative of a higher QOL. WSAS scores items between 0 (indicating no impairment) and 8 (indicating severe impairment); total scores greater than 20 indicate severe psychopathology and symptomology. The SF-12 generates two summary scores, the physical component score (PCS) and the mental component score (MCS); scores range between 0 and 100, where 100 is associated with the highest level of health state.	End of the study period (14 weeks)
Secondary	Economic evaluation of the BA program in the study population.	Economic evaluation of the BA program will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L), a commonly used measure of health status and quality of life in a variety of clinical conditions. Each of 5 items are scored between 0 to 4; the maximum score of the EQ-5D-5L is 1, with higher scores being associated with poorer health.	End of the study period (14 weeks)