Behavioural Activation Therapy for Bipolar Disorder

Overseen By Jacqueline Hudson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: Non-english speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: 14 weeks

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Behavioural Activation Therapy for Bipolar Disorder?

Research shows that Behavioural Activation (BA) is effective for treating depression and has potential for bipolar depression. A study found that an adapted version of BA for bipolar depression was feasible and well-received, with participants showing significant improvement in symptoms. ^{1 2 3 4 5}

Is Behavioural Activation Therapy safe for humans?

Research on Behavioural Activation Therapy for bipolar depression shows it is generally safe, with no serious side effects reported and high satisfaction among participants. ^{4 5 6 7 8}

How is Behavioural Activation Therapy different from other treatments for bipolar disorder?

Behavioural Activation Therapy is unique because it focuses on changing how people interact with their environment to improve mood, and it is adapted from a successful treatment for unipolar depression. It is considered potentially easier to deliver and more cost-effective than other therapies, and it has shown promise in being both feasible and acceptable for people with bipolar depression. ^{4 5 6 9 10}

What is the purpose of this trial?

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.

Research Team

Zainab Samaan, MBChB, PhD

Principal Investigator

St. Joseph's Healthcare Hamilton

Eligibility Criteria

This trial is for individuals who can give written consent, attend program sessions, and have a clinical diagnosis of Bipolar Disorder. It's not suitable for those whose primary diagnosis isn't Bipolar Disorder or who can't understand English.

Inclusion Criteria

I have been diagnosed with Bipolar Disorder.

Must be able to provide written informed consent

I can attend all required program sessions.

Exclusion Criteria

Inability to understand written and spoken English

My primary diagnosis is not Bipolar Disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Behavioural Activation therapy in addition to usual care, consisting of 18 sessions over a 14-week period

14 weeks

18 sessions (in-person)

Follow-up

Participants are monitored for changes in health parameters and quality of life after the treatment phase

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Behavioural Activation

Trial Overview The trial tests Behavioural Activation (BA) therapy as an alternative to antidepressants for treating bipolar disorder. BA hasn't been structured or tested in hospital programs specifically for bipolar disorder before.

Participant Groups

Group I: Behavioural Activation (Intervention) Experimental Treatment 1 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.

Group II: Waitlist (Control) Active Control 1 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.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Findings from Research

A pilot program was developed for individuals with bipolar disorder, consisting of 12 sessions over 3 months, followed by 3 booster sessions, based on evidence-based psychosocial interventions.

So far, 23 participants have completed the program, highlighting the need for effective treatment options as many individuals with bipolar disorder are not receiving active care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing a structured psychosocial interventions group programme for people with bipolar disorder. Stern, T., Sin, J.[2018]

The behavioral approach system (BAS) dysregulation theory provides a framework for understanding bipolar disorder, highlighting issues like high motivation and perfectionism that can inform treatment strategies.

Research on psychosocial interventions for bipolar disorder can be enhanced by incorporating insights from the BAS dysregulation model, potentially leading to more effective therapeutic approaches tailored to the unique motivational characteristics of individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions for Bipolar Disorder: Perspective from the Behavioral Approach System (BAS) Dysregulation Theory. Nusslock, R., Abramson, LY., Harmon-Jones, E., et al.[2021]

Group-based behavioral activation (AC) was found to be effective in treating severe depression in a clinical setting, with significant improvements in depression symptoms, behavioral activation, anxiety, social adjustment, and quality of life among 45 participants after 10 sessions.

The benefits of AC were maintained four weeks post-treatment, demonstrating its potential for long-term effectiveness across a diverse population with varying diagnoses and comorbidities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of Behavioral Activation for the Treatment of Severe Depression in Clinical Settings]. Blanchet, V., Provencher, MD.[2021]

The study found that patients generally had a positive experience with Brief Behavioral Activation Treatment for Depression (BATD) delivered in a group setting, highlighting helpful aspects like motivation, goal setting, and activity scheduling.

Patients provided mixed feedback on certain elements, such as the focus on depression and the balance between lecture and participation, indicating areas for improvement in the group therapy format.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient experiences with group behavioural activation in a partial hospital program. Stein, AT., Tian, L., Cuthbert, K., et al.[2021]

A study involving 12 adults with acute bipolar depression found that an adapted version of Behavioral Activation (BA) was feasible and well-accepted, with high retention rates (11 out of 12 participants completed the therapy).

No serious adverse events or worsening of manic symptoms were reported, and six out of nine participants with stable baselines showed clinically significant improvement, indicating potential benefits of BA for treating bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. Wright, K., Mostazir, M., Bailey, E., et al.[2022]

Higher levels of childhood adversity were associated with lower credibility ratings for behavioral activation (BA) treatment, indicating that personal history can influence how individuals perceive treatment options.

Providing research evidence of BA's efficacy significantly increased its credibility ratings, making them comparable to schema therapy (ST), but individuals with a history of childhood adversity still preferred ST, suggesting a need for tailored approaches in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Behavioural Activation Lack Credibility Among Those Who Need It Most? A Comparison of Responses to Rationales for Behavioural Activation and Schema Therapy. Curley, S., Smout, MF., Denson, LA.[2019]

Adolescents aged 12-19 found Brief Behavioural Activation (BA) helpful for self-discovery, gaining coping tools, and having supportive conversations with their therapist, highlighting its effectiveness in treating depression symptoms.

However, challenges such as the therapy's duration and difficulties in maintaining progress after treatment were noted as unhelpful aspects, suggesting areas for improvement in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

 "… if I care about stuff, then other people care about me". Adolescents' experiences of helpful and unhelpful aspects of brief behavioural activation therapy for depression. Lewis-Smith, I., Pass, L., Jones, DJW., et al.[2021]

In a study of 151 participants with bipolar disorder, those with bipolar I showed significantly higher scores in BAS-Drive and Reward Responsiveness compared to those with bipolar II, indicating differences in behavioral activation sensitivity between the two subtypes.

Both bipolar I and II disorders exhibited a positive association between BAS sensitivity and mood variability, but BAS scores did not predict mood episode status over a 6-month follow-up, suggesting that while BAS sensitivity is relevant, it may not be a reliable indicator for future mood episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral Activation System (BAS) differences in bipolar I and II disorder. Fletcher, K., Parker, G., Manicavasagar, V.[2022]

Behavioural activation may be more effective than treatment as usual, humanistic therapy, and medication for depression, based on a systematic review of 53 studies involving 5495 participants, although the evidence quality varies.

The efficacy of behavioural activation appears comparable to cognitive behavioral therapy (CBT) and other psychological therapies, suggesting it is a viable treatment option, but confidence in these findings is limited due to concerns about the certainty of the evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioural activation therapy for depression in adults. Uphoff, E., Ekers, D., Robertson, L., et al.[2022]

A modified behavioral activation (BA) intervention was found to be feasible and acceptable for treating bipolar depression, with 10 out of 12 participants completing the 20-week trial and reporting high satisfaction levels.

Participants showed significant improvements in depressive symptoms, manic symptoms, and suicidal ideation after the treatment, suggesting that this approach may be a promising adjunctive therapy for bipolar depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive Behavioral Activation for the Treatment of Bipolar Depression: A Proof of Concept Trial. Weinstock, LM., Melvin, C., Munroe, MK., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Implementing a structured psychosocial interventions group programme for people with bipolar disorder. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions for Bipolar Disorder: Perspective from the Behavioral Approach System (BAS) Dysregulation Theory. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

[Effectiveness of Behavioral Activation for the Treatment of Severe Depression in Clinical Settings]. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Patient experiences with group behavioural activation in a partial hospital program. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Does Behavioural Activation Lack Credibility Among Those Who Need It Most? A Comparison of Responses to Rationales for Behavioural Activation and Schema Therapy. [2019]

7. England pubmed.ncbi.nlm.nih.gov

 "… if I care about stuff, then other people care about me". Adolescents' experiences of helpful and unhelpful aspects of brief behavioural activation therapy for depression. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Behavioral Activation System (BAS) differences in bipolar I and II disorder. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Behavioural activation therapy for depression in adults. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Adjunctive Behavioral Activation for the Treatment of Bipolar Depression: A Proof of Concept Trial. [2018]