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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Behavioral Activation Therapy can help people with bipolar disorder. Bipolar disorder involves mood swings, including depressive episodes that are difficult to manage with antidepressants alone. The trial compares this therapy to usual treatment to determine if it better stabilizes mood without causing manic episodes. Participants must have a clinical diagnosis of bipolar disorder and be able to attend the therapy sessions. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve future treatment options for bipolar disorder.

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 prior data suggests that Behavioural Activation Therapy is safe for treating bipolar disorder?

Research has shown that Behavioural Activation (BA) therapy is generally safe for individuals with mood disorders. BA therapy involves altering daily activities to enhance mood and has shown promise as a treatment for bipolar depression. Studies suggest that most patients tolerate BA therapy well, with no major safety concerns reported.

Participants have attended up to 20 therapy sessions without significant issues, making BA therapy an attractive option for those seeking alternatives to medication. Since it doesn't involve drugs, it may help avoid some side effects associated with antidepressants, especially in bipolar disorder, where medications can sometimes cause manic episodes.

In summary, BA therapy appears safe and may help improve mood without the risks linked to some medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Behavioural Activation Therapy for bipolar disorder because it offers a fresh approach to managing mood symptoms. Unlike traditional treatments like medication or cognitive therapy, Behavioural Activation focuses on using activities to directly improve life situations and mood. This therapy involves strategies like scheduling enjoyable activities and setting achievable goals, which can help modify how individuals perceive their daily experiences. By actively engaging patients in life-enhancing tasks, there is potential for significant improvement in mood and overall quality of life, making it a promising option for those seeking alternatives to medication.

What evidence suggests that Behavioural Activation Therapy might be an effective treatment for bipolar disorder?

Research has shown that Behavioral Activation (BA) therapy, which participants in this trial may receive, can help treat bipolar depression. Studies have found that BA improves mood by encouraging engagement in enjoyable activities and fostering a more positive outlook on situations. Early findings suggest that BA can complement other treatments for bipolar depression. Specifically, one case series demonstrated that patients felt better after attending structured BA sessions. While BA is well-researched for general depression, its benefits for those with bipolar disorder are still under investigation, but early results are promising. ^{1 2 3 4 6}

Who Is on the Research Team?

Zainab Samaan, MBChB, PhD

Principal Investigator

St. Joseph's Healthcare Hamilton

Are You a Good Fit for This Trial?

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

Must be able to provide written informed consent

I have been diagnosed with Bipolar Disorder.

I can attend all required program sessions.

Exclusion Criteria

Inability to understand written and spoken English

My primary diagnosis is not Bipolar Disorder.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9599144/

Adapted Behavioural Activation for Bipolar Depression Quantitative feasibility, acceptability and safety data and aggregate scores on clinical process and outcome measures are presented ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04317859

Behavioural Activation Therapy for Bipolar Disorder This form of therapy involves modification of activities in order to change perceptions of specific situations, thereby improving mood.

3. bpspsychub.onlinelibrary.wiley.com bpspsychub.onlinelibrary.wiley.com/doi/10.1111/bjc.12515

Patient experiences of behavioural therapy for bipolar ... It aims to improve mood by decreasing avoidance of feared punishing consequences and supporting re-engagement with meaningful and rewarding ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4855692/

Adjunctive Behavioral Activation for the Treatment of ... These study data suggest that a modified BA intervention may offer promise as an adjunctive approach for the acute treatment of bipolar depression.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03658824

Behavioural Activation for Bipolar Depression: A Case Series The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0140673616311400

Cost and Outcome of Behavioural Activation versus ... A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness ...