Behavioural Activation Therapy for Bipolar Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: St. Joseph's Healthcare Hamilton
Disqualifiers: Non-english speakers, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
45678How 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.
456910Eligibility 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.
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioural Activation (Intervention)Experimental Treatment1 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 Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Joseph's Healthcare HamiltonHamilton, Canada
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Who Is Running the Clinical Trial?
St. Joseph's Healthcare HamiltonLead Sponsor
References
Implementing a structured psychosocial interventions group programme for people with bipolar disorder. [2018]It has been reported that, at any time, over half of the people with bipolar disorder are receiving no active treatment. Despite the availability of effective medications and psychotherapies, research concludes that the care of bipolar disorder in everyday practice is often deficient. Evidence base reports the effectiveness of psychosocial interventions using many of the same ideas as the recovery approach; both attempt to place clients at the heart of service delivery. This paper reports on the development and implementation of three pilot group programmes for service users with bipolar disorder, in a community clinical setting in South East England. The group programme design and development was based upon the evidence-based psychosocial interventions advocated in national clinical guidelines and research literature. The programme incorporated the key effective psychosocial interventions and self-management mechanisms within its 12 sessions spanning over 3 months, followed by three booster sessions in 6 months' time. Twenty-three service users have to date completed the programme. Participant feedback will be discussed and reported to inform further development and research implications of such innovative evidence-based interventions for service users with bipolar disorder.
Psychosocial Interventions for Bipolar Disorder: Perspective from the Behavioral Approach System (BAS) Dysregulation Theory. [2021]Research has emerged providing consistent support for the behavioral approach system (BAS) dysregulation theory of bipolar disorder. The objective of the current article is to examine the extent to which findings from the BAS dysregulation theory can inform psychosocial interventions for bipolar disorder. Towards this end, we first provide an overview of the BAS dysregulation theory. Second, we review extant research on psychosocial interventions for bipolar disorder. And, third, we discuss means by which research and theory in line with the BAS dysregulation model can inform psychosocial interventions for bipolar disorder. Particular attention is given to the clinical implications of research suggesting that bipolar disorder is characterized by high drive/incentive motivation, ambitious goal-setting, and perfectionism in the achievement domain.
[Effectiveness of Behavioral Activation for the Treatment of Severe Depression in Clinical Settings]. [2021]Objectives Among interventions that have been shown to be efficacious in the treatment of depression, behavioural activation (AC) is receiving increasing attention as the evidence supporting its effectiveness continues to accumulate. Although the efficacy of AC for the treatment of depression has been established through numerous randomized controlled trials, studies evaluating the effectiveness of AC when implemented in mental health settings are rare and there is insufficient supportive data. This step is, however, essential to the validity and the generalization of the treatment to the reality of clinical settings. This study focuses on AC applied to take into account the reality of clinical settings and patients seeking treatment. It evaluates the effectiveness of group-based AC for the treatment of severe depression in a clinical setting in a heterogeneous population in terms of diagnosis (unipolar and bipolar depression) and comorbidity (Axis I and II). Methods A sample of 45 participants with severe depression was recruited in a psychiatric hospital. Participants received a 10 sessions group intervention of AC. Questionnaires were administered to obtain pretreatment, post-treatment and four-week post-treatment data. The impact of the intervention was observed on measures of depression, behavioural activation, reinforcement, anxiety, social adjustment and quality of life. Various moderation effects associated with the heterogeneity of the sample were tested on the evolution of depressive symptoms. The integrity of the treatment administered by the therapists and the acceptability of the intervention by participants were also documented. Results Mixed model analyses of variance were performed to assess whether (a) AC caused a significant change at the end of treatment on depressive symptoms, behavioural activation, reinforcement, anxiety, social adjustment and quality of life and whether (b) gains were maintained after four weeks. A significant change was obtained between the pre-post measures on the average score of all these variables, with the exception of a subscale of the quality of life measure. Analyses were also performed to verify various moderating effects on the evolution of depressive symptoms, level of activation and reinforcement. No interaction effects are observed on depression, activation and reinforcement measures. There is no significant difference according to pretreatment severity category, diagnosis (unipolar vs bipolar), presence of comorbidity (other Axis I and/or Axis II disorder) or co-morbidity of Axis II disorder. As for the activation measure in people with bipolar depression versus unipolar depression, it should be noted that the result is at the threshold of statistical significance. Conclusion The results support the effectiveness of group-based AC for the treatment of severe depression in clinical settings in a heterogeneous population, as well as for the maintenance of gains after four weeks. The effectiveness of AC was also observed across all associated psychosocial measures.
Patient experiences with group behavioural activation in a partial hospital program. [2021]Behavioural activation (BA) is an evidence-based treatment for depression that has been primarily delivered in individual out-patient treatment. Prior research supports a positive participant experience in individual therapy; however, less is known about the patient experience in group therapy, which is common in acute psychiatric settings.
Adapted Behavioural Activation for Bipolar Depression: A Randomised Multiple Baseline Case Series. [2022]Behavioural Activation (BA) is associated with a substantial evidence base for treatment of acute unipolar depression, and has promise as an easily disseminable psychological intervention for bipolar depression. Using a randomised multiple baseline case series design we examined the feasibility and acceptability of an adapted version of BA in a U.K. outpatient sample of 12 adults with acute bipolar depression. Participants were allocated at random to a 3-8 week wait period before being offered up to 20 sessions of BA. They completed outcome measures at intake, pre- and post-treatment and weekly symptom measures across the study period. Retention in therapy was high (11/12 participants completed the target minimum number of sessions), and all participants returning acceptability measures reported high levels of satisfaction with the intervention. No therapy-related serious adverse events were reported, nor were there exacerbations in manic symptoms that were judged to be a result of the intervention. The pattern of change on outcome measures is consistent with the potential for clinical benefit; six of the nine participants with a stable baseline showed clinically significant improvement on the primary outcome measure. The findings suggest adapted BA for bipolar depression is a feasible and acceptable approach that merits further investigation.
Does Behavioural Activation Lack Credibility Among Those Who Need It Most? A Comparison of Responses to Rationales for Behavioural Activation and Schema Therapy. [2019]Behavioural activation (BA) is an effective front-line treatment for depression but some consumers find it unattractive or aversive, and its rationale unconvincing.
 "… 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]Brief Behavioural Activation (Brief BA) is a time limited psychological therapy for the treatment of depression symptoms in adolescents. Research on clients' experiences of the helpful and unhelpful aspects of psychological therapies is important for developing an understanding of the therapeutic process, and for helping to improve interventions and therapists' skills. The aim of this study was to explore 12-19 year old's experiences of the helpful and unhelpful aspects of Brief BA.
Behavioral Activation System (BAS) differences in bipolar I and II disorder. [2022]A growing body of evidence supports the Behavioral Activation System (BAS) dyresgulation model of bipolar disorder, however its application to bipolar II disorder is limited. The current study examines its potential relevance to bipolar I and II disorders. We specifically sought to determine whether bipolar sub-types would differ in terms of BAS sensitivity, and examined for differential prospective relationships between BAS sensitivity and bipolar I and II symptom expression.
Behavioural activation therapy for depression in adults. [2022]Behavioural activation is a brief psychotherapeutic approach that seeks to change the way a person interacts with their environment. Behavioural activation is increasingly receiving attention as a potentially cost-effective intervention for depression, which may require less resources and may be easier to deliver and implement than other types of psychotherapy.
Adjunctive Behavioral Activation for the Treatment of Bipolar Depression: A Proof of Concept Trial. [2018]Grounded in a model focused on exposure to response-contingent positive reinforcement, and with evidence supporting its acute treatment effects for unipolar depression, an adjunctive behavioral activation (BA) intervention may be especially well suited to the treatment of bipolar depression. The goal of this study was to modify BA for the adjunctive treatment of bipolar depression and to pilot it in a proof of concept trial to assess its preliminary feasibility and acceptability for this population.