Behavioural Activation for Bipolar Depression

Study Overview
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Brief Summary
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Bipolar disorder (BD) affects between 1-3% of the world's population. People with BD experience episodes of mania or hypomania and in most cases, they experience periods of depression which can cause difficulties in daily life. Psychological therapies for people experiencing depression without mania or hypomania are widely available, but there is little research into how effective these therapies are for people with BD. Behavioral activation therapy (BA) is based on behavioral theory and has been proven to be an effective treatment for unipolar depression. It helps people re-establish healthier activity patterns and sleep regulation, especially in BD for mood stabilization. BA is theoretically and clinically well matched to the treatment of bipolar depression, but there is still very little research into offering BA to people with BD. The first aim of the current research is to implement BA for people with depression in Bipolar Disorder and study if it is feasible for this patient group. The second aim is to do a pilot study on the effectiveness of the treatment for this patient group. The research will be implemented with people seeking treatment at the specialized service for bipolar disorder at Landspítali University Hospital in Iceland. The participants will receive treatment as usual and the BA will be adjunctive. At least ten people, that are currently experiencing Bipolar Depression and are willing to take part, will receive up to 20 individual therapy sessions of BA that have been adapted for Bipolar Depression (BA-BD), and will complete regular questionnaires and interviews. The study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.

Official Title
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Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)

Conditions
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Bipolar Depression

Intervention / Treatment
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* Behavioral: Behavioural Activation (BA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: scoring in the clinical range on a self-report measure of depression severity (the PHQ-9) meeting diagnostic criteria for depression based on a diagnosis on Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) meeting diagnostic criteria for Bipolar I or II Disorder DIAMOND) participants will require a working knowledge of written and spoken Icelandic, sufficient to make use of therapy and complete research assessments without the need for a translator. Exclusion Criteria: current/past learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy current marked risk to self (i.e., self-harm or suicide) that we deem could not be appropriately managed in the Bipolar outpatient clinic at Landspitali. currently lacking the capacity to give informed consent currently receiving other psychosocial therapy for depression or bipolar disorder presence of another area of difficulty that the therapist and client believe should be the primary focus of intervention (for example, Post-Traumatic Stress Disorder, psychosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a case series using a multiple baseline design whereby participants are randomly allocated to one of 6 durations of wait at baseline before commencing treatment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 2 week wait<br>Participant waits for 2 weeks after their baseline assessment before commencing therapy. | Behavioral: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 3 week wait<br>Participant waits for 3 weeks after their baseline assessment before commencing therapy. | Behavioral: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 4 week wait<br>Participant waits for 4 weeks after their baseline assessment before commencing therapy. | Behavioral: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|
| Other: 5 week wait<br>Participant waits for 5 weeks after their baseline assessment before commencing therapy. | Behavioral: Behavioural Activation (BA)<br>* BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term. The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) | Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9) | through study completion, an average of 7 months | 
| Therapy uptake rate | Number of participants randomised who attend at least 1 treatment session | through study completion, an average of 7 months | 
| Therapy completion rate | Proportion of participants that attend at least 8 treatment sessions | through study completion, an average of 7 months | 
| Change in activity levels as measured by consumer connected health devices | Measures of activity levels as by Withings health devices | through study completion, an average of 7 months | 
| Change in Sleep Duration measured by health device | Measures of sleep duration by Withings health devices | through study completion, an average of 7 months | 
| No significant adverse reaction for participants | Participant reports of adverse events elicited by researchers and therapists | through study completion, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Altman Self-Rating Mania Scale (ASRM) | 5 item self-report measure of hypomania symptoms over the past week | 1 week | 
| Work and Social Adjustment Scale (WSAS) | 5 item self-report scale of functional impairment attributable to an identified problem | 24 hours | 
| Hamilton Depression Scale (HAM-D) | 17 item observer-rated scale measuring symptoms of depression over the past week | 1 week | 
| Brief Quality of Life in Bipolar Disorder (Brief QoLBD) | 12 item self-report measure of disorder-specific quality of life | 1 week | 
| General Anxiety Disorder Assessment - 7 (GAD7) | 7 item self-report measure of anxiety symptoms | 2 weeks | 
| Behavioral Activation for Depression Scale (BADS) | 25 item self-report measure of changes in activation and avoidance over the past week | 1 week | 
| Snaith-Hamilton Pleasure Scale (SHAPS) | 14 item self-report measure of level of anhedonia | 1 week | 
| Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) | Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence | Six months | 
| Young mania rating scale | 11 item observer-rated scale measuring the severity of manic states | 48 hours | 
| Six daily questions | Six daily questions in mobile about goal achievement, mood, sleep etc | 24 hours | 
| The Quality of Behavioral Activation Scale (Q-BAS) | To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bipolar depression, Bipolar Disorder, Behavioural Activation, Depression