Behavioural Activation for Bipolar Depression

Official title

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

Overview

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.

Interventions

• Behavioral Behavioural Activation (BA)
  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 con

Primary outcome measures

• Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) [Time frame: through study completion, an average of 7 months]
• Therapy uptake rate [Time frame: through study completion, an average of 7 months]
• Therapy completion rate [Time frame: through study completion, an average of 7 months]
• Change in activity levels as measured by consumer connected health devices [Time frame: through study completion, an average of 7 months]
• Change in Sleep Duration measured by health device [Time frame: through study completion, an average of 7 months]
• No significant adverse reaction for participants [Time frame: through study completion, an average of 7 months]

Secondary outcome measures (11)

• Altman Self-Rating Mania Scale (ASRM) [Time frame: 1 week]
• Work and Social Adjustment Scale (WSAS) [Time frame: 24 hours]
• Hamilton Depression Scale (HAM-D) [Time frame: 1 week]
• Brief Quality of Life in Bipolar Disorder (Brief QoLBD) [Time frame: 1 week]
• General Anxiety Disorder Assessment - 7 (GAD7) [Time frame: 2 weeks]
• Behavioral Activation for Depression Scale (BADS) [Time frame: 1 week]
• Snaith-Hamilton Pleasure Scale (SHAPS) [Time frame: 1 week]
• Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) [Time frame: Six months]
• Young mania rating scale [Time frame: 48 hours]
• Six daily questions [Time frame: 24 hours]
• The Quality of Behavioral Activation Scale (Q-BAS) [Time frame: 1 week]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Iceland · 1 center

• Landspitali university hospital — Reykjavik

Identifiers

NCT: NCT06022913 · BD0323

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗