Behavioural Activation for Bipolar Depression
- Conditions
- Bipolar Depression
- Interventions
- Behavioral: Behavioural Activation (BA)
- Registration Number
- NCT06022913
- Lead Sponsor
- Reykjavik University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 week wait Behavioural Activation (BA) Participant waits for 3 weeks after their baseline assessment before commencing therapy. 4 week wait Behavioural Activation (BA) Participant waits for 4 weeks after their baseline assessment before commencing therapy. 2 week wait Behavioural Activation (BA) Participant waits for 2 weeks after their baseline assessment before commencing therapy. 5 week wait Behavioural Activation (BA) Participant waits for 5 weeks after their baseline assessment before commencing therapy.
- Primary Outcome Measures
Name Time Method Therapy uptake rate through study completion, an average of 7 months Number of participants randomised who attend at least 1 treatment session
Therapy completion rate through study completion, an average of 7 months Proportion of participants that attend at least 8 treatment sessions
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) through study completion, an average of 7 months Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Change in activity levels as measured by consumer connected health devices through study completion, an average of 7 months Measures of activity levels as by Withings health devices
Change in Sleep Duration measured by health device through study completion, an average of 7 months Measures of sleep duration by Withings health devices
No significant adverse reaction for participants through study completion, an average of 7 months Participant reports of adverse events elicited by researchers and therapists
- Secondary Outcome Measures
Name Time Method Brief Quality of Life in Bipolar Disorder (Brief QoLBD) 1 week 12 item self-report measure of disorder-specific quality of life
Altman Self-Rating Mania Scale (ASRM) 1 week 5 item self-report measure of hypomania symptoms over the past week
Hamilton Depression Scale (HAM-D) 1 week 17 item observer-rated scale measuring symptoms of depression over the past week
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND) Six months 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
The Quality of Behavioral Activation Scale (Q-BAS) 1 week To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions
Work and Social Adjustment Scale (WSAS) 24 hours 5 item self-report scale of functional impairment attributable to an identified problem
Behavioral Activation for Depression Scale (BADS) 1 week 25 item self-report measure of changes in activation and avoidance over the past week
Snaith-Hamilton Pleasure Scale (SHAPS) 1 week 14 item self-report measure of level of anhedonia
Young mania rating scale 48 hours 11 item observer-rated scale measuring the severity of manic states
General Anxiety Disorder Assessment - 7 (GAD7) 2 weeks 7 item self-report measure of anxiety symptoms
Six daily questions 24 hours Six daily questions in mobile about goal achievement, mood, sleep etc
Trial Locations
- Locations (1)
Landspitali university hospital
🇮🇸Reykjavík, Iceland