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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Landspitali university hospital
Reykjavik, Iceland
RECRUITINGMinimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Time frame: through study completion, an average of 7 months
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Time frame: through study completion, an average of 7 months
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Time frame: 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
Time frame: through study completion, an average of 7 months
Change in Sleep Duration measured by health device
Measures of sleep duration by Withings health devices
Time frame: through study completion, an average of 7 months
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists
Time frame: through study completion, an average of 7 months
Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Time frame: 1 week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Time frame: 24 hours
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Time frame: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
Time frame: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Time frame: 2 weeks
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Time frame: 1 week
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Time frame: 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
Time frame: Six months
Young mania rating scale
11 item observer-rated scale measuring the severity of manic states
Time frame: 48 hours
Six daily questions
Six daily questions in mobile about goal achievement, mood, sleep etc
Time frame: 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
Time frame: 1 week
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