Clinical trial NCT06022913: Behavioural Activation for Bipolar Depression
Official title: Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Depression
Keywords: Bipolar depression
Bipolar Disorder
Behavioural Activation
Depression
Lead sponsor: Reykjavik University
Sponsor class: OTHER
Collaborators: name: Landspitali University Hospital
First posted: 2023-09-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
timeFrame: through study completion, an average of 7 months
measure: Therapy uptake rate
timeFrame: through study completion, an average of 7 months
measure: Therapy completion rate
timeFrame: through study completion, an average of 7 months
measure: Change in activity levels as measured by consumer connected health devices
timeFrame: through study completion, an average of 7 months
measure: Change in Sleep Duration measured by health device
timeFrame: through study completion, an average of 7 months
measure: No significant adverse reaction for participants
timeFrame: through study completion, an average of 7 months
Secondary outcomes:
measure: Altman Self-Rating Mania Scale (ASRM)
timeFrame: 1 week
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 24 hours
measure: Hamilton Depression Scale (HAM-D)
timeFrame: 1 week
measure: Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
timeFrame: 1 week
measure: General Anxiety Disorder Assessment - 7 (GAD7)
timeFrame: 2 weeks
measure: Behavioral Activation for Depression Scale (BADS)
timeFrame: 1 week
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: 1 week
measure: Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
timeFrame: Six months
measure: Young mania rating scale
timeFrame: 48 hours
measure: Six daily questions
timeFrame: 24 hours
measure: The Quality of Behavioral Activation Scale (Q-BAS)
timeFrame: 1 week
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: Landspitali university hospital
Study officials:
affiliation: Reykjavik University
name: Brynja B Magnúsdóttir, PhD
role: STUDY_CHAIR
affiliation: Reykjavik University
name: Anna S Islind, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Reykjavik University
name: Steinunn G Sigurðardóttir, MSc
role: PRINCIPAL_INVESTIGATOR
References: