Actively Recruiting
Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)
Led by Reykjavik University · Updated on 2025-04-16
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Reykjavik University
Lead Sponsor
L
Landspitali University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Bipolar disorder affects 1-3% of people worldwide and involves episodes of mania or hypomania along with periods of depression that can disrupt daily life. While psychological therapies exist for depression without mania, there is limited research on their effectiveness for bipolar depression. Behavioral activation therapy (BA), proven effective for unipolar depression, aims to help people restore healthier activity patterns and improve mood stability in bipolar disorder. This study evaluates the feasibility and pilot effectiveness of BA adapted for bipolar depression (BA-BD) among people seeking treatment at a specialized bipolar disorder service. Participants will receive up to 20 individual sessions of BA-BD therapy, each about 50 minutes, plus one booster session three months after therapy ends. The study uses a randomized wait period design where participants start therapy after waiting 2, 3, 4, or 5 weeks from baseline assessment. BA-BD is provided alongside usual treatment to see if it can be effectively integrated as an additional therapy for bipolar depression. During the study, participants complete regular questionnaires and interviews to assess changes in depression symptoms, activity levels, and sleep using health devices. Researchers will monitor therapy uptake, completion rates, and any adverse reactions over an average of 7 months. Various scales measuring mania, depression, anxiety, quality of life, and behavioral activation will be used to evaluate outcomes and safety throughout the study period.
CONDITIONS
Brief Title
Behavioural Activation for Bipolar Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of Bipolar I or II Disorder confirmed by DIAMOND assessment
- Clinical level of depression confirmed by PHQ-9 and DIAMOND diagnostic criteria
- Working knowledge of written and spoken Icelandic sufficient for therapy and assessments
- Willingness to participate in up to 20 individual therapy sessions and complete study assessments
You will not qualify if you...
- History of learning disability, organic brain changes, or substance dependence affecting therapy use
- Current significant risk of self-harm or suicide not manageable in outpatient clinic
- Lack of capacity to give informed consent
- Currently receiving other psychosocial therapy for depression or bipolar disorder
- Presence of another primary condition requiring different therapy focus (e.g., PTSD, psychosis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 to 5 weeks
Participants wait for a period of 2 to 5 weeks after their baseline assessment before starting therapy.
1 baseline visit before wait period
Duration - Variable duration depending on session scheduling
Participants receive up to 20 individual behavioural activation therapy sessions to help re-establish healthy activity patterns, with one booster session three months after therapy ends. Sessions last approximately 50 minutes each and include home practice between sessions.
Up to 20 therapy sessions plus 1 booster session
Duration - Up to 7 months from study start
Participants are followed up after therapy completion to assess ongoing outcomes and therapy effects up to an average of 7 months from study start.
Visits as scheduled for outcome assessments
Trial Site Locations
Total: 1 location
1
Landspitali university hospital
Reykjavik, Iceland, 101
Actively Recruiting
Research Team
H
Halla Ó Ólafsdóttir, Cand. psych
B
Brynja Bj Magnúsdóttir, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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