NCT06022913 Behavioural Activation for Bipolar Depression
| NCT ID | NCT06022913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reykjavik University |
| Condition | Bipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-11-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-11-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Brynja B Magnúsdóttir, PhD
STUDY CHAIR
Reykjavik University
Frequently Asked Questions
Who can join the NCT06022913 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06022913 currently recruiting?
Yes, NCT06022913 is actively recruiting participants. Contact the research team at hallaosh@landspitali.is for enrollment information.
Where is the NCT06022913 trial being conducted?
This trial is being conducted at Reykjavik, Iceland.
Who is sponsoring the NCT06022913 clinical trial?
NCT06022913 is sponsored by Reykjavik University. The principal investigator is Brynja B Magnúsdóttir, PhD at Reykjavik University. The trial plans to enroll 10 participants.
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