Behavioural Activation for Bipolar Depression

NCT ID: NCT06022913

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-22
• Study Completion Date: 2025-12-31

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.

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 week wait

Participant waits for 2 weeks after their baseline assessment before commencing therapy.

Group Type: OTHER

Behavioural Activation (BA)

Intervention Type: BEHAVIORAL

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.

3 week wait

Participant waits for 3 weeks after their baseline assessment before commencing therapy.

Group Type: OTHER

Behavioural Activation (BA)

Intervention Type: BEHAVIORAL

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.

4 week wait

Participant waits for 4 weeks after their baseline assessment before commencing therapy.

Group Type: OTHER

Behavioural Activation (BA)

Intervention Type: BEHAVIORAL

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.

5 week wait

Participant waits for 5 weeks after their baseline assessment before commencing therapy.

Group Type: OTHER

Behavioural Activation (BA)

Intervention Type: BEHAVIORAL

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.

Interventions

Behavioural Activation (BA)

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Landspitali University Hospital

OTHER

Sponsor Role: collaborator

Reykjavik University

OTHER

Sponsor Role: lead

Responsible Party

Brynja Bjork Magnusdottir

Assistant professor, Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brynja B Magnúsdóttir, PhD

Role: STUDY_CHAIR

Reykjavik University

Anna S Islind, PhD

Role: PRINCIPAL_INVESTIGATOR

Reykjavik University

Steinunn G Sigurðardóttir, MSc

Role: PRINCIPAL_INVESTIGATOR

Reykjavik University

Locations

Landspitali university hospital

Reykjavik, , Iceland

Site Status: RECRUITING

Countries

Iceland

Central Contacts

Halla Ó Ólafsdóttir, Cand. psych

Role: CONTACT

hallaosh@landspitali.is

8688371

Brynja Bj Magnúsdóttir, PhD

Role: CONTACT

brynjabm@ru.is

8489685

Facility Contacts

Halla Ó Ólafsdóttir, Cand. psych

Role: primary

hallaosh@landspitali.is

003548688371

Brynja B Magnúsdóttir, PhD, cand psych

Role: backup

brynjabm@ru.is

003548489685

Other Identifiers

BD0323

Identifier Type: -

Identifier Source: org_study_id