Behavioural Activation for Bipolar Depression

NCT06022913 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-04-16

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • Landspitali University Hospital

    collaborator OTHER
  • Reykjavik University

    lead OTHER

Principal Investigators

  • Brynja B Magnúsdóttir, PhD · Reykjavik University

  • Anna S Islind, PhD · Reykjavik University

  • Steinunn G Sigurðardóttir, MSc · Reykjavik University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Iceland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06022913 on ClinicalTrials.gov