Behavioural Activation for Bipolar Depression

NCT06022913 | Recruiting

• 1 other identifier: BD0323
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Bipolar depression; Bipolar Disorder; Behavioural Activation; Depression

Outcome Measures

Primary Outcomes (6)

• Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)

  Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)

  through study completion, an average of 7 months

• Therapy uptake rate

  Number of participants randomised who attend at least 1 treatment session

  through study completion, an average of 7 months

• Therapy completion rate

  Proportion of participants that attend at least 8 treatment sessions

  through study completion, an average of 7 months

• Change in activity levels as measured by consumer connected health devices

  Measures of activity levels as by Withings health devices

  through study completion, an average of 7 months

• Change in Sleep Duration measured by health device

  Measures of sleep duration by Withings health devices

  through study completion, an average of 7 months

• No significant adverse reaction for participants

  Participant reports of adverse events elicited by researchers and therapists

  through study completion, an average of 7 months

Secondary Outcomes (11)

• Altman Self-Rating Mania Scale (ASRM)

  1 week

• Work and Social Adjustment Scale (WSAS)

  24 hours

• Hamilton Depression Scale (HAM-D)

  1 week

• Brief Quality of Life in Bipolar Disorder (Brief QoLBD)

  1 week

• General Anxiety Disorder Assessment - 7 (GAD7)

  2 weeks

Study Arms (4)

2 week wait

OTHER

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

Behavioral: Behavioural Activation (BA)

3 week wait

OTHER

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

Behavioral: Behavioural Activation (BA)

4 week wait

OTHER

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

Behavioral: Behavioural Activation (BA)

5 week wait

OTHER

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

Behavioral: Behavioural Activation (BA)

Interventions

Behavioural Activation (BA) 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.

2 week wait; 3 week wait; 4 week wait; 5 week wait

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Reykjavik University: lead
• Landspitali University Hospital: collaborator

Study Sites (1)

Landspitali university hospital

Reykjavik, 101, Iceland

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder; Depression

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Brynja B Magnúsdóttir, PhD

  Reykjavik University

  STUDY CHAIR

• Anna S Islind, PhD

  Reykjavik University

  PRINCIPAL INVESTIGATOR

• Steinunn G Sigurðardóttir, MSc

  Reykjavik University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Halla Ó Ólafsdóttir, Cand. psych

CONTACT

8688371; hallaosh@landspitali.is

Brynja Bj Magnúsdóttir, PhD

CONTACT

8489685; brynjabm@ru.is

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 5, 2023
• Study Start: November 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Access will be possible from the date of publication.
• Access Criteria: The dataset will be anonymous and registered with a metadata-only record, allowing the research team to control access to the dataset, and restricting it to appropriately qualified third parties.

Locations

IC (1)