Behavioural Activation for Bipolar Depression

Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Depression
• Intervention / Treatment: Behavioral: Behavioural Activation (BA)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Halla Ó Ólafsdóttir, Cand. psych; Phone Number: 8688371; Email: hallaosh@landspitali.is
• Study Contact Backup: Name: Brynja Bj Magnúsdóttir, PhD; Phone Number: 8489685; Email: brynjabm@ru.is

Study Locations

• Iceland
  • Reykjavík, Iceland, 101
    • Recruiting
    • Landspitali University Hospital
    • Contact: Halla Ó Ólafsdóttir, Cand. psych; Phone Number: 003548688371; Email: hallaosh@landspitali.is
    • Contact: Brynja B Magnúsdóttir, PhD, cand psych; Phone Number: 003548489685; Email: brynjabm@ru.is

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 2 week wait; Participant waits for 2 weeks after their baseline assessment before commencing therapy.	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.
Other: 3 week wait; Participant waits for 3 weeks after their baseline assessment before commencing therapy.	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.
Other: 4 week wait; Participant waits for 4 weeks after their baseline assessment before commencing therapy.	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.
Other: 5 week wait; Participant waits for 5 weeks after their baseline assessment before commencing therapy.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Altman Self-Rating Mania Scale (ASRM)	5 item self-report measure of hypomania symptoms over the past week	1 week
Work and Social Adjustment Scale (WSAS)	5 item self-report scale of functional impairment attributable to an identified problem	24 hours
Hamilton Depression Scale (HAM-D)	17 item observer-rated scale measuring symptoms of depression over the past week	1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)	12 item self-report measure of disorder-specific quality of life	1 week
General Anxiety Disorder Assessment - 7 (GAD7)	7 item self-report measure of anxiety symptoms	2 weeks
Behavioral Activation for Depression Scale (BADS)	25 item self-report measure of changes in activation and avoidance over the past week	1 week
Snaith-Hamilton Pleasure Scale (SHAPS)	14 item self-report measure of level of anhedonia	1 week
Young mania rating scale	11 item observer-rated scale measuring the severity of manic states	48 hours
Six daily questions	Six daily questions in mobile about goal achievement, mood, sleep etc	24 hours
The Quality of Behavioral Activation Scale (Q-BAS)	To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions	1 week
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)	Standardized interview to establish whether the participant meets research diagnostic criteria for lifetime Bipolar I or II Disorder, current depressive episode, and to establish whether they are experiencing current substance dependence	Six months

Collaborators and Investigators

• Sponsor: Reykjavik University
• Collaborators: Landspitali University Hospital
• Investigators: Study Chair: Brynja B Magnúsdóttir, PhD, Reykjavik University; Principal Investigator: Anna S Islind, PhD, Reykjavik University; Principal Investigator: Steinunn G Sigurðardóttir, MSc, Reykjavik University

Study record dates

Study Major Dates

• Study Start (Estimated): November 10, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Bipolar Disorder; Behavioural Activation; Bipolar depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Depression; Depressive Disorder; Bipolar Disorder
• Other Study ID Numbers: BD0323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data that underlie results in a publication
• IPD Sharing Time Frame: Access will be possible from the date of publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No