Behavioural Activation for Bipolar Depression

Sponsor

Reykjavik University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06022913

Collaborator

Landspitali University Hospital (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Depression	Behavioral: Behavioural Activation (BA)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) [through study completion, an average of 7 months]
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Therapy uptake rate [through study completion, an average of 7 months]
Number of participants randomised who attend at least 1 treatment session
Therapy completion rate [through study completion, an average of 7 months]
Proportion of participants that attend at least 8 treatment sessions
Change in activity levels as measured by consumer connected health devices [through study completion, an average of 7 months]
Measures of activity levels as by Withings health devices
Change in Sleep Duration measured by health device [through study completion, an average of 7 months]
Measures of sleep duration by Withings health devices
No significant adverse reaction for participants [through study completion, an average of 7 months]
Participant reports of adverse events elicited by researchers and therapists

Secondary Outcome Measures

Altman Self-Rating Mania Scale (ASRM) [1 week]
5 item self-report measure of hypomania symptoms over the past week
Work and Social Adjustment Scale (WSAS) [24 hours]
5 item self-report scale of functional impairment attributable to an identified problem
Hamilton Depression Scale (HAM-D) [1 week]
17 item observer-rated scale measuring symptoms of depression over the past week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD) [1 week]
12 item self-report measure of disorder-specific quality of life
General Anxiety Disorder Assessment - 7 (GAD7) [2 weeks]
7 item self-report measure of anxiety symptoms
Behavioral Activation for Depression Scale (BADS) [1 week]
25 item self-report measure of changes in activation and avoidance over the past week
Snaith-Hamilton Pleasure Scale (SHAPS) [1 week]
14 item self-report measure of level of anhedonia
Mini International Neuropsychiatric Interview (MINI) 7.0.2 [Six months]
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
Young mania rating scale [48 hours]
11 item observer-rated scale measuring the severity of manic states
Six daily questions [24 hours]
Six daily questions in mobile about goal achievement, mood, sleep etc
The Quality of Behavioral Activation Scale (Q-BAS) [1 week]
To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 Mini International Neuropsychiatric Interview (MINI) 7.0.2 meeting diagnostic criteria for Bipolar I or II Disorder (MINI) 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)