Behavioural Activation for Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022913
• Other study ID #: BD0323
• Status: Recruiting
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Reykjavik University
• Contact: Halla Ó Ólafsdóttir, Cand. psych
• Phone: 8688371
• Email: hallaosh[@]landspitali.is
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Iceland	Landspitali university hospital	Reykjavík

Sponsors (2)

Lead Sponsor	Collaborator
Reykjavik University	Landspitali University Hospital

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Therapy uptake rate	Number of participants randomised who attend at least 1 treatment session	through study completion, an average of 7 months
Primary	Therapy completion rate	Proportion of participants that attend at least 8 treatment sessions	through study completion, an average of 7 months
Primary	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
Primary	Change in Sleep Duration measured by health device	Measures of sleep duration by Withings health devices	through study completion, an average of 7 months
Primary	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	Altman Self-Rating Mania Scale (ASRM)	5 item self-report measure of hypomania symptoms over the past week	1 week
Secondary	Work and Social Adjustment Scale (WSAS)	5 item self-report scale of functional impairment attributable to an identified problem	24 hours
Secondary	Hamilton Depression Scale (HAM-D)	17 item observer-rated scale measuring symptoms of depression over the past week	1 week
Secondary	Brief Quality of Life in Bipolar Disorder (Brief QoLBD)	12 item self-report measure of disorder-specific quality of life	1 week
Secondary	General Anxiety Disorder Assessment - 7 (GAD7)	7 item self-report measure of anxiety symptoms	2 weeks
Secondary	Behavioral Activation for Depression Scale (BADS)	25 item self-report measure of changes in activation and avoidance over the past week	1 week
Secondary	Snaith-Hamilton Pleasure Scale (SHAPS)	14 item self-report measure of level of anhedonia	1 week
Secondary	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
Secondary	Young mania rating scale	11 item observer-rated scale measuring the severity of manic states	48 hours
Secondary	Six daily questions	Six daily questions in mobile about goal achievement, mood, sleep etc	24 hours
Secondary	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