Health Trials

Behavioural Activation for Bipolar Depression

ConditionBipolar Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReykjavik University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

10 Participants
are divided into 4 treatment groups
Group A: 2 week waitOther 1 intervention
Group B: 3 week waitOther 1 intervention
Group C: 4 week waitOther 1 intervention
Group D: 5 week waitOther 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
through study completion, an average of 7 months
2

Therapy uptake rate

Number of participants randomised who attend at least 1 treatment session

Time frame
through study completion, an average of 7 months
3

Therapy completion rate

Proportion of participants that attend at least 8 treatment sessions

Time frame
through study completion, an average of 7 months
4

Change in activity levels as measured by consumer connected health devices

Measures of activity levels as by Withings health devices

Time frame
through study completion, an average of 7 months

Secondary outcomes

1

Altman Self-Rating Mania Scale (ASRM)

5 item self-report measure of hypomania symptoms over the past week

Time frame
1 week
2

Work and Social Adjustment Scale (WSAS)

5 item self-report scale of functional impairment attributable to an identified problem

Time frame
24 hours
3

Hamilton Depression Scale (HAM-D)

17 item observer-rated scale measuring symptoms of depression over the past week

Time frame
1 week
4

Brief Quality of Life in Bipolar Disorder (Brief QoLBD)

12 item self-report measure of disorder-specific quality of life

Time frame
1 week

Other outcomes

Sponsors and contacts

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Reykjavik University

Lead sponsor

Landspitali University Hospital

Collaborator

Source ClinicalTrials.gov
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