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NCT Number: NCT06022913

Behavioural Activation for Bipolar Depression

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.

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Key information

Conditions

Bipolar Depression Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Depression Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

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

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

  2. Therapy uptake rate

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

    Number of participants randomised who attend at least 1 treatment session

  3. Therapy completion rate

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

    Proportion of participants that attend at least 8 treatment sessions

  4. Change in activity levels as measured by consumer connected health devices

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

    Measures of activity levels as by Withings health devices

  5. Change in Sleep Duration measured by health device

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

    Measures of sleep duration by Withings health devices

  6. No significant adverse reaction for participants

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

    Participant reports of adverse events elicited by researchers and therapists

Secondary outcomes

  1. Altman Self-Rating Mania Scale (ASRM)

    Time frame: 1 week

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

  2. Work and Social Adjustment Scale (WSAS)

    Time frame: 24 hours

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

  3. Hamilton Depression Scale (HAM-D)

    Time frame: 1 week

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

  4. Brief Quality of Life in Bipolar Disorder (Brief QoLBD)

    Time frame: 1 week

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

  5. General Anxiety Disorder Assessment - 7 (GAD7)

    Time frame: 2 weeks

    7 item self-report measure of anxiety symptoms

  6. Behavioral Activation for Depression Scale (BADS)

    Time frame: 1 week

    25 item self-report measure of changes in activation and avoidance over the past week

  7. Snaith-Hamilton Pleasure Scale (SHAPS)

    Time frame: 1 week

    14 item self-report measure of level of anhedonia

  8. Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)

    Time frame: 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

  9. Young mania rating scale

    Time frame: 48 hours

    11 item observer-rated scale measuring the severity of manic states

  10. Six daily questions

    Time frame: 24 hours

    Six daily questions in mobile about goal achievement, mood, sleep etc

  11. The Quality of Behavioral Activation Scale (Q-BAS)

    Time frame: 1 week

    To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions

Study contacts

Contact information is provided by the study sponsor or research team.

Brynja Bj Magnúsdóttir, PhD

CONTACT

[email protected]

8489685

Halla Ó Ólafsdóttir, Cand. psych

CONTACT

[email protected]

8688371

Sponsors and collaborators

Lead sponsor

Reykjavik University

Other

Collaborators

  • Landspitali University Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 5, 2023
Registry last updated
Apr 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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