Bipolar DepressionNCT06022913
Behavioural Activation for Bipolar Depression
A study testing Behavioural Activation (BA) in people with Bipolar Depression, run by Reykjavik University at 1 site in Iceland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Behavioural Activation (BA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIceland
- Study dates
- 22 Nov 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali university hospital
Reykjavik, 101
Halla Ó Ólafsdóttir, Cand. psych, 003548688371, hallaosh@landspitali.is
Brynja B Magnúsdóttir, PhD, cand psych, 003548489685, brynjabm@ru.is
About this study
Official title: 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.
Read more
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.
- Conditions
- Bipolar Depression
- Being tested
- Behavioural Activation (BA)
- Keywords
- Bipolar depression, Bipolar Disorder, Behavioural Activation, Depression
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural Activation (BA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 week wait | Other | Participant waits for 2 weeks after their baseline assessment before commencing therapy. Receives: Behavioral: Behavioural Activation (BA) |
| 3 week wait | Other | Participant waits for 3 weeks after their baseline assessment before commencing therapy. Receives: Behavioral: Behavioural Activation (BA) |
| 4 week wait | Other | Participant waits for 4 weeks after their baseline assessment before commencing therapy. Receives: Behavioral: Behavioural Activation (BA) |
| 5 week wait | Other | Participant waits for 5 weeks after their baseline assessment before commencing therapy. Receives: Behavioral: Behavioural Activation (BA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%)
Participants' weekly completion of the Patient Health Questionnaire-9 (PHQ-9)
Measured: through study completion, an average of 7 months
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Measured: through study completion, an average of 7 months
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Measured: 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
Measured: through study completion, an average of 7 months
Change in Sleep Duration measured by health device
Measures of sleep duration by Withings health devices
Measured: through study completion, an average of 7 months
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists
Measured: through study completion, an average of 7 months
Secondary outcomes (11)
Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Measured: 1 week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Measured: 24 hours
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Measured: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
Measured: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Measured: 2 weeks
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Measured: 1 week
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Measured: 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
Measured: Six months
Young mania rating scale
11 item observer-rated scale measuring the severity of manic states
Measured: 48 hours
Six daily questions
Six daily questions in mobile about goal achievement, mood, sleep etc
Measured: 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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start22 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reykjavik University
- Sponsor type
- University, hospital or other
- Collaborators
- Landspitali University Hospital
- Responsible party
- Principal investigator, Brynja Bjork Magnusdottir, Reykjavik University
- Investigators
- Brynja B Magnúsdóttir, PhD, Study chair, Reykjavik UniversityAnna S Islind, PhD, Principal investigator, Reykjavik UniversitySteinunn G Sigurðardóttir, MSc, Principal investigator, Reykjavik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022913
- Sponsor's protocol ID
- BD0323
- Status last verified
- Apr 2025
- First submitted
- 28 Aug 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)
- ClinicalTrials.gov ID
- NCT06022913
- Acronym / sponsor ID
- BD0323
- Conditions
- Bipolar Depression
- Keywords
- Bipolar depression, Bipolar Disorder, Behavioural Activation, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Reykjavik UniversityUniversity, hospital or other
- Collaborators
- Landspitali University Hospital
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 2 week wait | Other | Behavioral: Behavioural Activation (BA)Participant waits for 2 weeks after their baseline assessment before commencing therapy. |
| 3 week wait | Other | Behavioral: Behavioural Activation (BA)Participant waits for 3 weeks after their baseline assessment before commencing therapy. |
| 4 week wait | Other | Behavioral: Behavioural Activation (BA)Participant waits for 4 weeks after their baseline assessment before commencing therapy. |
| 5 week wait | Other | Behavioral: Behavioural Activation (BA)Participant waits for 5 weeks after their baseline assessment before commencing therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | 2 week wait, 3 week wait, 4 week wait, 5 week wait |
Primary outcome
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)
Therapy uptake rate
Time frame: through study completion, an average of 7 months
Number of participants randomised who attend at least 1 treatment session
Therapy completion rate
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 7 months
Measures of sleep duration by Withings health devices
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
11 secondary outcomes
Altman Self-Rating Mania Scale (ASRM)
Time frame: 1 week
Work and Social Adjustment Scale (WSAS)
Time frame: 24 hours
Hamilton Depression Scale (HAM-D)
Time frame: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
Time frame: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
Time frame: 2 weeks
Behavioral Activation for Depression Scale (BADS)
Time frame: 1 week
Snaith-Hamilton Pleasure Scale (SHAPS)
Time frame: 1 week
Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)
Time frame: Six months
Young mania rating scale
Time frame: 48 hours
Six daily questions
Time frame: 24 hours
The Quality of Behavioral Activation Scale (Q-BAS)
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. All data that underlie results in a publication
Related trials for Bipolar Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 4
Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)
Depression, Bipolar
Recruiting
HD-tDCS for Adolescent Bipolar Depression Targeting S1
Adolescent, Bipolar Depression
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brynja B Magnúsdóttir, PhD study chair
Reykjavik University
Anna S Islind, PhD principal investigator
Reykjavik University
Steinunn G Sigurðardóttir, MSc principal investigator
Reykjavik University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural Activation (BA) in people with Bipolar Depression, run by Reykjavik University at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Halla Ó Ólafsdóttir, Cand. psych (8688371, hallaosh@landspitali.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimally clinically significant improvement in depression symptoms for a majority of participants (>60%) (time frame: through study completion, an average of 7 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.