An interventional study of Behavioural Activation (BA) in Bipolar Depression, sponsored by Reykjavik University. Recruiting at 1 site in Iceland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Reykjavik University · Not applicable, Interventional, and Treatment
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 10 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Reykjavik University is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participant waits for 2 weeks after their baseline assessment before commencing therapy.
Behavioral: Behavioural Activation (BA)
Participant waits for 3 weeks after their baseline assessment before commencing therapy.
Behavioral: Behavioural Activation (BA)
Participant waits for 4 weeks after their baseline assessment before commencing therapy.
Behavioral: Behavioural Activation (BA)
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.
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
Therapy uptake rate
Number of participants randomised who attend at least 1 treatment session
Time frame: through study completion, an average of 7 months
Therapy completion rate
Proportion of participants that attend at least 8 treatment sessions
Time frame: 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
Time frame: through study completion, an average of 7 months
Change in Sleep Duration measured by health device
Measures of sleep duration by Withings health devices
Time frame: through study completion, an average of 7 months
No significant adverse reaction for participants
Participant reports of adverse events elicited by researchers and therapists
Time frame: through study completion, an average of 7 months
Altman Self-Rating Mania Scale (ASRM)
5 item self-report measure of hypomania symptoms over the past week
Time frame: 1 week
Work and Social Adjustment Scale (WSAS)
5 item self-report scale of functional impairment attributable to an identified problem
Time frame: 24 hours
Hamilton Depression Scale (HAM-D)
17 item observer-rated scale measuring symptoms of depression over the past week
Time frame: 1 week
Brief Quality of Life in Bipolar Disorder (Brief QoLBD)
12 item self-report measure of disorder-specific quality of life
Time frame: 1 week
General Anxiety Disorder Assessment - 7 (GAD7)
7 item self-report measure of anxiety symptoms
Time frame: 2 weeks
Behavioral Activation for Depression Scale (BADS)
25 item self-report measure of changes in activation and avoidance over the past week
Time frame: 1 week
Snaith-Hamilton Pleasure Scale (SHAPS)
14 item self-report measure of level of anhedonia
Time frame: 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
Time frame: Six months
Young mania rating scale
11 item observer-rated scale measuring the severity of manic states
Time frame: 48 hours
Six daily questions
Six daily questions in mobile about goal achievement, mood, sleep etc
Time frame: 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
Time frame: 1 week
Plan to share: Yes — All data that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Access will be possible from the date of publication.
Access criteria: The dataset will be anonymous and registered with a metadata-only record, allowing the research team to control access to the dataset, and restricting it to appropriately qualified third parties.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Reykjavik University