[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517851":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":67,"studyPopulation":67,"armGroups":76,"interventions":94,"overallOfficials":100,"centralContacts":109,"locations":119,"responsibleParty":139,"collaborators":142,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":67,"eligibilityCriteria":151,"healthyVolunteers":147,"sex":152,"minAge":153,"maxAge":67,"enrollmentInfo":154,"targetDuration":67,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":122,"whyStopped":67,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"Reykjavik University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":67},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"Therapy uptake rate","Number of participants randomised who attend at least 1 treatment session",{"measure":17,"description":18,"timeFrame":12},"Therapy completion rate","Proportion of participants that attend at least 8 treatment sessions",{"measure":20,"description":21,"timeFrame":12},"Change in activity levels as measured by consumer connected health devices","Measures of activity levels as by Withings health devices",{"measure":23,"description":24,"timeFrame":12},"Change in Sleep Duration measured by health device","Measures of sleep duration by Withings health devices",{"measure":26,"description":27,"timeFrame":12},"No significant adverse reaction for participants","Participant reports of adverse events elicited by researchers and therapists",[29,33,37,40,43,47,50,53,57,61,64],{"measure":30,"description":31,"timeFrame":32},"Altman Self-Rating Mania Scale (ASRM)","5 item self-report measure of hypomania symptoms over the past week","1 week",{"measure":34,"description":35,"timeFrame":36},"Work and Social Adjustment Scale (WSAS)","5 item self-report scale of functional impairment attributable to an identified problem","24 hours",{"measure":38,"description":39,"timeFrame":32},"Hamilton Depression Scale (HAM-D)","17 item observer-rated scale measuring symptoms of depression over the past week",{"measure":41,"description":42,"timeFrame":32},"Brief Quality of Life in Bipolar Disorder (Brief QoLBD)","12 item self-report measure of disorder-specific quality of life",{"measure":44,"description":45,"timeFrame":46},"General Anxiety Disorder Assessment - 7 (GAD7)","7 item self-report measure of anxiety symptoms","2 weeks",{"measure":48,"description":49,"timeFrame":32},"Behavioral Activation for Depression Scale (BADS)","25 item self-report measure of changes in activation and avoidance over the past week",{"measure":51,"description":52,"timeFrame":32},"Snaith-Hamilton Pleasure Scale (SHAPS)","14 item self-report measure of level of anhedonia",{"measure":54,"description":55,"timeFrame":56},"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",{"measure":58,"description":59,"timeFrame":60},"Young mania rating scale","11 item observer-rated scale measuring the severity of manic states","48 hours",{"measure":62,"description":63,"timeFrame":36},"Six daily questions","Six daily questions in mobile about goal achievement, mood, sleep etc",{"measure":65,"description":66,"timeFrame":32},"The Quality of Behavioral Activation Scale (Q-BAS)","To assess the quality of and adherence to BA clinical protocol using audiotapes of therapy sessions",null,{"allocation":69,"interventionModel":70,"interventionModelDescription":71,"primaryPurpose":72,"observationalModel":67,"timePerspective":67,"maskingInfo":73},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":74,"maskingDescription":75,"whoMasked":67},"NONE","It is not possible to blind the assessor to phase or baseline duration of participants in the case-series, as the length of time between assessments will reveal this. Nevertheless, the assessor and clients will be asked not to disclose which therapist is treating them. Use of self-report measures as the primary outcome measure is intended to minimize potential biases on the side of the researcher.",[77,82,86,90],{"label":78,"type":6,"description":79,"interventionNames":80},"2 week wait","Participant waits for 2 weeks after their baseline assessment before commencing therapy.",[81],"Behavioral: Behavioural Activation (BA)",{"label":83,"type":6,"description":84,"interventionNames":85},"3 week wait","Participant waits for 3 weeks after their baseline assessment before commencing therapy.",[81],{"label":87,"type":6,"description":88,"interventionNames":89},"4 week wait","Participant waits for 4 weeks after their baseline assessment before commencing therapy.",[81],{"label":91,"type":6,"description":92,"interventionNames":93},"5 week wait","Participant waits for 5 weeks after their baseline assessment before commencing therapy.",[81],[95],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":67},"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.\n\nThe 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.",[78,83,87,91],[101,104,107],{"name":102,"affiliation":5,"role":103},"Brynja B Magnúsdóttir, PhD","STUDY_CHAIR",{"name":105,"affiliation":5,"role":106},"Anna S Islind, PhD","PRINCIPAL_INVESTIGATOR",{"name":108,"affiliation":5,"role":106},"Steinunn G Sigurðardóttir, MSc",[110,115],{"name":111,"role":112,"phone":113,"phoneExt":67,"email":114},"Halla Ó Ólafsdóttir, Cand. psych","CONTACT","8688371","hallaosh@landspitali.is",{"name":116,"role":112,"phone":117,"phoneExt":67,"email":118},"Brynja Bj Magnúsdóttir, PhD","8489685","brynjabm@ru.is",[120],{"facility":121,"status":122,"city":123,"state":67,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":132,"contacts":133},"Landspitali university hospital","RECRUITING","Reykjavik","101","Iceland","IS",{"type":128,"coordinates":129},"Point",[130,131],-21.89541,64.13548,{"lat":131,"lon":130},[134,136],{"name":111,"role":112,"phone":135,"phoneExt":67,"email":114},"003548688371",{"name":137,"role":112,"phone":138,"phoneExt":67,"email":118},"Brynja B Magnúsdóttir, PhD, cand psych","003548489685",{"type":106,"investigatorFullName":140,"investigatorTitle":141,"investigatorAffiliation":5,"oldNameTitle":67,"oldOrganization":67},"Brynja Bjork Magnusdottir","Assistant professor, Psychologist",[143],{"name":144,"class":6},"Landspitali University Hospital","100517851","behavioural-activation-for-bipolar-depression-100517851",false,"NCT06022913","Behavioural Activation for Bipolar Depression","Adjunctive Behavioural Activation for Bipolar Depression: A Case Series (BA-BD)","Inclusion Criteria:\n\n* 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)\n\nmeeting 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.\n\nExclusion Criteria:\n\n* current\u002Fpast learning disability, organic brain change, substance dependence (drugs and alcohol) that would compromise the ability to use therapy\n* 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.\n* currently lacking the capacity to give informed consent\n* currently receiving other psychosocial therapy for depression or bipolar disorder\n* 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)","ALL","18 Years",{"count":155,"type":156},10,"ESTIMATED","INTERVENTIONAL",[159],"NA","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.\n\nThe 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.\n\nAt 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.\n\nThe study will be a replication study to validate the previous study's findings by Kim, W. et al., 2022 in another setting.",[162],"Bipolar Depression",[164,165,166,167],"Bipolar depression","Bipolar Disorder","Behavioural Activation","Depression","2025-04-11",{"date":170,"type":171},"2025-04-16","ACTUAL",{"date":173,"type":171},"2023-11-22",{"date":175,"type":156},"2025-12-31",{"name":5,"class":6},1]