[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611376":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":42,"responsibleParty":108,"collaborators":112,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":26,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":147,"whyStopped":26,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":153,"leadSponsor":155,"locationsCount":156},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAU: Traditional group psychoeducation for bipolar disorder","ACTIVE_COMPARATOR","Traditional GPP for bipolar disorder consists of 11 group sessions led by one or two trained therapists. The sessions comprise predefined topics such as the characteristics of BD, theories about etiology, managing depression and mania, psychopharmacological treatment, and lifestyle advice to enhance illness stabilization. Each session has an introductory lecture on the topic held by the therapist, small-group discussions based on the participants' experiences in this area, and plenary discussions led by the therapist. The program also provides written material for the participants to read and prepare for the relevant session, provided in a booklet. It contains the educational parts, a toolkit with a mood diary, an overview of potential \"warning signs\" for relapse, and an emergency plan. The toolkit is used to engage the participants in self-management of the disorder.",[13],"Behavioral: Traditional group psychoeducation for bipolar disorder",{"label":15,"type":16,"description":17,"interventionNames":18},"PEDAL: Group psychoeducation with digital elements and focus on affective lability","EXPERIMENTAL","The PEDAL arm provides the 11 group sessions as described for the comparator arm, and two additional sessions that have been developed for the trial to cover topics related to affective lability and emotion regulation. Thus, in this arm there will be 13 group sessions. The format of the sessions is the same as for the TAU arm. In addition, participants in this arm will have access to an online platform with the following content: All written course material, three video tutorials for emotion regulation skills training, and an app-based mood diary that provides a dashboard where participants can monitor their mood and sleep patterns.",[19],"Behavioral: Group psychoeducation with digital elements and focus on affective lability",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Traditional group psychoeducation for bipolar disorder","Psychosocial intervention",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":30},"Group psychoeducation with digital elements and focus on affective lability",[15],[31],"The PEDAL intervention",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Trine V. Lagerberg, Professor","CONTACT","+47 22 92 35 01","t.v.lagerberg@psykologi.uio.no",{"name":39,"role":35,"phone":40,"phoneExt":26,"email":41},"Margrethe C. Høegh, PhD","+47 23 02 73 30","machoe@ous-hf.no",[43,64,82,93],{"facility":44,"status":26,"city":45,"state":26,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Vestre Viken Hospital Trust (Drammen DPS)","Drammen","3018","Norway","NO",{"type":50,"coordinates":51},"Point",[52,53],10.20449,59.74389,{"lat":53,"lon":52},[56,60],{"name":57,"role":35,"phone":58,"phoneExt":26,"email":59},"Irene Norheim, Occupational therapist","+47 32 86 18 00","Irene.Norheim@vestreviken.no",{"name":61,"role":35,"phone":62,"phoneExt":26,"email":63},"Lena W. Molteberg, Head of Section","+ 47 32 86 18 00","LenaWicklund.Molteberg@vestreviken.no",{"facility":65,"status":26,"city":66,"state":26,"zip":67,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Oslo University Hospital (Nydalen DPS and Søndre Oslo DPS)","Oslo","0351",{"type":50,"coordinates":69},[70,71],10.74609,59.91273,{"lat":71,"lon":70},[74,78],{"name":75,"role":35,"phone":76,"phoneExt":26,"email":77},"Erlend Eikenæs, Cand.psychol","+47 23 02 33 00","erleik@ous-hf.no",{"name":79,"role":35,"phone":80,"phoneExt":26,"email":81},"Hanne Vørrang, Psychiatric nurse","+47 23 02 30 00","hanvor@ous-hf.no",{"facility":83,"status":26,"city":66,"state":26,"zip":84,"country":47,"countryCode":48,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"Diakonhjemmet Hospital (Allmennpsykiatrisk poliklinikk)","0373",{"type":50,"coordinates":86},[70,71],{"lat":71,"lon":70},[89],{"name":90,"role":35,"phone":91,"phoneExt":26,"email":92},"Marcus Gabrielsen, Cand.med.","+47 22 02 98 00","marcus.gabrielsen@diakonsyk.no",{"facility":94,"status":26,"city":66,"state":26,"zip":95,"country":47,"countryCode":48,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Lovisenberg Diaconal Hospital (Section for Group Treatment)","0440",{"type":50,"coordinates":97},[70,71],{"lat":71,"lon":70},[100,104],{"name":101,"role":35,"phone":102,"phoneExt":26,"email":103},"Helle Jannecke Elvebredd, Psychotherapist\u002Fsection head","+47 23 22 50 00","hellejanecke.elvebredd@lds.no",{"name":105,"role":35,"phone":106,"phoneExt":26,"email":107},"Jan Vegard Bakali, PhD","+ 47 23 22 50 00","jan-vegard.bakali@lds.no",{"type":109,"investigatorFullName":110,"investigatorTitle":111,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Trine Vik Lagerberg","Professor",[113,115,117],{"name":114,"class":6},"Vestre Viken Hospital Trust",{"name":116,"class":6},"Diakonhjemmet Hospital",{"name":118,"class":6},"Lovisenberg Diakonale Hospital","100611376","phase-2-the-pedal-intervention---reducing-affective-lability-in-bipolar-disorder-100611376",false,"NCT07239778","The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder","The PEDAL Intervention - Reducing Affective Lability in Bipolar Disorder - a Randomised Controlled Trial","PEDAL","Inclusion Criteria:\n\n* Bipolar I, II or not otherwise specified disorder\n* Understands Scandinavian language\n* Owns and will use smartphone as part of the intervention\n* Is considered eligible for group participation by treating clinician\n\nExclusion Criteria:\n\n* Previous participation in group psychoeducation for bipolar disorder\n* Will move, is late in pregnancy or other situation that prevents competion of trial","ALL","18 Years","65 Years",{"count":131,"type":132},120,"ESTIMATED","INTERVENTIONAL",[135],"PHASE2","PEDAL is a group-based intervention for patients with bipolar disorder that builds on the traditional group psychoeducational program (GPP) by adding digital tools and specific strategies to help manage rapid fluctuations between affective states, known as affective lability. The program's goal is to help patients learn and develop new ways to better manage their condition, with particular attention to affective lability and other difficulties with affect regulation- challenges which are not typically addressed in current treatments.\n\nThe PEDAL trial will run at five clinical sites around Oslo and Vestre Viken, aiming to recruit 120 participants with bipolar disorder. The program combines existing group sessions from GPP with new components: additional group sessions focusing on strategies for improving affect regulation such as mindfulness and distress tolerance, an online platform with all course materials including instructional videos and other resources, and an app-based mood diary. This framework maintains the benefits of regular group meetings while adding digital support tools to make the intervention more personalized and accessible.\n\nThe main aim of PEDAL is to see if the new program reduces affective lability more effectively than GPP (treatment-as-usual; TAU), and both intervention groups will be compared on the level of affective lability before and after the intervention. Several secondary outcomes like mood symptoms, suicidal thoughts, perceived stress, and quality of life will also be assessed. In terms of study design, all study sites will run the PEDAL and TAU groups in parallel, and participants will be randomly assigned to either PEDAL or TAU.\n\nTo qualify for the study, participants must be aged 18-65, diagnosed with bipolar disorder, able to participate in a group intervention, capable of providing informed consent, and have a smartphone or computer. People who have previously completed group psychoeducation, who are unable to complete the study period due to pregnancy or other factors, or those who cannot use the required technology are excluded.\n\nIn summary, PEDAL is a novel study that modernizes the existing group psychoeducational program for bipolar disorder by targeting affective lability through skills training and digital tools, while also evaluating its reception and effects in a controlled clinical trial.",[138],"Bipolar Disorder (BD)",[140,141,142,143,144,145,146],"Affective lability","Bipolar disorder","Psychoeducation","Group intervention","Emotion regulation","Digital tools","eHealth","NOT_YET_RECRUITING","2025-11-20",{"date":150,"type":151},"2025-11-25","ACTUAL",{"date":150,"type":132},{"date":154,"type":132},"2026-12",{"name":5,"class":6},4]