[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100227718":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":24,"studyPopulation":17,"armGroups":25,"interventions":32,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":73,"collaborators":17,"id":76,"slug":17,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":17,"enrollmentInfo":85,"targetDuration":17,"studyType":88,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":55,"whyStopped":17,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Tulsa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Past Week Nightmare Frequency","This fill-in-the-blank variable assesses the number of nightmares experienced in the past week (range = 0 - X nightmares) at each assessment (baseline, one week following treatment, and three months following treatment). Higher values indicate more nightmares (worse outcome).","Pre, One week, Three Months",[14],{"measure":15,"description":16,"timeFrame":12},"Change in Clinician Administered PTSD Scale Symptoms","This semi-structured clinical interview assesses severity of each of 30 items",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"NA","SINGLE_GROUP","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":17},"NONE","This pilot study will examine the efficacy of Exposure, Relaxation, \\& Rescripting Therapy (ERRT) on chronic nightmares in trauma-exposed adults diagnosed with bipolar disorder (B-ERRT), as these individuals have been excluded from past clinical trials. Eligible participants will be assessed prior to starting treatment. B-ERRT will be conducted once a week for approximately five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics\u002Fskills: psychoeducation regarding trauma, nightmares, and sleep disturbances on bipolar disorder, relaxation techniques, exposure to the trauma-nightmare, and relapse prevention. Participants will then be asked to complete two to three follow-up assessments, 1-week, 3-months, and potentially 1-year after the end of the treatment.",[26],{"label":27,"type":28,"description":29,"interventionNames":30},"Nightmare Treatment","EXPERIMENTAL","The nightmare treatment, Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder (ERRT-Bipolar Disorder), is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.",[31],"Behavioral: ERRT-Bipolar Disorder",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"BEHAVIORAL","ERRT-Bipolar Disorder","The nightmare treatment, called Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder, is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.",[27],[39],"ERRT",[41],{"name":42,"affiliation":5,"role":43},"Joanne L Davis, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":17,"email":48},"CONTACT","9186312875","joanne-davis@utulsa.edu",{"name":50,"role":46,"phone":51,"phoneExt":17,"email":52},"Lucia D Villarreal, MS","9186313976","ldv0460@utulsa.edu",[54],{"facility":5,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Tulsa","Oklahoma","74104","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-95.99277,36.15398,{"lat":65,"lon":64},[68,70,72],{"name":42,"role":46,"phone":69,"phoneExt":17,"email":48},"918-631-3976",{"name":50,"role":46,"phone":71,"phoneExt":17,"email":52},"918-379-0426",{"name":42,"role":43,"phone":17,"phoneExt":17,"email":17},{"type":43,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Joanne Davis","PI","100227718",false,"NCT02242110","Brief Treatment for Trauma Nightmares in Trauma-exposed Adults With Bipolar Disorder","Efficacy of a Brief Treatment for Chronic Nightmares Among Trauma-Exposed Persons With Bipolar Disorder","BERRT","Inclusion Criteria:\n\n* Nightmares at least once per week for the past month\n* Formal diagnosis of Bipolar disorder (I or II)\n* Exposure to traumatic event (1+ months ago)\n* Stable on bipolar medication for at least 2 months\n\nExclusion Criteria:\n\n* A traumatic event within the last month\n* Intellectual disability\n* Current or recent mania\u002Fhypomania within the last 3 months\n* Suicide attempt or hospitalization within the last 3 months\n* Current or untreated substance use disorder within the past 6 months","ALL","18 Years",{"count":86,"type":87},20,"ESTIMATED","INTERVENTIONAL",[19],"Exposure, relaxation, and rescripting therapy (ERRT) is a promising psychological intervention developed to target trauma-related nightmares and sleep disturbances. Though further evidence is needed, ERRT has shown strong support in reducing the number and intensity of nightmares, as well as improving overall sleep quality in both civilian and veteran samples. This study will assess the efficacy in individuals diagnosed with bipolar disorder.",[92,93],"Nightmares","Post-traumatic Stress Disorder",[92,95,96,97],"Sleep","PTSD","Exposure, Relaxation, and Rescripting Therapy","2024-07-01",{"date":100,"type":101},"2024-07-03","ACTUAL",{"date":103,"type":17},"2014-06",{"date":105,"type":87},"2027-05",{"name":5,"class":6},1]