[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598286":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":87,"studyPopulation":81,"armGroups":88,"interventions":101,"overallOfficials":81,"centralContacts":119,"locations":125,"responsibleParty":139,"collaborators":143,"id":150,"slug":81,"hasResults":151,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":81,"eligibilityCriteria":155,"healthyVolunteers":151,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":81,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":81,"overallStatus":128,"whyStopped":81,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":179},{"fullName":5,"class":6},"Palo Alto Veterans Institute for Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":46},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Posttraumatic Stress Disorder Checklist (PCL-5)","Self-report measure update of the PCL designed to assess PTSD symptoms as defined by the DSM-5. Total scores range from 0-80 (higher scores indicate greater PTSD severity).","Change from baseline through 3 and 6 month follow-up assessment",{"measure":14,"description":15,"timeFrame":16},"Insomnia Severity Index (ISI)","The ISI assesses perceived severity of insomnia. Total scores range from 0-28 (higher scores indicate greater insomnia severity).","Change from baseline through 3 and 6 month follow up",{"measure":18,"description":19,"timeFrame":20},"Nightmare Disorders Index","The NDI is a self-report assessment of nightmare disorder.","Change from baseline through 3 and 6 month assessments",[22,26,29,32,35,39,43],{"measure":23,"description":24,"timeFrame":25},"Clinician Administered PTSD Scale (CAPS-5)","The CAPS-5 is a structured clinical interview that assesses the presence and severity of PTSD symptoms. Total scores range from 0-80 (higher scores indicate greater PTSD severity).","Change from baseline to 1-month follow-up assessment",{"measure":27,"description":28,"timeFrame":25},"Structured Clinical Interview for DSM-5 Sleep Disorders- Revised (SCISD-R)","The SCISD-R is a semi-structured interview designed to obtain a sleep history and screen for certain sleep disorders and diagnose others, including insomnia, hypersomnia, circadian rhythm sleep-wake disorders, sleep-disordered breathing, and parasomnias.",{"measure":30,"description":31,"timeFrame":12},"Generalized Anxiety Disorder Screener (GAD-7)","GAD-7 is a 7-item measure that assesses generalized anxiety symptomology. Total scores range from 0-21 (higher scores indicate greater anxiety).",{"measure":33,"description":34,"timeFrame":12},"Trauma-Related Nightmare Survey (TRNS)","The TRNS assesses nightmare frequency, disturbance, and characteristics",{"measure":36,"description":37,"timeFrame":38},"Depressive Symptoms Index-Suicidality Subscale (DSI-SS)","The DSI-SS is a self-report measure of suicidal ideation, plans, perceived control over ideation, and impulses for suicide. Total scores range from 0-12 (higher scores indicate greater suicidality).","Change from baseline through 3 and 6 month follow up assessment",{"measure":40,"description":41,"timeFrame":42},"Patient Health Questionnaire-9 (PHQ-9)","The PHQ-9 assess the severity of affective and somatic symptoms related to depression; items correspond to the diagnostic criteria for major depression disorder. Total scores range from 0-27 (higher scores indicate greater depressive symptom severity).","Change from baseline through 3 and 6 follow-up assessment",{"measure":44,"description":45,"timeFrame":16},"Brief Inventory of Psychosocial Functioning (B-IPF)","B-IPF is a 7-item measure of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living. Total scores range from 0-42 (higher scores indicate greater functional impairment).",[47,51,55,59,63,67,71,74],{"measure":48,"description":49,"timeFrame":50},"Neuropsychological battery","The Neuropsychological battery draws from the from NIH toolbox Cognitive Battery and is comprised of the following tasks: Picture Vocab, Face Name Associative Memory Exam Test, Flanker Task, Oral Symbol Digit, Picture Sequence, Pattern Comparison, Dimensional Change, and Face Name Associative Memory Exam Delay.","Change from second baseline to 1-month follow-up assessment",{"measure":52,"description":53,"timeFrame":54},"Split Week Self-Assessment of Sleep Survey (SASS-Y)","The SASS-Y measures average bedtime, sleep time, sleep onset latency, number of awakenings, wake time after sleep onset, wake time, out of bedtime and sleep quality.","Change from baseline through 3 and 6 month follow up assessments",{"measure":56,"description":57,"timeFrame":58},"Sleep Diary and Nightmare Log","The Sleep Diary and Nightmare Log assess daily subjective sleep patterns and to inform treatment recommendations.","Change from second baseline through to the end of treatment",{"measure":60,"description":61,"timeFrame":62},"History of Head Injuries","History of Head Injuries is a 3 question screener that assesses for head injury and altered consciousness.","Measured during baseline",{"measure":64,"description":65,"timeFrame":66},"Health Questionnaire","Health Questionnaire measures medical and mental health diagnoses that respondents have received, medical board and disability status, medications taken, and caffeine use","Measured at baseline",{"measure":68,"description":69,"timeFrame":70},"Fitbit Inspire HR data will be downloaded through the Fitabase platform","Fitbit Inspire HR will measure heart rate, physical activity, and nighttime wakefulness.","Change from second baseline through 3 and 6 month follow-up",{"measure":72,"description":73,"timeFrame":54},"Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)","Q-SF is a 16-item measure of life satisfaction and enjoyment in different areas of life over the past week. Total scores range from 14-70 (higher scores indicate greater enjoyment and satisfaction with life).",{"measure":75,"description":76,"timeFrame":77},"Credibility and Expectancy Questionnaire (CEQ)","The CEQ is a 6-item measure that was designed to assess treatment expectancy and rationale credibility for use in clinical outcomes studies","Change from pre-workshop through 1 month follow up",{"allocation":79,"interventionModel":80,"interventionModelDescription":81,"primaryPurpose":82,"observationalModel":81,"timePerspective":81,"maskingInfo":83},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":84,"maskingDescription":81,"whoMasked":85},"SINGLE",[86],"OUTCOMES_ASSESSOR","The aims of the study are:\n\n1. Determine the efficacy of accelerated cognitive behavioral therapy for insomnia and nightmares (CBTi+n) integrated with Written Exposure Therapy (WET) for PTSD for improving insomnia symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.\n2. Determine the efficacy of accelerated CBTi+n integrated with WET for improving nightmare symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.\n\nExploratory Aim: Determine the efficacy of accelerated CBTi+n integrated with WET for improving PTSD symptoms among military personnel with clinically significant symptoms of insomnia, nightmares, and PTSD.",[89,95],{"label":90,"type":91,"description":81,"interventionNames":92},"Written exposure therapy and sleep hygiene for insomnia and nightmares","ACTIVE_COMPARATOR",[93,94],"Behavioral: Written Exposure Therapy (WET)","Behavioral: Sleep Hygiene",{"label":96,"type":97,"description":81,"interventionNames":98},"Written exposure therapy and CBT for insomnia and nightmares","EXPERIMENTAL",[99,100,93],"Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTi)","Behavioral: Cognitive Behavioral Therapy for Nightmares (CBTn)",[102,107,111,115],{"type":103,"name":104,"description":105,"armGroupLabels":106,"otherNames":81},"BEHAVIORAL","Cognitive-Behavioral Therapy for Insomnia (CBTi)","CBTi focuses on stimulus control, eliminating maladaptive coping habits, reducing arousal, and challenging maladaptive thoughts about sleep in an effort to reduce time to fall asleep and time awake during the night.",[96],{"type":103,"name":108,"description":109,"armGroupLabels":110,"otherNames":81},"Cognitive Behavioral Therapy for Nightmares (CBTn)","CBTn involves writing about a distressing or frequent nightmare, rewriting the narrative of the nightmare to target trauma-related themes, and reading the rescripted nightmare narrative.",[96],{"type":103,"name":112,"description":113,"armGroupLabels":114,"otherNames":81},"Written Exposure Therapy (WET)","WET is a trauma-focused intervention in which individuals write about their worst traumatic experience following scripted instruction from the therapist.",[96,90],{"type":103,"name":116,"description":117,"armGroupLabels":118,"otherNames":81},"Sleep Hygiene","Involves reviewing sleep diary data, sleep education, and reviewing and discussing sleep hygiene practices.",[90],[120],{"name":121,"role":122,"phone":123,"phoneExt":81,"email":124},"Carmen McLean, PhD","CONTACT","650-614-9997","carmen.mclean4@va.gov",[126],{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":132,"countryCode":133,"cosmosGeoPoint":81,"geoPoint":81,"contacts":134},"Fort Hood","RECRUITING","Kileen","Texas","76544","United States","US",[135],{"name":136,"role":122,"phone":137,"phoneExt":81,"email":138},"Bryce Williams","210-562-6700","williamsB7@uthscsa.edu",{"type":140,"investigatorFullName":141,"investigatorTitle":142,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"PRINCIPAL_INVESTIGATOR","Carmen McLean","Clinical Psychologist",[144,146,148],{"name":145,"class":6},"The University of Texas Health Science Center at San Antonio",{"name":147,"class":6},"University of Arizona",{"name":149,"class":6},"NDRI-USA, Inc.","100598286",false,"NCT07069517","Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD","Accelerated Treatment for Co-occurring Insomnia, Nightmares, and PTSD: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Defense Enrollment Eligibility Reporting System (DEERS) eligible active-duty military personnel or veteran, 18-65 years old.\n2. Ability to speak and read English.\n3. Clinically significant PTSD symptoms (CAPS-5 \\> 25 with at least one Intrusion symptom and at least one Avoidance symptom).\n4. Clinically significant symptoms of insomnia disorder (Structured Clinical Interview for Sleep Disturbance DSM-5 (SCISD) Insomnia Criteria are met and Insomnia Severity Index (ISI) \\> 11).\n5. Nightmares \\> 1 monthly (as reported on the SCISD).\n6. Willing to refrain from new behavioral health or medication treatment for issues pertaining to PTSD, sleep, and nightmares during study participation.\n\nExclusion Criteria:\n\n1. Current suicide or homicide risk meriting crisis intervention.\n2. Inability to comprehend the baseline screening questionnaires.\n3. Unwilling to remain abstinent from alcohol during therapy sessions.\n4. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate clinical attention based on interviewer assessment and clinical judgement.\n5. Currently engaged in evidence-based psychotherapy for PTSD (e.g., Prolonged Exposure Therapy, Cognitive Processing Therapy, Written Exposure Therapy) or insomnia or nightmares (e.g., Cognitive Behavioral Therapy for Insomnia or Nightmares).\n6. Pregnancy, as determined by self-report, because pregnancy can adversely affect sleep outside of PTSD, insomnia, and nightmares.\n7. Working duty shifts ending later than 21:00 or starting before 05:30 more than 2 times per month.","ALL","18 Years","65 Years",{"count":160,"type":161},160,"ESTIMATED","INTERVENTIONAL",[164],"NA","This study is a two-arm individually randomized group treatment clinical trial evaluating behavioral therapies for insomnia, nightmares, and PTSD. The study will compare cognitive-behavioral therapy for insomnia and nightmares to sleep hygiene (Control), both integrated with Written Exposure Therapy for PTSD and delivered in an accelerated (i.e., 5-day) group treatment format, preceded and followed by individual treatment sessions. 160 participants will be randomized into one of two study conditions.",[167,168,169],"Insomnia","PTSD - Post Traumatic Stress Disorder","Nightmares","2025-12-01",{"date":172,"type":173},"2025-12-03","ACTUAL",{"date":175,"type":161},"2025-12-02",{"date":177,"type":161},"2028-12-01",{"name":5,"class":6},1]