{"protocolSection":{"identificationModule":{"nctId":"NCT00149825","orgStudyIdInfo":{"id":"R21MH066131","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R21MH066131"},"secondaryIdInfos":[{"id":"R21MH066131","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R21MH066131"},{"id":"DSIR 83-ATAS"}],"organization":{"fullName":"Stanford University","class":"OTHER"},"briefTitle":"Combining Antidepressant Medication and Psychotherapy for Insomnia to Improve Depression Outcome"},"statusModule":{"statusVerifiedDate":"2014-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2004-06"},"primaryCompletionDateStruct":{"date":"2007-08","type":"ACTUAL"},"completionDateStruct":{"date":"2007-08","type":"ACTUAL"},"studyFirstSubmitDate":"2005-09-06","studyFirstSubmitQcDate":"2005-09-07","studyFirstPostDateStruct":{"date":"2005-09-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2009-07-30","resultsFirstSubmitQcDate":"2009-09-11","resultsFirstPostDateStruct":{"date":"2009-10-14","type":"ESTIMATED"},"lastUpdateSubmitDate":"2014-05-12","lastUpdatePostDateStruct":{"date":"2014-05-20","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Rachel Manber","investigatorTitle":"Dr. Rachel Manber","investigatorAffiliation":"Stanford University"},"leadSponsor":{"name":"Stanford University","class":"OTHER"},"collaborators":[{"name":"National Institute of Mental Health (NIMH)","class":"NIH"}]},"descriptionModule":{"briefSummary":"This study will examine the effectiveness of a combination of antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.","detailedDescription":"Difficulties falling and/or staying asleep are common in people who suffer from depression. Persistent insomnia can hinder response to treatment. In addition, individuals whose insomnia does not resolve with standard antidepressant therapy are at increased risk for recurrence of their depression. Between 60% and 84% of people who have major depressive disorder report symptoms of insomnia. This study will assess the efficacy of combining antidepressant medication and sleep-focused psychotherapy to simultaneously treat sleep difficulties and depression.\n\nParticipants in this double-blind study will be randomly assigned to receive either desensitization therapy or cognitive behavioral therapy to target insomnia. All participants will also receive escitalopram oxalate, an antidepressant medication. The study will last 12 weeks. The severity of participants' depression and insomnia will be assessed. Study visits will occur weekly for the first 6 weeks, bi-weekly for the last 6 weeks, and once 6 months post-intervention."},"conditionsModule":{"conditions":["Major Depressive Disorder","Insomnia"],"keywords":["Major Depressive Disorder","Insomnia","Sleep","Mental Health"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"TRIPLE","whoMasked":["PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":30,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"MED+CBTI","type":"EXPERIMENTAL","description":"Escitalopram plus Cognitive Behavioral Therapy for Insomnia","interventionNames":["Drug: Escitalopram","Behavioral: CBTI"]},{"label":"MED+CTRL","type":"ACTIVE_COMPARATOR","description":"Escitalopram plus Pseudo-desensitization Therapy for Insomnia","interventionNames":["Drug: Escitalopram","Behavioral: CTRL"]}],"interventions":[{"type":"DRUG","name":"Escitalopram","description":"5 to 20 mg for 12 weeks","armGroupLabels":["MED+CBTI","MED+CTRL"],"otherNames":["Escitalopram plus Cognitive behavioral Therapy","Escitalopram plus Pseudo-desensitization Therapy"]},{"type":"BEHAVIORAL","name":"CBTI","description":"Cognitive Behavioral Treatment for Insomnia","armGroupLabels":["MED+CBTI"],"otherNames":["Cognitive Behavioral Treatment for Insomnia"]},{"type":"BEHAVIORAL","name":"CTRL","description":"Control Therapy consists of Pseudo-desensitization Therapy for Insomnia","armGroupLabels":["MED+CTRL"],"otherNames":["Pseudo-desensitization Therapy for Insomnia"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Remission of Depression (%)","description":"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.\n\nThe HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.\n\nThe SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).","timeFrame":"After 12 weeks or at the last available time point"}],"secondaryOutcomes":[{"measure":"Remission of Insomnia","description":"Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score \\< 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score \\< 8 indicates absence of insomnia.","timeFrame":"After 12 weeks or at the last available time point"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Diagnosis of major depressive disorder\n* HRSD(17) score of at least 14\n* Presence and complaint of insomnia for at least 1 month\n* Fluent in English\n* Use of an effective form of contraception throughout the study\n\nExclusion Criteria:\n\n* Other psychiatric disorders (e.g., bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, eating disorder)\n* Psychotic symptoms\n* Serious, unstable, or terminal medical condition\n* Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder\n* Substance abuse\n* Not willing to end other psychiatric treatment\n* Previous electroconvulsive therapy or vagus nerve stimulation treatment during the last year\n* Sleep apnea, restless leg, or periodic limb movement disorder (to be ruled out after first sleep study)\n* Other sleep disorders\n* Currently pregnant or breastfeeding\n* History of seizure disorder\n* Disease or condition that produces altered metabolism or hemodynamic responses\n* Liver or kidney dysfunction\n* Current use of any over the counter medications or herbs for mood or sleep benefits (e.g., melatonin, valerian, kava, hop extract, St. John's Wort, SAMe)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"75 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Rachel Manber, PhD","affiliation":"Stanford University Medical School, Department of Psychiatry and Behavioral Sciences","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Stanford University","city":"Palo Alto","state":"California","zip":"94304","country":"United States","geoPoint":{"lat":37.44188,"lon":-122.14302}}]},"referencesModule":{"references":[{"pmid":"19616140","type":"BACKGROUND","citation":"Ong JC, Gress JL, San Pedro-Salcedo MG, Manber R. Frequency and predictors of obstructive sleep apnea among individuals with major depressive disorder and insomnia. J Psychosom Res. 2009 Aug;67(2):135-41. doi: 10.1016/j.jpsychores.2009.03.011. Epub 2009 Apr 25."},{"pmid":"18457236","type":"RESULT","citation":"Manber R, Edinger JD, Gress JL, San Pedro-Salcedo MG, Kuo TF, Kalista T. Cognitive behavioral therapy for insomnia enhances depression outcome in patients with comorbid major depressive disorder and insomnia. Sleep. 2008 Apr;31(4):489-95. doi: 10.1093/sleep/31.4.489."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"Enrolled participants were screened to determine if inclusion exclusion criteria were met. This process included structured clinical interviews, completion of sleep logs, and an ambulatory screening sleep study to rule out other sleep disorders.","recruitmentDetails":"Participants were recruited between June 2004 and August 2006 through newspaper advertisements, electronic bulletin boards, community postings, and brochures in clinics.","groups":[{"id":"FG000","title":"MED+CBTI","description":"Escitalopram plus cognitive behavioral therapy for insomnia"},{"id":"FG001","title":"MED+CTRL","description":"Escitalopram plus control therapy for insomnia in depression"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"},{"groupId":"FG001","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"12"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"3"}]}],"dropWithdraws":[{"type":"Intolerance to medication side effects","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"}]},{"type":"Time commitments","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Not liking insomnia therapy","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]},{"type":"Other","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"MED+CBTI","description":"Escitalopram plus cognitive behavioral therapy for insomnia"},{"id":"BG001","title":"MED+CTRL","description":"Escitalopram plus control therapy for insomnia in depression"},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"14"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"27"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"3"}]}]}]},{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"49.5","spread":"13.6"},{"groupId":"BG001","value":"47.8","spread":"13.4"},{"groupId":"BG002","value":"48.6","spread":"13.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"19"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"15"},{"groupId":"BG002","value":"30"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Remission of Depression (%)","description":"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.\n\nThe HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.\n\nThe SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains).","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent of participants","timeFrame":"After 12 weeks or at the last available time point","groups":[{"id":"OG000","title":"MED+CBTI","description":"Escitalopram plus cognitive behavioral therapy for insomnia"},{"id":"OG001","title":"MED+CTRL","description":"Escitalopram plus control therapy for insomnia in depression"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"61.5"},{"groupId":"OG001","value":"33.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"We hypothesized that compared with MED+CTRL, a greater percent of participants randomized to MED+CBTI will experience remission of depression","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".13","statisticalMethod":"Chi-squared","statisticalComment":"This is a one-tailed test","ciPctValue":"95"}]},{"type":"SECONDARY","title":"Remission of Insomnia","description":"Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score \\< 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score \\< 8 indicates absence of insomnia.","populationDescription":"Included in the analysis were all participants who attended at least one post randomization visit.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percent","timeFrame":"After 12 weeks or at the last available time point","groups":[{"id":"OG000","title":"MED+CBTI","description":"Escitalopram plus cognitive behavioral therapy for insomnia"},{"id":"OG001","title":"MED+CTRL","description":"Escitalopram plus control therapy for insomnia in depression"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"13"},{"groupId":"OG001","value":"15"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"50.0"},{"groupId":"OG001","value":"7.7"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"We hypothesized that compared with MED+CTRL, a greater percent of participants in MED+CBTI will experience remission of insomnia.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":".05","statisticalMethod":"Chi-squared","ciPctValue":"95"}]}]},"adverseEventsModule":{"frequencyThreshold":"5","eventGroups":[{"id":"EG000","title":"MED+CBTI","description":"Escitalopram plus cognitive behavioral therapy for insomnia","seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG001","title":"MED+CTRL","description":"Escitalopram plus control therapy for insomnia in depression","seriousNumAffected":0,"seriousNumAtRisk":0,"otherNumAffected":0,"otherNumAtRisk":15}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Limitations of the current pilot study include a small sample size, relative racial homogeneity, and exclusion of patients with comorbidity."},"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Rachel Manber, PhD","organization":"Stanford University, School of Medicine","email":"Rmanber@stanford.edu","phone":"650-724-2377"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D003865","term":"Depressive Disorder, Major"},{"id":"D007319","term":"Sleep Initiation and Maintenance Disorders"},{"id":"D000092862","term":"Psychological Well-Being"}],"ancestors":[{"id":"D003866","term":"Depressive Disorder"},{"id":"D019964","term":"Mood Disorders"},{"id":"D001523","term":"Mental Disorders"},{"id":"D020919","term":"Sleep Disorders, Intrinsic"},{"id":"D020920","term":"Dyssomnias"},{"id":"D012893","term":"Sleep Wake Disorders"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D010549","term":"Personal Satisfaction"},{"id":"D001519","term":"Behavior"}]},"interventionBrowseModule":{"meshes":[{"id":"D000089983","term":"Escitalopram"},{"id":"D015928","term":"Cognitive Behavioral Therapy"}],"ancestors":[{"id":"D011437","term":"Propylamines"},{"id":"D000588","term":"Amines"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D009570","term":"Nitriles"},{"id":"D001572","term":"Benzofurans"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D001521","term":"Behavior Therapy"},{"id":"D011613","term":"Psychotherapy"},{"id":"D004191","term":"Behavioral Disciplines and Activities"}]}},"hasResults":true}