{"protocolSection":{"identificationModule":{"nctId":"NCT00066937","orgStudyIdInfo":{"id":"RPN 00-03-21-02"},"secondaryIdInfos":[{"id":"R01DE013906","type":"NIH","link":"https://reporter.nih.gov/quickSearch/R01DE013906"}],"organization":{"fullName":"Johns Hopkins University","class":"OTHER"},"briefTitle":"Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)","officialTitle":"Pain Management in Temporomandibular Joint Disorders"},"statusModule":{"statusVerifiedDate":"2017-07","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2002-11"},"primaryCompletionDateStruct":{"date":"2008-06","type":"ACTUAL"},"completionDateStruct":{"date":"2008-07","type":"ACTUAL"},"studyFirstSubmitDate":"2003-08-07","studyFirstSubmitQcDate":"2003-08-07","studyFirstPostDateStruct":{"date":"2003-08-08","type":"ESTIMATED"},"resultsFirstSubmitDate":"2017-04-17","resultsFirstSubmitQcDate":"2017-07-21","resultsFirstPostDateStruct":{"date":"2017-07-24","type":"ACTUAL"},"lastUpdateSubmitDate":"2017-07-21","lastUpdatePostDateStruct":{"date":"2017-07-24","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Johns Hopkins University","class":"OTHER"},"collaborators":[{"name":"National Institute of Dental and Craniofacial Research (NIDCR)","class":"NIH"}]},"oversightModule":{"oversightHasDmc":true,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false,"isUsExport":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether the combination of cognitive-behavioral treatment and nortriptyline are more effective than each treatment alone in reducing the pain and disability associated with TMD.","detailedDescription":"This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education) treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18 to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week baseline monitoring phase prior to randomization. Active treatment consists of weekly visits for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical and psychosocial function and are assessed at post-treatment, 3-months, and 6-months"},"conditionsModule":{"conditions":["Temporomandibular Joint Disorders"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"FACTORIAL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":140,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Nortriptyline Oral Capsule/CBT","type":"EXPERIMENTAL","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.","interventionNames":["Drug: Nortriptyline Oral Capsule","Behavioral: CBT"]},{"label":"Benztropine Oral Product/CBT","type":"EXPERIMENTAL","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.","interventionNames":["Drug: Benztropine Oral Product","Behavioral: CBT"]},{"label":"Nortriptyline Oral Capsule/Disease MGT","type":"EXPERIMENTAL","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.","interventionNames":["Drug: Nortriptyline Oral Capsule","Behavioral: Disease MGT"]},{"label":"Benztropine Oral Product/Disease MGT","type":"ACTIVE_COMPARATOR","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.","interventionNames":["Drug: Benztropine Oral Product","Behavioral: Disease MGT"]}],"interventions":[{"type":"DRUG","name":"Nortriptyline Oral Capsule","description":"Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.","armGroupLabels":["Nortriptyline Oral Capsule/CBT","Nortriptyline Oral Capsule/Disease MGT"]},{"type":"DRUG","name":"Benztropine Oral Product","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.","armGroupLabels":["Benztropine Oral Product/CBT","Benztropine Oral Product/Disease MGT"]},{"type":"BEHAVIORAL","name":"CBT","description":"Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.","armGroupLabels":["Benztropine Oral Product/CBT","Nortriptyline Oral Capsule/CBT"]},{"type":"BEHAVIORAL","name":"Disease MGT","description":"Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.","armGroupLabels":["Benztropine Oral Product/Disease MGT","Nortriptyline Oral Capsule/Disease MGT"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Average Pain","description":"0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain","timeFrame":"baseline, post-treatment, 3 months, 6 months"},{"measure":"Change in Pain-related Interference","description":"Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference","timeFrame":"baseline, post-treatment, 3 months, 6 months"}],"secondaryOutcomes":[{"measure":"Worst Pain","description":"0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week","timeFrame":"baseline, post-treatment, 3 months, 6 months"},{"measure":"Mental Health as Assessed by the Short Form 36 Healthy Survey","description":"The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).","timeFrame":"baseline, post-treatment, 3 months, 6 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion:\n\n* Age \\>= 18 and \\<= 65\n* Pain \\>= 3 months duration due to temporomandibular joint disorder\n* Pain due to TMD is primary if other pain conditions present\n\nExclusion:\n\n* Continuous, chronic painful non-reducing disc displacement of TMJ and patient can't open mouth\n* Unstable or acute severe pain from another pain condition\n* Patient is pregnant\n* Presence of a medical condition that contraindicates nortriptyline: angle-closure glaucoma,symptomatic orthosis\n* EKG: first degree heart block or QTc \\> 450 msec\n* Unstable angina or a history of a myocardial infarction within the past 3 months\n* Current treatment with an antidepressant which cannot be withdrawn\n* Current use of a medication that interacts with nortriptyline to raise blood levels, such as selective serotonin reuptake inhibitors (e.g.,paroxetine), systemic anti-fungal agents (fluconazole), antiarrhythmics (e.g., quinidine), antipsychotics (e.g., haloperidol), and antibiotics (e.g., erythromycin).\n* Presence of dementia, psychosis or other disorder of cognition that impairs ability to participate in minimal contact intervention\n* Beck Depression Inventory (BDI) score \\>= 35 OR BDI Item #9 (suicide item) is scored \\> 1\n* Patient has a terminal illness with a life expectancy of less than six months\n* History of arthrotomy of temporomandibular joint\n* History of allergic reaction to nortriptyline or benztropine\n* History of a therapeutic trial with nortriptyline (dose \\>= 100 mg for at least 3 weeks)","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"65 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jennifer A Haythornthwaite, Ph.D","affiliation":"Johns Hopkins University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Maryland, Dental School","city":"Baltimore","state":"Maryland","zip":"21201","country":"United States","geoPoint":{"lat":39.29038,"lon":-76.61219}}]},"ipdSharingStatementModule":{"ipdSharing":"NO"}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"FG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"FG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"FG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."}],"periods":[{"title":"Treatment Phase","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"38"},{"groupId":"FG002","numSubjects":"37"},{"groupId":"FG003","numSubjects":"24"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"19"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"11"},{"groupId":"FG003","numSubjects":"5"}]}]},{"title":"3 Month Follow-up","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"38"},{"groupId":"FG001","numSubjects":"33"},{"groupId":"FG002","numSubjects":"26"},{"groupId":"FG003","numSubjects":"19"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"1"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"4"}]}]},{"title":"6 Month Follow-up","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"33"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"25"},{"groupId":"FG003","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"26"},{"groupId":"FG001","numSubjects":"29"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"14"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"3"},{"groupId":"FG003","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"BG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"BG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"BG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."},{"id":"BG004","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"24"},{"groupId":"BG004","value":"140"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"35.7","spread":"12.0"},{"groupId":"BG001","value":"38.4","spread":"12.5"},{"groupId":"BG002","value":"37.2","spread":"11.5"},{"groupId":"BG003","value":"33.3","spread":"11.3"},{"groupId":"BG004","value":"36.4","spread":"11.9"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"28"},{"groupId":"BG003","value":"17"},{"groupId":"BG004","value":"105"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"9"},{"groupId":"BG003","value":"7"},{"groupId":"BG004","value":"35"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"41"},{"groupId":"BG001","value":"38"},{"groupId":"BG002","value":"37"},{"groupId":"BG003","value":"24"},{"groupId":"BG004","value":"140"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Average Pain","description":"0 (no pain) to 10 (pain as bad as could be) rating of average pain during the past week; higher scores indicate greater pain","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline, post-treatment, 3 months, 6 months","groups":[{"id":"OG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"OG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"OG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"OG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"19"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"4.7","spread":"2.2"},{"groupId":"OG001","value":"4.4","spread":"2.1"},{"groupId":"OG002","value":"4.5","spread":"2.2"},{"groupId":"OG003","value":"5.0","spread":"1.8"}]}]},{"title":"post treatment","categories":[{"measurements":[{"groupId":"OG000","value":"2.8","spread":"2.6"},{"groupId":"OG001","value":"2.7","spread":"2.1"},{"groupId":"OG002","value":"2.0","spread":"1.4"},{"groupId":"OG003","value":"2.8","spread":"2.1"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"2.1","spread":"1.6"},{"groupId":"OG001","value":"2.4","spread":"2.2"},{"groupId":"OG002","value":"2.2","spread":"2.1"},{"groupId":"OG003","value":"2.5","spread":"2.1"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"2.0","spread":"1.7"},{"groupId":"OG001","value":"2.0","spread":"2.1"},{"groupId":"OG002","value":"1.4","spread":"1.6"},{"groupId":"OG003","value":"2.2","spread":"2.5"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"OTHER","pValue":"<.05","statisticalMethod":"ANOVA","statisticalComment":"Repeated measures ANOVAs compared baseline to each timepoint"}]},{"type":"PRIMARY","title":"Change in Pain-related Interference","description":"Multidimensional Pain Inventory: Pain interference subscale score; average score computed from 12 items rated on scale from 0=no interference to 6=extreme interference; higher scores indicate greater pain-related interference","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Change in scores on a scale","timeFrame":"baseline, post-treatment, 3 months, 6 months","groups":[{"id":"OG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"OG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"OG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"OG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"19"}]}],"classes":[{"title":"Change in score from baseline to post-treatment","categories":[{"measurements":[{"groupId":"OG000","value":"0.9","spread":"0.9"},{"groupId":"OG001","value":"0.5","spread":"0.9"},{"groupId":"OG002","value":"0.5","spread":"0.7"},{"groupId":"OG003","value":"1.0","spread":"0.9"}]}]},{"title":"Change in score from baseline to 3 months","categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"0.9"},{"groupId":"OG001","value":"0.8","spread":"0.9"},{"groupId":"OG002","value":"1.0","spread":"0.9"},{"groupId":"OG003","value":"1.1","spread":"1.2"}]}]},{"title":"Change in score from baseline to 6 months","categories":[{"measurements":[{"groupId":"OG000","value":"0.8","spread":"0.8"},{"groupId":"OG001","value":"0.7","spread":"1.2"},{"groupId":"OG002","value":"0.7","spread":"0.8"},{"groupId":"OG003","value":"0.8","spread":"1.1"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"OTHER","pValue":"<.05","statisticalMethod":"ANOVA","statisticalComment":"Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)"}]},{"type":"SECONDARY","title":"Worst Pain","description":"0 (no pain) to 10 (pain as bad as could be) rating of worst pain during the past week","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline, post-treatment, 3 months, 6 months","groups":[{"id":"OG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"OG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"OG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"OG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"19"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"6.7","spread":"2.3"},{"groupId":"OG001","value":"6.1","spread":"2.2"},{"groupId":"OG002","value":"6.3","spread":"2.4"},{"groupId":"OG003","value":"7.2","spread":"1.9"}]}]},{"title":"post-treatment","categories":[{"measurements":[{"groupId":"OG000","value":"4.0","spread":"2.9"},{"groupId":"OG001","value":"4.1","spread":"2.8"},{"groupId":"OG002","value":"3.2","spread":"2.1"},{"groupId":"OG003","value":"4.4","spread":"2.6"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"3.6","spread":"2.4"},{"groupId":"OG001","value":"3.3","spread":"2.3"},{"groupId":"OG002","value":"3.4","spread":"2.7"},{"groupId":"OG003","value":"4.1","spread":"2.9"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"3.3","spread":"2.1"},{"groupId":"OG001","value":"3.1","spread":"2.7"},{"groupId":"OG002","value":"2.7","spread":"2.2"},{"groupId":"OG003","value":"3.4","spread":"2.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"OTHER","pValue":"<.05","statisticalMethod":"ANOVA","statisticalComment":"Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)"}]},{"type":"SECONDARY","title":"Mental Health as Assessed by the Short Form 36 Healthy Survey","description":"The Mental Health Component score from the Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health. The mental health component score is calculated from responses to the general health, mental health, vitality, physical and emotional role limitations, and social functioning subscales, with higher scores indicating better mental health. The scale ranges from zero (equivalent to maximum disability) to 100 (no disability).","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units on a scale","timeFrame":"baseline, post-treatment, 3 months, 6 months","groups":[{"id":"OG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT."},{"id":"OG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT."},{"id":"OG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management."},{"id":"OG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"38"},{"groupId":"OG001","value":"33"},{"groupId":"OG002","value":"26"},{"groupId":"OG003","value":"19"}]}],"classes":[{"title":"baseline","categories":[{"measurements":[{"groupId":"OG000","value":"50.5","spread":"8.1"},{"groupId":"OG001","value":"49.2","spread":"9.3"},{"groupId":"OG002","value":"51.2","spread":"8.8"},{"groupId":"OG003","value":"48.0","spread":"8.9"}]}]},{"title":"post-treatment","categories":[{"measurements":[{"groupId":"OG000","value":"50.8","spread":"10.4"},{"groupId":"OG001","value":"48.4","spread":"8.1"},{"groupId":"OG002","value":"52.6","spread":"10.0"},{"groupId":"OG003","value":"53.3","spread":"10.6"}]}]},{"title":"3 months","categories":[{"measurements":[{"groupId":"OG000","value":"51.5","spread":"8.9"},{"groupId":"OG001","value":"50.2","spread":"8.7"},{"groupId":"OG002","value":"52.6","spread":"10.0"},{"groupId":"OG003","value":"53.8","spread":"10.1"}]}]},{"title":"6 months","categories":[{"measurements":[{"groupId":"OG000","value":"52.2","spread":"7.8"},{"groupId":"OG001","value":"53.3","spread":"12.8"},{"groupId":"OG002","value":"52.3","spread":"7.2"},{"groupId":"OG003","value":"53.6","spread":"7.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003"],"nonInferiorityType":"OTHER","pValue":"<.05","statisticalMethod":"ANOVA","statisticalComment":"Repeated measures ANOVAs compared baseline scores to each period of follow-up (post-treatment, 3-months, 6 months)"}]}]},"adverseEventsModule":{"frequencyThreshold":"4","timeFrame":"Adverse event data were collected weekly during the treatment phase, then at 3- and 6-months","eventGroups":[{"id":"EG000","title":"Nortriptyline Oral Capsule/CBT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of CBT.","deathsNumAffected":0,"deathsNumAtRisk":41,"seriousNumAffected":0,"seriousNumAtRisk":41,"otherNumAffected":32,"otherNumAtRisk":41},{"id":"EG001","title":"Benztropine Oral Product/CBT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of CBT.","deathsNumAffected":0,"deathsNumAtRisk":38,"seriousNumAffected":0,"seriousNumAtRisk":38,"otherNumAffected":24,"otherNumAtRisk":38},{"id":"EG002","title":"Nortriptyline Oral Capsule/Disease MGT","description":"Nortriptyline taken at bedtime titrated to a dose up to 150 mg. Study participants also receive 6 sessions of TMD disease management.","deathsNumAffected":0,"deathsNumAtRisk":37,"seriousNumAffected":0,"seriousNumAtRisk":37,"otherNumAffected":21,"otherNumAtRisk":37},{"id":"EG003","title":"Benztropine Oral Product/Disease MGT","description":"Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile. Study participants also receive 6 sessions of TMD disease management.","deathsNumAffected":0,"deathsNumAtRisk":24,"seriousNumAffected":0,"seriousNumAtRisk":24,"otherNumAffected":15,"otherNumAtRisk":24}],"otherEvents":[{"term":"drymouth","organSystem":"General disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":41},{"groupId":"EG001","numAffected":14,"numAtRisk":38},{"groupId":"EG002","numAffected":13,"numAtRisk":37},{"groupId":"EG003","numAffected":9,"numAtRisk":24}]},{"term":"sedation","organSystem":"Nervous system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":41},{"groupId":"EG001","numAffected":8,"numAtRisk":38},{"groupId":"EG002","numAffected":7,"numAtRisk":37},{"groupId":"EG003","numAffected":3,"numAtRisk":24}]},{"term":"constipation","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":41},{"groupId":"EG001","numAffected":7,"numAtRisk":38},{"groupId":"EG002","numAffected":9,"numAtRisk":37},{"groupId":"EG003","numAffected":4,"numAtRisk":24}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Jennifer Haythornthwaite","organization":"Johns Hopkins University","email":"jhaytho1@jhmi.edu","phone":"410-550-7985"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"conditionBrowseModule":{"meshes":[{"id":"D013705","term":"Temporomandibular Joint Disorders"}],"ancestors":[{"id":"D017271","term":"Craniomandibular Disorders"},{"id":"D008336","term":"Mandibular Diseases"},{"id":"D007571","term":"Jaw Diseases"},{"id":"D009140","term":"Musculoskeletal Diseases"},{"id":"D007592","term":"Joint Diseases"},{"id":"D009135","term":"Muscular Diseases"},{"id":"D009057","term":"Stomatognathic Diseases"}]},"interventionBrowseModule":{"meshes":[{"id":"D009661","term":"Nortriptyline"}],"ancestors":[{"id":"D003986","term":"Dibenzocycloheptenes"},{"id":"D001567","term":"Benzocycloheptenes"},{"id":"D011084","term":"Polycyclic Aromatic Hydrocarbons"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D011083","term":"Polycyclic Compounds"}]}},"hasResults":true}