Biobehavioral Pain Management in TMD
NCT01794624 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2018-07-19
Summary
TMD is a poorly understood chronic pain disorder that affects up to 15% of the adult population, notably impacting women, is linked to greater healthcare utilization, and associated with multiple pain-related co-morbidities. Pain-related catastrophizing (CAT) and sleep continuity disturbance (SCD) are well established modifiable risk factors for TMD and other idiopathic pain conditions. Neither the causal status nor the neurobiological mechanisms by which these factors exert their effects on clinical pain have been established. We propose that CAT and SCD influence clinical pain through shared alterations in pain modulation and key neurobiological pathways, including amplified inflammatory activity, autonomic activity, and adrenocortical functioning. Beyond these shared mechanisms, however, we propose to determine whether pre-sleep CAT increases cortical arousal during sleep. The cognitive dimensions of pre-sleep arousal, particularly rumination and negative sleep-related thoughts, are central to the phenomenology of insomnia. Extending this notion, we propose that CAT in those experiencing ongoing clinical pain fosters sleep disturbance owing to increased pre- and peri-sleep cognitive arousal. Moreover, we propose that pre-sleep CAT is related to subtle variations in objective indices of fragmented sleep (e.g., cortical arousal). We will examine key hypotheses derived from this framework using a brief, prospective randomized experiment, which will permit careful analysis of the temporal patterning of how changes in either CAT or SCD influence each other and contribute to alterations in pain modulatory systems, key nociceptive mechanisms, and clinical pain.
Women experiencing at least moderate chronic TMD pain (N=225) who demonstrate at least mild trait catastrophizing and meet at least subclinical insomnia criteria (SCD) will be randomly assigned to: 1) cognitive therapy for catastrophizing (CT-CAT); 2) behavior therapy for sleep disturbance (BT-SCD); or 3) TMD education (Control). Assessments of clinical pain, sleep disturbance, catastrophizing, pain sensitivity and modulatory systems, and indices of inflammatory activity, adrenocortical function and autonomic balance will be completed at baseline, 4 weeks (mid-manipulation) and 8 weeks (post-manipulation). Clinical pain, sleep, catastrophizing and covariates will additionally be measured at 16 weeks (follow-up).
Conditions
- Temporomandibular Joint Disorder
Interventions
- BEHAVIORAL
-
Cognitive Therapy for Catastrophizing
Cognitive Therapy for Catastrophizing will involve a standardized, 6-session cognitive intervention, focusing on cognitive restructuring techniques for managing pain and reducing catastrophic thinking and includes some general coping skills training. Cognitive restructuring includes identifying patterns of dysfunctional thinking which can give rise to emotional distress, physiological arousal, or maladaptive behaviors. Patients are taught to identify and replace distorted thinking with balanced, realistic thinking. Patients learn to identify these thoughts as they occur in daily life and challenge their own negative thoughts.
- BEHAVIORAL
-
Behavioral Therapy for Sleep Continuity Disturbance
Behavioral Therapy for Sleep Continuity Disturbance (BT-SCD) will involve 6-sessions of standardized interventions on sleep restriction therapy (SRT), stimulus control therapy (SCT), and sleep hygiene education. Sleep Restriction curtails the amount of time in bed so that it matches the average baseline amount of total sleep time. Stimulus Control Therapy re-establishes the bed and bedroom as cues for sleep by insuring the patient does not spend significant time in bed awake and/or engaging in sleep-incompatible behaviors. Sleep Hygiene Education uses motivational interviewing to teach subjects about environmental and behavioral factors which may influence sleep. SRT and SCT alone or combined have demonstrated overwhelming efficacy and effectiveness.
Sponsors & Collaborators
-
National Institute of Dental and Craniofacial Research (NIDCR)
collaborator NIH -
University of Maryland
collaborator OTHER - lead OTHER
Principal Investigators
-
Jennifer A Haythornthwaite · Johns Hopkins University
-
Michael T Smith · Johns Hopkins University
-
Jaime Brahim · University of Maryland, School of Dentistry
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-04-30
- Primary Completion
- 2018-04-30
- Completion
- 2018-06-30
Countries
- United States
Study Locations
More Related Trials
-
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD Recovery
NCT05935735 ·Status: COMPLETED ·Phase: NA
-
Dual Treatment of Chronic Pain and Insomnia
NCT05033418 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavior Therapy for Insomnia (CBT-I) in Persons With Traumatic Brain Injury (TBI)
NCT02709980 ·Status: COMPLETED ·Phase: NA
-
Internet Administered CBT for Insomnia Comorbid With Chronic Pain
NCT03425942 ·Status: COMPLETED ·Phase: NA
-
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
NCT06441864 ·Status: RECRUITING ·Phase: NA
-
Implementation of Brief Insomnia Treatments - Clinical Trial
NCT02724800 ·Status: COMPLETED ·Phase: NA
-
Digital CBT-I for Patients With Chronic Pain and Insomnia
NCT06361914 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Behavioral Treatments for Chronic Pain
NCT00371865 ·Status: COMPLETED ·Phase: NA
-
Development of an Insomnia Treatment for Depressed Adolescents
NCT02163564 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavioral Therapy for Insomnia in Chronic Pain Patients
NCT00133601 ·Status: COMPLETED ·Phase: PHASE1
-
Cognitive Behavioral Therapy for Insomnia with RTMS
NCT04258618 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad
NCT04426838 ·Status: COMPLETED ·Phase: NA
-
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
NCT03261674 ·Status: COMPLETED ·Phase: NA
-
Intervention for Sleep and Pain in Youth
NCT03137147 ·Status: COMPLETED ·Phase: NA
-
Internet-based Cognitive Behavioral Therapy for Tinnitus Sufferers
NCT04335812 ·Status: COMPLETED ·Phase: NA
-
NiteCAPP_HELPS_WD: Improving Sleep and Reducing Opioid Use in Chronic Pain Patients
NCT05226026 ·Status: WITHDRAWN ·Phase: NA
-
CBT-based Internet Intervention for Adults With Tinnitus in the United States
NCT04004260 ·Status: COMPLETED ·Phase: NA
-
Behavioral Intervention for Insomnia in Older Adults
NCT01154023 ·Status: COMPLETED ·Phase: NA
-
Cognitive Behavioral Therapy for Insomnia in Substance Use Disorders
NCT03208855 ·Status: COMPLETED ·Phase: NA
-
Behavioral Insomnia Therapy With Chronic Fatigue Syndrome
NCT00540254 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Effects of Nurse-Guided BBTi for Improving Insomnia : in Patients at the Recovery Following Traumatic Brain Injury
NCT05402761 ·Status: RECRUITING ·Phase: NA
-
A Comparison of the Benefits of Mindfulness Based Cognitive Therapy, Relaxation Therapy and a Waiting List Control in the Management of Distress in Chronic Tinnitus Patients
NCT02059447 ·Status: COMPLETED ·Phase: NA
-
Social & Behavioral Rhythms in Chronic Pain
NCT03022643 ·Status: COMPLETED ·Phase: NA
-
Behavioral Insomnia Treatment in Mild Traumatic Brain Injury
NCT06551987 ·Status: RECRUITING ·Phase: NA
-
Neurofeedback for Borderline Personality Disorder
NCT05398627 ·Status: COMPLETED ·Phase: NA