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NCT01794624 · ClinicalTrials.gov registry record · NA
Biobehavioral Pain Management in TMD
A NA study of Temporomandibular Joint Disorder, sponsored by Johns Hopkins University.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT01794624 is a NA study of Temporomandibular Joint Disorder that has completed, run by Johns Hopkins University. The registered enrollment target is 300 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT01794624, a NA study of Temporomandibular Joint Disorder, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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 ed
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Therapy for Catastrophizing
- BEHAVIORAL Behavioral Therapy for Sleep Continuity Disturbance
Study Locations (2)
Maryland
- University of Maryland Dental School: Brotman Facial Pain Clinic - Baltimore
- Johns Hopkins Bayview Meidical Center: Behavioral Medicine Research Laboratory - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-04 |
| Est. Completion | 2018-06 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01794624
The ClinicalTrials.gov registry entry for NCT01794624 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Temporomandibular Joint Disorder appearing as the primary indexed condition, and to 2 interventions - of which Cognitive Therapy for Catastrophizing is the first listed.
NCT01794624 reports 2 study locations spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01794624 about?
NCT01794624 is a clinical study titled "Biobehavioral Pain Management in TMD". 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) a...
What is the current status of trial NCT01794624?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2013-04. Estimated completion is 2018-06.
What conditions does trial NCT01794624 study?
This clinical trial studies the following conditions: Temporomandibular Joint Disorder.
What interventions are being tested in trial NCT01794624?
The interventions under investigation include: Cognitive Therapy for Catastrophizing (BEHAVIORAL), Behavioral Therapy for Sleep Continuity Disturbance (BEHAVIORAL).
Who is sponsoring clinical trial NCT01794624?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01794624 being conducted?
This trial has 2 study locations across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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