Individualized Assessment and Treatment for TMD

Part of paid clinical trials in Farmington, Connecticut.

Sponsor
UConn Health
Study ID
NCT04376333
Status
Recruiting
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Conditions

  • Orofacial Pain
  • Temporomandibular Joint Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cognitive-Behavioral Treatment — BEHAVIORAL
    Cognitive-behavioral coping skills training
  • Individualized Assessment and Treatment Program — BEHAVIORAL
    Experience-sampling based cognitive behavioral coping skills assessment and training
  • Standard Conservative Care — OTHER
    Standard conservative dental care for orofacial pain

Study Details

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants.This proposal has two main goals: 1) to test a highly individualized, adaptive treatment for TMD that has potential to be more effective than other psychosocial treatments; and 2) to discover the mechanisms by which psychosocial treatments work in chronic pain. TMD patients (N=160) will be randomized to receive standard care (STD) + an individualized assessment and treatment program (IATP) or to standard care + conventional cognitive-behavioral treatment (STD+CBT). It is expected that the STD+IATP treatment will yield lower pain, depression and interference scores over time than STD+CBT, and that changes in coping ability will mediate the treatment effects on outcomes.

Key Dates

First listed
May 6, 2020
Start date
Feb 3, 2021
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: STD+CBT
    Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment
  • Experimental: STD+IATP
    Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure.

Primary Outcome Measure

Change in pain from baseline as measured by the 11-point Characteristic Pain Intensity Index at each follow-up point [ Time Frame: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UConn HealthFarmingtonConnecticut06030
Elise Kabela, PhD
[email protected]
860-679-2745
Kara Dion, BA
[email protected]
860-679-4767
Mark D Litt, Ph.D. (PRINCIPAL_INVESTIGATOR)

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