Individualized Assessment and Treatment for TMD (TMD3c)

August 19, 2026 updated by: Mark Litt, UConn Health

Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Temporomandibular/orofacial pain disorders (TMD) are a group of painful conditions with multiple determinants. A number of psychosocial treatments for TMD have been developed, but overall effectiveness has been limited, and the mechanisms of treatment are unknown. 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. Patients with TMD-related pain of at least 3 months duration (N=160) will be randomly assigned to either a Standard Conservative Treatment +Cognitive Behavioral coping skills treatment (STD+CBT), or to an Individualized Assessment and cognitive-behavioral Treatment Program (IATP) for patients with TMD pain. Treatment in IATP will be based on a very detailed functional analysis of the patient's pain experience, in context, as derived from Experience Sampling (ES). The ES procedure will be conducted via smartphone app at a rate of 4 records per day, and will be used to gather information on patients' pain, momentary cognitions, affects, and coping behaviors, for a 2-week monitoring period prior to the beginning of treatment. Therapists will use this information to develop an individual functional analysis of pain and non-pain episodes, and determine what thoughts, feelings and actions are effective for that patient at managing pain and which are not. The information will be used to help develop adaptive coping tactics in a 6-session treatment program, offering skills training tailored to specific patient needs. During-treatment ES will allow adjustment of the treatment goals and procedures, making the treatment adaptive and able to change with changing circumstances and patient needs. This experimental treatment (IATP) will be added to a standard conservative splint-based treatment for TMD pain (STD). The combination (STD+IATP) will be compared to a STD treatment supplemented with a 6 session conventional cognitive-behavioral program not based on in-vivo assessment of pain and coping. In the STD+CBT condition ES data will be collected but will not be used to inform treatment, but will control for measurement reactivity. ES data collected prior to, during, and following both treatments (out to 12 months) will allow very precise measurement of cognitions, affects, and coping skills, as they occur in patients' home environments, and how they change over time. Outcomes will include measures of pain, interference, and depressive symptoms. 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. The study will be able to tailor treatment based on patient experiences measured in near-real time at pain episodes, allow for adaptation of treatment as it progresses, and measure the impact on outcomes of coping changes over the long-term. The results will shed light on active mechanisms of treatment for TMD and may have implications for the management of other chronic pain conditions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Mark D Litt, PhD
  • Phone Number: 860-679-4680
  • Email: Litt@uchc.edu

Study Contact Backup

  • Name: Elise Kabela-Cormier, PhD
  • Phone Number: 8606792657
  • Email: kabela@uchc.edu

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • UConn Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age > 18 years
  2. Jaw pain > 3 mo; > 3/10 on pain scale
  3. Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement

  4. Positive on > 1 of:

    1. Any myalgia diagnosis
    2. Any myofascial diagnosis
    3. Arthralgia
    4. TMD-related Headache

Exclusion Criteria:

  1. Lack of fluency in English
  2. Previous invasive surgery for TMD, not including arthrography or arthrocentesis
  3. Extensive anatomical destruction or deterioration of the TM joint
  4. Diagnosed as having pain of neuropathic or odontogenic origin
  5. Carrying a diagnosis of psychosis
  6. Taking narcotic pain medication
  7. Any comorbid condition necessitating use of an intraoral appliance (e.g., obstructive sleep apnea)
  8. Pregnancy (excluded due to prescription of NSAIDs)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: STD+CBT
Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment
Behavioral: Cognitive-Behavioral Treatment
Cognitive-behavioral coping skills training
Other Names:
  • CBT
Other: Standard Conservative Care
Standard conservative dental care for orofacial pain
Other Names:
  • STD
Experimental: STD+IATP
Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure.
Other: Standard Conservative Care
Standard conservative dental care for orofacial pain
Other Names:
  • STD
Behavioral: Individualized Assessment and Treatment Program
Experience-sampling based cognitive behavioral coping skills assessment and training
Other Names:
  • IATP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Characteristic Pain Intensity will be calculated by averaging the ratings of current pain, average pain, and worst pain in the past week from the Graded Chronic Pain Scale (GCPS; Von Korff et al., 1992). Each item is scored from 0 -10.
Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Change in interference with activities from Baseline as measured at all follow-up points by the 10-item Interference scale from the Multidimensional Pain Inventory (MPI; Kerns, Turk, & Rudy, 1985).
Time Frame: Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
The MPI is a widely used, validated self-report inventory assessing various areas of impact by chronic pain. The Interference scale iconsists of 10 itmes assessing various areas of life that may have been affected or changed by chronic pain. Each item is scored from 0 to 6 (No change to Extreme Change).
Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Change in Depressive Symptoms from baseline as measured by the 20-item Center for Epidemiological Studies Depression scale Revised (CESD-R) 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
CESD-R is a 20-item scale assessing depressive symptoms. It was developed by the Center for Epidemiologic Studies (Radlof, 1977), and has shown high reliability and validity. The 20 items describe behaviors or feelings characteristic of depression that people may have. Respondents are instructed to indicate the extent they experience each item on a scale from Rarely to Most of the Time. The total score ranges from 0 to 80, with higher scores indicting mroe severe depressive symptomatology.
Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain coping ability from baseline will be measured at each follow-up point using the Brief Pain Coping Inventory (BCPI; McCracken et al., 2005).
Time Frame: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
The Brief Pain Coping Inventory is a well-validated scale to assess the use of coping strategist to manage chronic pain. The scale consists of 29 strategies and asks respondents to indicate on how many days of the past 7 each of those strategies was used. The total score from 0 - 203 indicates the total coping ability, with higher scores indicating greater use of coping strategies.
Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Change in pain self-efficacy from baseline as measured using the Facial Pain Self-Efficacy Scale (Brister, Turner, Aaron, & Mancl, 2006) 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
The Facial Pain Self-Efficacy scale consists of 8 items asking the respondent to indicate on a scale from 0 (very uncertain) to 10 (very certain) the extent to which he or she is confident about being able to manage various aspects of chronic pain, including emotional effects, and physical limitations. The total score from 0-80 is calculated by summing the total of all the items. The scale has shown to be reliable and valid.
Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Change in pain catastrophizing from baseline using the Pain Catastrophizing Scale (PCS; Sullivan et al., 1995) 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
The Pain Catastrophizing Scale is a well-validated measure of pain catastrophizing. The scale consists of 13 items scored from 0 to 4 that asks the respondent to indicate how often he or she has thoughts about pain that reflect exaggeration of the impact and loss of control of chronic pain. The scale is widely used and well-validated.
Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant rating of improvement as measured at each follow-up by the Patient Global Impression of Change scale (PGIC; Hurst & Bolton, 2004).
Time Frame: Follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
The PGIC consists of two questions in two different formats asking for a global assessment of "change if any, in activity limitations, symptoms, emotions and overall quality of life." A 2-point change on the rating scale has been calculated to be clinically significant.
Follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UConn Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark D Litt, PhD, UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-045-2
  • U01DE028520 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be made available to other researchers upon request to the Principal Investigator once all data collection is completed and the primary article related to this study is published.

IPD Sharing Time Frame

Data will be available once all data collection is completed and the primary article related to this study is published. Data will remain available until further notice.

IPD Sharing Access Criteria

Requestors must be credentialed investigators, with active institutional affiliation, or students in active degree programs

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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