Temporomandibular Joint DisordersTMD3cNCT04376333
Individualized Assessment and Treatment for TMD
A study testing Cognitive-Behavioral Treatment, Individualized Assessment and Treatment Program and Standard Conservative Care in people with Temporomandibular Joint Disorders and Orofacial Pain, run by UConn Health at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Joint Disorders, Orofacial Pain
- What is being tested?
- Cognitive-Behavioral Treatment, Individualized Assessment and Treatment Program and Standard Conservative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Jaw pain > 3 mo; > 3/10 on pain scale
- Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement
- Positive on > 1 of:
- Any myalgia diagnosis
- Any myofascial diagnosis
- Arthralgia
- TMD-related Headache
Who cannot join
- Lack of fluency in English
- Previous invasive surgery for TMD, not including arthrography or arthrocentesis
- Extensive anatomical destruction or deterioration of the TM joint
- Diagnosed as having pain of neuropathic or odontogenic origin
- Carrying a diagnosis of psychosis
- Taking narcotic pain medication
- Any comorbid condition necessitating use of an intraoral appliance (e.g., obstructive sleep apnea)
- Pregnancy (excluded due to prescription of NSAIDs)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders, Orofacial Pain
- Being tested
- Cognitive-Behavioral Treatment, Individualized Assessment and Treatment Program, Standard Conservative Care
- Keywords
- TMD, orofacial pain, chronic pain, coping, ecological momentary assessment
- Medical subject headings
- Temporomandibular Joint Disorders, Facial Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral TreatmentBehavioural
Also called CBT
Cognitive-behavioral coping skills training
Individualized Assessment and Treatment ProgramBehavioural
Also called IATP
Experience-sampling based cognitive behavioral coping skills assessment and training
Standard Conservative CareOther
Also called STD
Standard conservative dental care for orofacial pain
| Study group | Role | What they receive |
|---|---|---|
| STD+CBT | Active comparator | Standard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment Receives: Behavioral: Cognitive-Behavioral Treatment; Other: Standard Conservative Care |
| STD+IATP | Experimental | Standard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure. Receives: Behavioral: Individualized Assessment and Treatment Program; Other: Standard Conservative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain from baseline as measured by the 11-point Characteristic Pain Intensity Index at each follow-up point
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.
Measured: 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).
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).
Measured: 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
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.
Measured: Baseline and at the follow-up points 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (3)
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).
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.
Measured: 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.
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.
Measured: 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
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.
Measured: Baseline and at the follow-up points: 7 weeks (posttreatment), 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start3 Feb 2021
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-group randomized clinical trail
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Mark Litt, UConn Health
- Investigators
- Mark D Litt, PhD, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376333
- Sponsor's protocol ID
- 20-045-2
- Other IDs
- U01DE028520
- Acronym
- TMD3c
- Status last verified
- Aug 2026
- First submitted
- 1 May 2020
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism
- ClinicalTrials.gov ID
- NCT04376333
- Acronym / sponsor ID
- TMD3c / 20-045-2
- Conditions
- Temporomandibular Joint Disorders, Orofacial Pain
- Keywords
- TMD, orofacial pain, chronic pain, coping, ecological momentary assessment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 6 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-group randomized clinical trail
| Arm | Type | Receives |
|---|---|---|
| STD+CBT | Active comparator | Behavioral: Cognitive-Behavioral Treatment, Other: Standard Conservative CareStandard conservative dental orofacial pain care + cognitive-behavioral coping skills treatment |
| STD+IATP | Experimental | Behavioral: Individualized Assessment and Treatment Program, Other: Standard Conservative CareStandard conservative dental orofacial pain care + Individualized Assessment and Treatment Program; a highly individualized coping skills training procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age > 18 years
- Jaw pain > 3 mo; > 3/10 on pain scale
- Positive Axis I diagnosis on the Diagnostic Criteria for temporomandibular disorders (DC/TMD), with or without disc displacement
- Positive on > 1 of:
Key exclusion criteria (8 listed)
- Lack of fluency in English
- Previous invasive surgery for TMD, not including arthrography or arthrocentesis
- Extensive anatomical destruction or deterioration of the TM joint
- Diagnosed as having pain of neuropathic or odontogenic origin
- Carrying a diagnosis of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral TreatmentAlso: CBTCognitive-behavioral coping skills training | Behavioural | STD+CBT |
| Individualized Assessment and Treatment ProgramAlso: IATPExperience-sampling based cognitive behavioral coping skills assessment and training | Behavioural | STD+IATP |
| Standard Conservative CareAlso: STDStandard conservative dental care for orofacial pain | Other | STD+CBT, STD+IATP |
Primary outcome
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.
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).
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.
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Litt, PhD principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-Behavioral Treatment, Individualized Assessment and Treatment Program and Standard Conservative Care in people with Temporomandibular Joint Disorders and Orofacial Pain, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.