Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04376333
Status:
RECRUITING
Last Update Posted:
2023-06-07
First Post:
2020-05-01
Brief Title:
Individualized Assessment and Treatment for TMD
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Individualized Assessment and Treatment Program for TMD Coping as a Mechanism
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TMD3c
Brief Summary:
Temporomandibularorofacial pain disorders TMD are a group of painful conditions with multiple determinantsThis 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 N160 will be randomized to receive standard care STD an individualized assessment and treatment program IATP or to standard care conventional cognitive-behavioral treatment STDCBT It is expected that the STDIATP treatment will yield lower pain depression and interference scores over time than STDCBT and that changes in coping ability will mediate the treatment effects on outcomes
Detailed Description:
Temporomandibularorofacial 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 N160 will be randomly assigned to either a Standard Conservative Treatment Cognitive Behavioral coping skills treatment STDCBT 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 patients 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 STDIATP 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 STDCBT 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 STDIATP treatment will yield lower pain depression and interference scores over time than STDCBT 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01DE028520 | NIH | None | httpsreporternihgovquickSearchU01DE028520 |