Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862870
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2023-05-08
Brief Title:
TMD Online Program for Pain Management
Sponsor:
UConn Health
Organization:
UConn Health
Study Overview
Official Title:
Mobile Application Treatment for TMD Feasibility Trial
Status:
COMPLETED
Status Verified Date:
2023-12
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:
None
Brief Summary:
This is a proposal for an administrative supplement to the parent study Individualized Assessment and Treatment Program for TMD Coping as a Mechanism U01 DE028520 The parent study is currently engaged in exploring the extent to which the training of coping skills per se is an important mechanism of psychosocial treatment The current project seeks to lay the groundwork for expanding the range of treatment mechanisms examined to include therapeutic relationship factors therapist support empathy acknowledgment The present supplemental study will provide instruction for individual patient pain management via an online application with no therapist or counselor assistance The aim is to determine the extent to which treatment-related outcomes including adherence and pain may be influenced by therapist support factors
Detailed Description:
Psychosocial treatments have been effective for temporomandibular disorders TMD but the mechanisms of action for these treatments are unclear Most studies of psychosocial treatment including the parent U01 have focused on relatively specific psychosocial mechanisms including coping skills acquisition pain management self-efficacy decrease in catastrophizing increased mindfulness acceptance and readiness to change behavior to ameliorate pain The 2 therapist-delivered treatments in the parent study are packaged CBT or Individualized Assessment and Treatment IATP Left untested in this study are common therapeutic factors that often emerge as influential in pain outcome research These common non-specific therapeutic factors include especially the therapeutic alliance interpretation and understanding emotional expression reinforcement information and reassurance and support Because both conditions of the parent U01 involve similar levels of therapist involvement therapist support and other treatment-non-specific variables cannot be tested clearly One way to assess these factors is to introduce a pain treatment that explicitly does not contain these factors ie a treatment that does not employ therapists or require supervision by health care professionals There are currently no studies published in which therapist-led treatments have been compared to a mobile application-based treatment
The Investigators therefore propose to pilot test a mobile application treatment condition painTrainer added as an additional treatment condition to the parent study and provided to 20 patients in the coming year This condition will deliver the content of the CBT condition of the parent study but will do so with no therapist contact If this mobile application is found credible and acceptable it may be used in additional comparisons with treatments conducted by therapists Thus at some point it will be possible to parse the effects of cognitive-behavioral treatment content per se and therapist support factors
An additional benefit of testing such a mobile application is that it might in the future provide a means to expand the reach of pain management professionals to remote and underserved populations
The Investigators therefore propose to pilot test a mobile application treatment condition painTrainer added as an additional treatment condition to the parent study and provided to 20 patients in the coming year This condition will deliver the content of the CBT condition of the parent study but will do so with no therapist contact If this mobile application is found credible and acceptable it may be used in additional comparisons with treatments conducted by therapists Thus at some point it will be possible to parse the effects of cognitive-behavioral treatment content per se and therapist support factors
An additional benefit of testing such a mobile application is that it might in the future provide a means to expand the reach of pain management professionals to remote and underserved populations
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