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| ID | Type | Description | Link |
|---|---|---|---|
| 3U01DE028520-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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; i.e., 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| painTRAINER pain management web application | Experimental | This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| painTRAINER | Behavioral | patient self-administered pain management web application |
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment Feasibility | Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program. This number of patients recruited over this time period would indicate that the program is attractive to the target patient population. If this number finish the program, it would indicate that the program was a feasible means of intervention. | 8 months |
| The Treatment Credibility/Expectancy Questionnaire | The Treatment Credibility/Expectancy Questionnaire is composed of 4 questions that assess treatment credibility, or the extent to which a treatment seems logical and able to address patient complaints. The credibility scores may range from 4 to 36, with higher scores indicating greater endorsement of credibility. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Pain: Change in Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) Score | Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score: GCPS-CPI is made up of 3 questions asking the patient to rate their pain Now, at its worst, and on average over the past 30 days. Scores on the index may range from 0 to 30, with higher scores indicative of greater characteristic pain. Outcome is measured in change from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Litt, PhD | UConn Heatlh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06030 | United States |
Summary data will be made available to interested investigators by the PI
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21 persons with TMD/orofacial pain of at least 3mo duration were recruited through advertisements and referrals from local dentists
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| ID | Title | Description |
|---|---|---|
| FG000 | painTRAINER Pain Management Web Application | This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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We recruited 1 person more than initially planned in order to make up for losses to follow-up
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| ID | Title | Description |
|---|---|---|
| BG000 | painTRAINER Pain Management Web Application | This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Feasibility | Treatment is deemed feasible if 20 persons are recruited with 8 months and complete the program. This number of patients recruited over this time period would indicate that the program is attractive to the target patient population. If this number finish the program, it would indicate that the program was a feasible means of intervention. | 21 persons were recruited, supporting treatment feasibility | Posted | Count of Participants | Participants | 8 months |
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Up to 12 weeks from baseline
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | painTRAINER Pain Management Web Application | This is a patient-administered pain management training program delivered in 10 sessions over 8 weeks. Each session is composed of different skills useful for managing chronic pain. Each session is also accompanied by recommendations for skills practice to be done between sessions. painTRAINER: patient self-administered pain management web application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark D. Litt, PhD | UConn Health | 860-679-4680 | Litt@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2023 | Oct 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 29, 2023 | Oct 16, 2024 | ICF_001.pdf |
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Feasibility study
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| baseline to 3 months after treatment |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Demographics: Race | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Graded Chronic Pain Scale | The Graded Chronic Pain Scale is a multidimensional measure that assesses 2 dimensions of overall chronic pain severity: pain intensity and pain-related disability. In the current study 3 items were averaged to produce a reliable pain index as an outcome measure: current pain, average pain, and worst pain in the past week | Mean | Standard Deviation | units on a scale |
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| Primary | The Treatment Credibility/Expectancy Questionnaire | The Treatment Credibility/Expectancy Questionnaire is composed of 4 questions that assess treatment credibility, or the extent to which a treatment seems logical and able to address patient complaints. The credibility scores may range from 4 to 36, with higher scores indicating greater endorsement of credibility. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | Patient Pain: Change in Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) Score | Graded Chronic Pain Scale Characteristic Pain Intensity (GCPS-CPI) score: GCPS-CPI is made up of 3 questions asking the patient to rate their pain Now, at its worst, and on average over the past 30 days. Scores on the index may range from 0 to 30, with higher scores indicative of greater characteristic pain. Outcome is measured in change from baseline. | Posted | Mean | Standard Deviation | score on a scale: decrease in pain score | baseline to 3 months after treatment |
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| 18 |
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| 18 |
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| 18 |
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