Tailored Self-Management of Temporomandibular Disorders (TMD) Using Health Information Technology

The primary study objectives of the PACT study are two-fold:

1. Evaluate the feasibility of methods to conduct a full-scale multi-site randomized
clinical trial comparing PACT self-management with traditional self-care for TMD. The
study will also evaluate strategies to: identify, recruit, consent, and enroll eligible
subjects into both groups meeting target goal; evaluate adherence to intervention and
identification of barriers; evaluate adherence to outcomes assessment, and evaluate the
on-line web-site functionality and acceptability.

2. To demonstrate ability to accurately capture outcome measures to be used in the
multi-site study.

Primary study objective: Recruitment is measured through achievement of target sample, number
of patients identified that meet eligibility criteria, and number (%) of subjects consenting
compared with total contacted.

Intervention adherence is measured by: number of participants enrolled in both groups, number
of participants accessing on-line materials, completion of practice logs, and identification
of self-reported barriers of participation in self-care. Outcome adherence is measured by the
number of participants who complete the baseline assessment, complete the two and four month
follow-up assessments, complete the program evaluation, and complete qualitative post-study
interview. Website acceptability is measure by identification of problems and barriers during
use and quality and ease of use at the post-intervention evaluation.

Second objective: Efficacy of the program is measured by self-reported outcome assessments.
The primary outcomes include TMD symptoms, jaw functioning, and emotional functioning.
Secondary outcomes measures include symptom severity with the temporal aspects of pain, pain
interference, and patient ratings of improvement. Additional information on mediators and
modifiers will also be gathered to help inform the how and why the intervention has an
effect. Mediators will be measured to identify factors that help explain why PACT may have an
effect including self-efficacy, patient activation, exercise level, sleep quality, and social
support. Contextual process factors to identify in whom the intervention does and does not
work include disability status, catastrophizing, depression, repetitive strain from oral
habits, and perceived stress.

Inclusion Criteria:

- In order to be eligible to participate in this study, an individual must meet all of
the following criteria:

- Age 18 or older

- Able and willing to access the internet on a regular basis

- Able to read and speak English

- Be willing to comply with all study procedures:

1. Randomly assigned to either arm of the study

2. Be available for the duration of the study

3. Complete study data collection forms

4. Reachable by phone and able to participate in weekly phone coaching calls if
randomized to the PACT arm

- Have a diagnosis of TMD pain using a self-report screener. These questions
include;

1. In the last 30 days, which of the following best describes any pain in your
jaw or temple area on either side?

2. In the last 30 days, have you had pain or stiffness in your jaw on
awakening?

3. In the last 30 days, did the following activities change any pain (that is,
make it better or make it worse) in your jaw or temple area on either side?
Chewing hard or tough food, Opening your mouth or moving your jaw forward or
to the side, Jaw habits such as holding teeth together, clenching/grinding,
or chewing gum, or other jaw activities such as talking, kissing, or yawning

- Frequency of TMD pain more than once a week with pain in the past 6 months

- Electronically sign an informed consent form

Exclusion Criteria:

- An individual who meets any of the following criteria will be excluded from
participation in this study:

- Currently participating in any other TMD and temporomandibular joint (TMJ)
related studies

- Major disk disorder that requires opioids or surgery for TMD pain

- Serious medical condition that might interfere with or prohibit participation in
an online program or pregnancy

- Treatment for a mental health disorder or substance abuse in the past six months