Clinical trial NCT06977100: Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain
Official title: Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Disorders (TMD)
Keywords: Temporomandibular Disorder
Gratitude Journaling
Resilience
Pain Intensity
Pain Interference
Chronic Pain
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn whether a 2-week gratitude journaling activity is feasible and acceptable for individuals with Temporomandibular Disorder (TMD) and chronic overlapping pain. The study will also look at whether this activity is helpful in reducing pain and how much it interferes with daily life.

The primary aims of this study are to:

* Assess whether individuals with TMD and chronic overlapping pain are able to complete the 2-week gratitude journaling activity as planned (feasibility).
* Evaluate how acceptable participants find the gratitude journaling activity (acceptability).

The secondary aim of this study is to:

• Explore whether the gratitude journaling activity reduces pain and its impact on daily life, compared to a general wellness journaling activity.

Participants will:

* Attend two in-person visits to complete questionnaires and take part in tests that measure how sensitive they are to pressure and heat.
* Complete a 2-week journaling activity at home, writing in their journal on three days of their choice per week.


Eligibility criteria: Inclusion Criteria:

* participants between the ages of 18 and 80
* pain in the temporomandibular (TMD) region (jaw and/or temple area)
* duration of pain is at least 3 months
* average pain score ≥4 on a 0-10 numerical rating scale over the past week
* have at least one additional chronic overlapping pain condition (COPC) including fibromyalgia, irritable bowel syndrome, migraine-type headache, tension-type headache, low back pain, interstitial cystitis/painful bladder syndrome or chronic prostatitis, myalgic encephalomyelitis/chronic fatigue syndrome, vulvodynia, and painful endometriosis.
* able to read, understand, and write in English.

Exclusion Criteria:

* history of TMD surgery
* neoplasm or injury/trauma to the TMD area
* cancer-related pain
* scheduled for any surgeries during the study time-frame
* current participation in another clinical trial or psychological treatment for any pain-related condition that would interfere with study outcomes
* pregnant or lactating
* severe motor impairments (e.g., muscular dystrophy)
* severe psychiatric conditions (e.g., uncontrolled mood disorders)
* severe neurological or cognitive impairments (e.g., uncontrolled Parkinson's disease)
* any other conditions that in the opinion of study investigators could make participation in the study unsafe
* use of opioids within 48 hours prior to laboratory visit

Primary outcomes:
measure: Participant Retention
timeFrame: Baseline to Week 4
measure: Treatment Satisfaction
timeFrame: Week 4
Secondary outcomes:
measure: Pain Intensity
timeFrame: Baseline, Week 4
measure: Pain Interference
timeFrame: Baseline, Week 4
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References: