Journaling Intervention for Temporomandibular Disorder (TMD) and Chronic Overlapping Pain

January 5, 2026 updated by: University of Florida

Examining the Feasibility and Acceptability of a Journaling Intervention in Alleviating Temporomandibular Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gratitude Intervention
Behavioral: Gratitude
Participants in this group will receive a gratitude journal where they will be asked to write down three things they are grateful for each day and reflect why they are grateful for these things. Journaling will take place from the comfort of their home on three days of their choice per week, for a total duration of two weeks.
Active Comparator: General Wellness
Other: General Wellness
Participants in this group will receive a general wellness journal where they will be asked to reflect on three things that happened, or they did during the day (daily activities). Journaling will take place from the comfort of their home on three days of their choice per week, for a total duration of two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Retention
Time Frame: Baseline to Week 4
Percentage of participants who initiate treatment/intervention and complete the post-intervention assessment at the 4-week time-point.
Baseline to Week 4
Treatment Satisfaction
Time Frame: Week 4
Single-item Treatment Satisfaction Questionnaire: Response to self-reported item assessing overall satisfaction with the treatment. The item is rated on a 1 to 4 scale (1 = Quite Dissatisfied to 4 = Very Satisfied) with the mean value calculated. A higher score indicates greater satisfaction with the treatment.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: Baseline, Week 4
The PROMIS-Pain Intensity short form is a 3-item measure assessing pain intensity over the past 7 days (i.e., "how intense was your pain at its worst"), as well as current level of pain. The total score for the PROMIS Pain Intensity short form will be calculated by summing the numerical values of the responses to each of the three items. After obtaining the total raw score, it will then be converted into a T-score, which standardizes the score with a mean of 50 and a standard deviation of 10, based on the general U.S. population.
Baseline, Week 4
Pain Interference
Time Frame: Baseline, Week 4
The PROMIS-Pain Interference short form is an 8-item measure assessing the extent to which pain interferes with physical, mental, cognitive, emotional, recreational and social activities over the past 7 days (i.e., "how much did pain interfere with work around home"). The total score for the PROMIS-Pain Interference short form will be calculated by summing the numerical values of the responses to each of the eight items. After obtaining the total raw score, it will then be converted into a T-score, which standardizes the score with a mean of 50 and a standard deviation of 10, based on the general U.S. population.
Baseline, Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 8, 2025

First Posted (Actual)

May 18, 2025

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202500344

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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