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

NCT06977100 | Recruiting

• 1 other identifier: IRB202500344
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular Disorder; Gratitude Journaling; Resilience; Pain Intensity; Pain Interference; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Participant Retention

  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

  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 Outcomes (2)

• Pain Intensity

  Baseline, Week 4

• Pain Interference

  Baseline, Week 4

Study Arms (2)

Gratitude Intervention

EXPERIMENTAL

Behavioral: Gratitude

General Wellness

ACTIVE COMPARATOR

Other: General Wellness

Interventions

General Wellness OTHER

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.

General Wellness

Gratitude BEHAVIORAL

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.

Gratitude Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Melissa Makhoul, PhD, MSN, RN

CONTACT

352-246-3153; melissamakhoul@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 18, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)