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

NCT ID: NCT06977100

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Disorders (TMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gratitude Intervention

Group Type EXPERIMENTAL

Gratitude

Intervention Type 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.

General Wellness

Group Type ACTIVE_COMPARATOR

General Wellness

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Melissa Makhoul, PhD, MSN, RN

Role: CONTACT

352-246-3153

Facility Contacts

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Melissa Makhoul, Phd, MSN, RN

Role: primary

352-246-3153

Other Identifiers

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IRB202500344

Identifier Type: -

Identifier Source: org_study_id

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