Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain

Mass General Brigham

Status: Enrolling

Conditions: Orofacial Pain; Facial Pain

Treatments: Behavioral: Face-Forward-Web

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06754917

1R21DE033502-01A1 (U.S. NIH Grant/Contract)

2024P003501

Details and patient eligibility

About

The goal of this study is to conduct a feasibility open pilot study (N=Up to 20) with exit interviews to assess the feasibility, acceptability, and credibility of the study protocol and Face-Forward-Web; a web-based mind-body intervention for adult patients with COP.

Deliverables: [1] Adapt and refine open pilot protocol, patient recruitment, and other study materials. [2] Assess the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention methodology in preparation for a future efficacy study.

This research leverages mixed methods information to evaluate the feasibility, acceptability, and credibility of Face-Forward-Web and optimize the intervention and study methodology in preparation for the subsequent pilot study and again later, for a pilot feasibility randomized control trial (RCT).

Full description

Aim: Conduct a feasibility open pilot study (N=Up to 20) with exit interviews of Face-Forward-Web among adults with various chronic orofacial pain (COP). The ultimate goal of this research is to assess the feasibility, credibility, and acceptability of Face-Forward-Web and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial (RCT).

Face-Forward-Web, adapted from GetActive (a mind-body program for patients with chronic musculoskeletal pain), is a mind-body program for COP and consists of 5 on-demand sessions over a web platform, each being approximately 30 minutes long. The program will teach relaxation (deep breething), mindfulness, and cognitive-behavioral skills to reduce pain and improve emotional welbeing in patients with COP. At the conclusion of each session, an interactive quiz covering the session's content is given to foster a stronger, and more long term, understanding of the material. Throughout the program, encouragements to practice and track the use of Face-Forward-Web skills are disseminated outside and/or between sessions through a variety of means (e.g, text, phone call, email), depending on individual preferenes. Home practice materials include Web-based audio and video clips (e.g., 5 min mindfulness of pain for COP) but, engagement in self-guided skill practice is also permitted.

Following program completion, there will be a one-time 15-30 minute exit interview to elicit subject perceptions of Face-Forward-Web and any recommendations to improve intervention quality. This information will be used to further adapt and optimize Face-Forward-Web prior to future efficacy testing.

Assessments: Baseline (0 weeks), post-test (5 weeks), and 3-month follow-up (17 weeks) survey assessments.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18
2. English fluency and literacy
3. Nonmalignant chronic (>3 months) orofacial pain
4. Ability and willingness to participate in the Face-Forward web-platform intervention
5. Free of concurrent psychotropic medication 2 week prior to participation OR stable psychotropic medication dose and type for ≥ 6 weeks
6. Pain score ≥4/10 on the Numerical Rating Scale
7. Owns (or has easy access to) a device with internet access

Exclusion criteria

1. Practice of mindfulness > 45 minutes/week in the past 3 months
2. Participation in mind-body or cognitive-behavioral therapy in the past 3 months
3. Severe untreated mental health disorder (e.g., psychosis)
4. Active suicidal ideation with plan or intent
5. Pregnancy

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Face-Forward-Web

Experimental group

Description:

A 5-session web-based mind-body pain management intervention focused on decreasing pain and disability (physical and emotional) among adult patients with chronic orofacial pain.

Treatment:

Behavioral: Face-Forward-Web