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

NCT ID: NCT06754917

Last Updated: 2025-10-24

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2026-09-01

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Orofacial Pain Facial Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

NIH Stage Model for Behavioral Intervention Development
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Face-Forward-Web

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.

Group Type EXPERIMENTAL

Face-Forward-Web

Intervention Type BEHAVIORAL

This is a self-administered web-based mind-body intervention that consists of 5 30-minute video sessions disseminating tailored relaxation, mindfulness, and cognitive-behavioral skills for COP. Ultimately, the Face-Forward-Web program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive coping behaviors.

Interventions

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Face-Forward-Web

This is a self-administered web-based mind-body intervention that consists of 5 30-minute video sessions disseminating tailored relaxation, mindfulness, and cognitive-behavioral skills for COP. Ultimately, the Face-Forward-Web program aims to increase patients' physical and emotional functioning and decrease pain intensity and maladaptive coping behaviors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jonathan Greenberg

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan Greeberg, PhD

Role: CONTACT

617-643-9402

Kozbi Bayne-Cliff, BS

Role: CONTACT

(617) 643-8678

Facility Contacts

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Jonathan Greenberg, PhD

Role: primary

617-643-9602

References

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Lovette BC, Bakhshaie J, Kulich R, Shaefer JR, Cheng HT, He S, Vranceanu AM, Greenberg J. Development of a Novel Web-Based Intervention Targeting Pain-Related Outcomes in Individuals With Chronic Orofacial Pain: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2025 Aug 20;14:e71839. doi: 10.2196/71839.

Reference Type DERIVED
PMID: 40835226 (View on PubMed)

Other Identifiers

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1R21DE033502-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2024P003501

Identifier Type: -

Identifier Source: org_study_id

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