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

NCT06754917 | Active Not Recruiting

• 2 other identifiers: 2024P0035011R21DE033502-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Orofacial Pain; Facial Pain

Keywords

Chronic orofacial pain; Facial Pain; Mindfulness; web-based delivery

Outcome Measures

Primary Outcomes (10)

• Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire

  Assessed using the Credibility and Expectancy Questionnaire which asks the participant to indicate how much they believe, right now, that the intervention they will receive will help manage their COP and related worry. Possible scores range from 3 to 27 for both the credibility and the expectancy subscales. Higher scores represent higher credibility and expectancy.

  Baseline (0 Weeks)

• Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale

  Measured using the Client Satisfaction Scale which assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.

  Post-Test (5 Weeks)

• Feasibility of recruitment

  The percent of eligible patients approached that agree to participate.

  Baseline (0 Weeks)

• The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery

  This measure will assess how well patients like the Wed-based program content and delivery. Total raw scores range from 22 to 110 with higher scores indicating greater satisfaction with the platform.

  Post-Test (5 Weeks)

• Rate at which program was accepted, measured by number of completed program sessions

  The proportion of participants who complete \> or = 3 of 5 sessions.

  Post-Test (5 Weeks)

• Adherence to homework

  Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study

  Collected during intervention, an average of 5 weeks

• Feasibility of Assessments at Baseline

  Rate of participant's completion of self-report measures, with no measures missing.

  Baseline (0 Weeks)

• Feasibility of Assessments at Post-Test

  Rate of participant's completion of self-report measures, with no measures missing.

  Post-Test (5 Weeks)

• Feasibility of Assessments at Follow-Up

  Rate of participant's completion of self-report measures, with no measures missing.

  Follow-Up (17 Weeks)

• Adverse Events

  Any self-reported or observed negative events related to participation

  Collected during intervention, an average of 5 weeks

Other Outcomes (8)

• Graded Chronic Pain Scale (GCPS)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)

• Applied Mindfulness Process Scale (AMPS)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)

• Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)

  Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)

Study Arms (1)

Face-Forward-Web

EXPERIMENTAL

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.

Behavioral: Face-Forward-Web

Interventions

Face-Forward-Web 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.

Face-Forward-Web

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 40835226 DERIVED

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: NIH Stage Model for Behavioral Intervention Development

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)