RecruitingNot ApplicableNCT06754917

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


Sponsor

Massachusetts General Hospital

Enrollment

30 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria5

  • 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

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Interventions

BEHAVIORALFace-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.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06754917


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