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Completed NCT06754917

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

Conditions: Orofacial Pain, Facial Pain

Sex: All
Ages: 18 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Massachusetts General Hospital

Location: Massachusetts General Hospital Boston Massachusetts

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 Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06754917). StuddyBuddy aggregates publicly available trial information.