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

Sponsored by Massachusetts General Hospital

About this trial

Last updated a month ago

Study ID

2024P003501

Status

Active not recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 18 Years

All Sexes

Trial Timing

Started 8 months ago

What is this trial 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).

What are the participation requirements?

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