Clinical trial NCT06754917: Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain
Official title: Feasibility Testing of the "Face-Forward-Web" Program for Chronic Orofacial Pain
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Orofacial Pain
Facial Pain
Keywords: Chronic orofacial pain
Facial Pain
Mindfulness
web-based delivery
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2025-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: NIH Stage Model for Behavioral Intervention Development
Primary purpose: OTHER

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).

Detailed description: 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.

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

Primary outcomes:
measure: Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire
timeFrame: Baseline (0 Weeks)
measure: Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale
timeFrame: Post-Test (5 Weeks)
measure: Feasibility of recruitment
timeFrame: Baseline (0 Weeks)
measure: The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery
timeFrame: Post-Test (5 Weeks)
measure: Rate at which program was accepted, measured by number of completed program sessions
timeFrame: Post-Test (5 Weeks)
measure: Adherence to homework
timeFrame: Collected during intervention, an average of 5 weeks
measure: Feasibility of Assessments at Baseline
timeFrame: Baseline (0 Weeks)
measure: Feasibility of Assessments at Post-Test
timeFrame: Post-Test (5 Weeks)
measure: Feasibility of Assessments at Follow-Up
timeFrame: Follow-Up (17 Weeks)
measure: Adverse Events
timeFrame: Collected during intervention, an average of 5 weeks
Secondary outcomes:
Other outcomes:
measure: Graded Chronic Pain Scale (GCPS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Applied Mindfulness Process Scale (AMPS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Cognitive And Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Tampa Scale for Kinesiophobia for Temporomandibular Disorders (TSK-TMD)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Patient Health Questionnaire - Depression (PHQ-9)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline (0 Weeks), Post-Test (5 Weeks), Follow-Up (17 Weeks)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: