Facial Pain, Orofacial Pain
Conditions
Keywords
Chronic orofacial pain, Facial Pain, Mindfulness, web-based delivery
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.
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.
Sponsors
Massachusetts General Hospital
National Institute of Dental and Craniofacial Research (NIDCR)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
NIH Stage Model for Behavioral Intervention Development
Eligibility
Sex/Gender
ALL
Age
18 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Scored Above the Midpoint on Each Subscale of the Credibility and Expectancy Questionnaire | Baseline (0 Weeks) | 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. |
| Proportion of Participants Who Scored Above the Midpoint on the Client Satisfaction Scale | Post-Test (5 Weeks) | 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. |
| Feasibility of recruitment | Baseline (0 Weeks) | The percent of eligible patients approached that agree to participate. |
| The User Experience Scale to assess participants' satisfaction with (acceptability of) web-based delivery | Post-Test (5 Weeks) | 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. |
| Rate at which program was accepted, measured by number of completed program sessions | Post-Test (5 Weeks) | The proportion of participants who complete \> or = 3 of 5 sessions. |
| Adherence to homework | Collected during intervention, an average of 5 weeks | Rate of participant's completion of homework assigned (practicing at least 1 program skill, 3 days/week on average) throughout the study |
| Feasibility of Assessments at Baseline | Baseline (0 Weeks) | Rate of participant's completion of self-report measures, with no measures missing. |
| Feasibility of Assessments at Post-Test | Post-Test (5 Weeks) | Rate of participant's completion of self-report measures, with no measures missing. |
| Feasibility of Assessments at Follow-Up | Follow-Up (17 Weeks) | Rate of participant's completion of self-report measures, with no measures missing. |
| Adverse Events | Collected during intervention, an average of 5 weeks | Any self-reported or observed negative events related to participation |
Countries
United States
Outcome results
None listed