Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06366633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-28
Brief Title:
Web-based Mind-body Program for Comorbid Nontraumatic Upper-extremity Condition and Risky Substance Use
Sponsor:
Jafar Bakhshaie
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Feasibility Open Pilot of Web-based Mind-body Treatment to Enhance Resilience Among Patients With Nontraumatic Painful Upper Extremity Conditions and Comorbid Risky Substance Use
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigator aims to conduct an open pilot study N12 10 completers to test the feasibility acceptability and credibility of an asynchronous web-based mind-body intervention Toolkit for Resilient Life beyond Pain and Substance Use Web-TIRELESS for adult patients with a comorbidity of non-traumatic painful upper-extremity conditions NPUC and risky substance use
Deliverables 1 Adapt and refine open pilot protocol patient recruitment and other study materials 2 Assess the feasibility acceptability and credibility of Web- TIRELESS in preparation for a future feasibility RCT
Participants will complete 4 on-demand video sessions at their own pace approximate pace of 1 session per week and complete baseline and post-test assessments participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations
Deliverables 1 Adapt and refine open pilot protocol patient recruitment and other study materials 2 Assess the feasibility acceptability and credibility of Web- TIRELESS in preparation for a future feasibility RCT
Participants will complete 4 on-demand video sessions at their own pace approximate pace of 1 session per week and complete baseline and post-test assessments participants may also partake in an exit interview to provide feedback on Web-TIRELESS to further refine the program and study protocol for future iterations
Detailed Description:
Aim Conduct a pilot study N12 10 completers of Web-TIRELESS followed by virtual exit interviews with adult patients with painful nontraumatic upper extremity conditions and comorbid risky substance use The investigators will use this mixed methods information to assess the feasibility credibility and acceptability of Web-TIRELESS and optimize the program and study methodology in preparation for a pilot feasibility randomized control trial RCT
The Web-TIRELESS program adapted from the Toolkit for Optimal Recovery P 2020P000095 consists of 4 on-demand video sessions each being approximately 30-45 minutes long The sessions aim to teach mind-body skills cognitive-behavioral strategies eg reframing pain and substance use urge surfing activity pacing acceptance and commitment skills and psychoeducation on the association between substance use and pain Each session will consist of a combination of short 5-10 min educational videos exercises and guided home practice goal-setting At the end of each session each participant will complete an interactive quiz that covers the subject of the session to facilitate deeper understanding and internalization of the session content The interactive quiz format has been demonstrated to be useful for learning new information including among orthopedic patients Between sessions participants will be encouraged to practice program skills at home Home practice materials include Web-based audio and video clips eg 5 min mindfulness of pain and substance urge Outside the on-demand sessions participants will continue to use the web-based platform to guide and log their home practice
After completion of the program participants will attend a one-time 15-30 minute exit interview to share their perceptions of Web-TIRELESS and any recommendations to improve quality This information will be used to further adapt and optimize Web-TIRELESS prior to future study phases
Assessments Participants will complete baseline and post-test assessments
The Web-TIRELESS program adapted from the Toolkit for Optimal Recovery P 2020P000095 consists of 4 on-demand video sessions each being approximately 30-45 minutes long The sessions aim to teach mind-body skills cognitive-behavioral strategies eg reframing pain and substance use urge surfing activity pacing acceptance and commitment skills and psychoeducation on the association between substance use and pain Each session will consist of a combination of short 5-10 min educational videos exercises and guided home practice goal-setting At the end of each session each participant will complete an interactive quiz that covers the subject of the session to facilitate deeper understanding and internalization of the session content The interactive quiz format has been demonstrated to be useful for learning new information including among orthopedic patients Between sessions participants will be encouraged to practice program skills at home Home practice materials include Web-based audio and video clips eg 5 min mindfulness of pain and substance urge Outside the on-demand sessions participants will continue to use the web-based platform to guide and log their home practice
After completion of the program participants will attend a one-time 15-30 minute exit interview to share their perceptions of Web-TIRELESS and any recommendations to improve quality This information will be used to further adapt and optimize Web-TIRELESS prior to future study phases
Assessments Participants will complete baseline and post-test assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23AT012364-01 | NIH | None | httpsreporternihgovquickSearch1K23AT012364-01 |