Ignite Creation Date:
2024-05-06 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03465826
Status:
WITHDRAWN
Last Update Posted:
2021-03-15
First Post:
2018-02-02
Brief Title:
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine AIM 4
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine Testing Feasibility Acceptability and Utility AIM 4
Status:
WITHDRAWN
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This ClinicalTrialsgov record pertains only to the clinical trial described below in Aim 4 Aims 1-3 and 5 are described here as background information This study will be a two-site collaborative research effort Wake Forest Duke Univ drawing on expertise of investigators steeped in PCST Internet-based treatment delivery and development of cost-efficient and maximally-accessible behavioral interventions for migraine and chronic pain This research will address four specific aims via a mixed-methods approach In Aim 1 subjects n20 will be recruited to participate in user testing of the extant program PainCOACH1 In Aim 2 subjects n64 including migraineurs members of migraine patient advocacy groups and clinical professionals trained in headache medicine will participate in focus groups to provide guidance for appropriately tailoring the program for the treatment of chronic migraine In Aim 3 feedback from Aims 1 and 2 will be employed to build and develop PainCOACH Migraine which will be beta-tested and refined In Aim 4 subjects n144 will be recruited to participate in a randomized controlled trial of the PainCOACH Migraine program versus Medical Treatment as Usual to demonstrate its feasibility acceptability and engagement and promise Guided by findings from these aims a final exploratory aim will be conducted to optimize the program using prediction models to identify patients at risk for poor outcomes or attrition and an adaptive therapeutic process targeting improved outcomes for such patients Ultimately these research efforts will provide data and experience needed to support a subsequent large-scale and methodologically rigorous adaptive trial to test PainCOACH Migraine and enhance understanding of the potentials for Internet-based delivery of behavioral programs for individuals with chronic migraine
Detailed Description:
In addition to experiencing chronic pain disability and diminished quality of life individuals with chronic migraine face critical access barriers to traditional validated clinic-based behavioral headache treatments eg availability of trained therapists cost absences from work Internet-based and mHealth technologies show promise for the treatment of chronic pain conditions and are primed to address barriers to treatment but have not yet been optimally translated into interventions for chronic migraine A program of development is proposed to transform a validated 8-week Internet-based pain-coping skills training PCST program PainCOACH I original into a version specific for chronic migraine
PainCOACH I was designed to retain key therapeutic components of in-clinic protocols and includes 8 modules of self-directed tailored interactive training in cognitive behavioral pain coping skills A virtual coach provides verbal and visual instruction feedback and encouragement guided by theoretically-based learning principles PainCOACH I has been successfully tested for populations with osteoarthritis and cancer pain and has been studied in the US and Australia
This clinical trial registration pertains only to Aim 4 of the study In Aim 4 subjects n144 will be recruited to participate in a randomized controlled trial of the PainCOACH Migraine program versus Medical Treatment as Usual to demonstrate its feasibility acceptability and engagement and promise
PainCOACH I was designed to retain key therapeutic components of in-clinic protocols and includes 8 modules of self-directed tailored interactive training in cognitive behavioral pain coping skills A virtual coach provides verbal and visual instruction feedback and encouragement guided by theoretically-based learning principles PainCOACH I has been successfully tested for populations with osteoarthritis and cancer pain and has been studied in the US and Australia
This clinical trial registration pertains only to Aim 4 of the study In Aim 4 subjects n144 will be recruited to participate in a randomized controlled trial of the PainCOACH Migraine program versus Medical Treatment as Usual to demonstrate its feasibility acceptability and engagement and promise
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