A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Michigan
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
Study Overview
Brief Summary
This study will examine a e-health resilience based program, JOOL, for chronic spine pain patients through the following aims:
Aim 1: To test the effectiveness of a resilience based program known as JOOL Aim 2: To evaluate the characteristics of the participants most likely to benefit from this treatment
Detailed Description
This is a pilot RCT in which 150 patients with chronic spine pain will be randomized to one of two arms: (1) a group that downloads the JOOL mobile application resilience program; and (2) a control group.The primary outcome will be a change in physical function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient of the UM Back & Pain Center
- •Primary diagnosis of neck or back pain (spine pain)
- •Age 18-70
- •English speaking
- •Able to provide consent
- •Willing to download the mobile application and comply with study procedures
- •Antidepressant medications stable for ≥ 4 weeks
- •No plan to initiate a new non-pharmacological pain intervention during the 30-day study period (e.g. back surgery, physical therapy, behavioral therapy
Exclusion Criteria
- •Having known psychotic disorder or the presence of another psychiatric condition (e.g. severe depression [HADS scores ≥ 15], suicidal ideation) or cognitive impairment (e.g. severe dyslexia, TBI) limiting ability to give consent and/or participate fully in the study
- •Currently undergoing psychotherapeutic care at the Back & Pain Center because many of the concepts that are the focus of this study are already employed in that treatment
- •Other factors that at the discretion of the investigators would adversely affect study participation.
Arms & Interventions
Control Group
75 participants will take part in three visits (baseline, 30days and 60days)
Intervention
75 participants will take complete a baseline visit and then participate in the intervention. They will use the application, the JOOL app for 30 days. Then complete surveys at 30days and 60days after the interventions
Intervention: JOOL app (Behavioral)
Outcomes
Primary Outcomes
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
Time Frame: 2 month
10 item survey measuring physical function. Each question is measured on a scale of 1-5. The lowest score being 10 and highest score is 50. A higher score correlates with poor physical functioning.
Secondary Outcomes
No secondary outcomes reported
Investigators
Afton Hassett, Psy.D.
Principal Investigator
University of Michigan