E-health Resilience Program For Chronic Spine Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain

Conditions
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Back Pain, Neck Pain

Intervention / Treatment
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* Behavioral: JOOL app


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 150 participants will be recruited; 75 participants into the intervention group and 75 into the control group. There will three visits, baseline and follow-up at 30 days and 60 days.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>75 participants will take part in three visits (baseline, 30days and 60days) | |
| Active Comparator: Intervention<br>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 | Behavioral: JOOL app<br>* Participants will use the JOOL app for 30 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10 | 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. | 2 month |