E-health Resilience Program For Chronic Spine Pain

Not Applicable

Terminated

• Conditions: Back Pain; Neck Pain
• Interventions: Behavioral: JOOL app

• Registration Number: NCT03667040
• Lead Sponsor: University of Michigan

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 Timeline

• Study Start: 2018-08-09
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-12
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Status Verified: 2019-07
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	JOOL app	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

Primary Outcome Measures

Name	Time	Method
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10	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.

Trial Locations

Locations (1)

Back & Pain Center, University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States