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E-health Resilience Program For Chronic Spine Pain (JOOL)

Primary Purpose

Back Pain, Neck Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
JOOL app
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Back & Pain Center, University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Intervention

Arm Description

75 participants will take part in three visits (baseline, 30days and 60days)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 7, 2018
Last Updated
August 5, 2019
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03667040
Brief Title
E-health Resilience Program For Chronic Spine Pain
Acronym
JOOL
Official Title
A Randomized Controlled Trial of an E-health Resilience Program For Chronic Spine Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
August 9, 2018 (Actual)
Primary Completion Date
March 15, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
75 participants will take part in three visits (baseline, 30days and 60days)
Arm Title
Intervention
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
JOOL app
Intervention Description
Participants will use the JOOL app for 30 days
Primary Outcome Measure Information:
Title
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function Scale- Short form 10
Description
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.
Time Frame
2 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Afton Hassett, PsyD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Back & Pain Center, University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

E-health Resilience Program For Chronic Spine Pain

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