E-health Resilience Program For Chronic Spine Pain

Neck Pain Clinical Trial

— JOOL  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03667040
• Other study ID #: HUM00146178
• Status: Terminated
• Phase: N/A
• Start date: August 9, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: July 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Neck Pain

Intervention

Behavioral:
• JOOL app
Participants will use the JOOL app for 30 days

Locations

Country	Name	City	State
United States	Back & Pain Center, University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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