E-health Resilience Program For Chronic Spine Pain

NCT03667040 | Terminated

• 1 other identifier: HUM00146178
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Conditions

Back Pain; Neck Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

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

Intervention

ACTIVE COMPARATOR

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

Interventions

JOOL app BEHAVIORAL

Participants will use the JOOL app for 30 days

Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Back & Pain Center, University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Afton Hassett, PsyD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 12, 2018
• Study Start: August 9, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: August 7, 2019

Record last verified: 2019-07

Locations

US (1)