Improving Outcomes for Older Veterans With Chronic Back Pain and Depression

Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (CDA 14-425)

The overarching goal of this study is to develop and evaluate a telephone delivered behavioral change intervention for older Veterans with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related pain, depressive symptoms, and disability.

Investigators will conduct a pilot randomized controlled trial to assess feasibility for older Veterans with cLBP and depression assigned to receive the behavioral interventions (n=25) versus waitlist control (n=25). For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.

Study Overview

• Status: Completed
• Conditions: Depression; Aging; Chronic Back Pain
• Intervention / Treatment: Behavioral: Behavioral Intervention Group

Detailed Description

In this pilot RCT, investigators will assess the feasibility for older Veterans with cLBP and depression assigned to receive the behavioral intervention (n=25) versus the waitlist control (n=25). Follow-up will also include assessments at 6 months and 12 months post-intervention.

Overview of Proposed intervention: The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed). Exceptions may be made for highly motivated subjects who had unfortunate life circumstances arise.

For the physical activity component of the intervention, investigators will provide an Omron pedometer to subjects, as previously used in VA research studies. The Omron pedometer will be set up by the research team (stride length, setting date/time) and will be mailed to the subject's home in between session 1 and 2. The health coach will remind the subject that this pedometer will arrive via United States Postal Service mail to their home and to call the research coordinator when it arrives. The research team will provide technical assistance and instructions to the subject regarding use of the Omron pedometer (to be worn on the waist band, daily, all day aside from showers/baths). The research team will also verbally show the subject how to press the mode and memory buttons to obtain weekly step counts for documentation/tracking physical activity. The subjects will be prompted by the health coach or research staff to report out weekly step counts during subsequent coaching sessions.

In addition to the assessments outlined later in this protocol, specifically at 12 months, investigators will conduct in-depth semi-structured interviews with ~10-15 participants (8 from both arms of the pilot trial, the health coaches, 2 primary care providers, and 1 mental health provider) using purposive sampling. The health coach/research coordinator will identify Veterans who are at higher risk for drop-out, were less engaged, or were particularly successful at achieving behavioral change. The purpose of this final interview is to learn about the barriers and facilitators to successful intervention delivery and participant retention from the Veteran, health coach, and provider perspective.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75216
      • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women Veterans aged 65+
• English-speaking
• Self-reported low back pain (+/-radiation) on most days for the past 3 months, that interferes with daily activities. Low back pain interferes with daily activities, assessed with the question "does your back pain limit your ability to do activities around the home or activities that you enjoy?"
• Chronic low back pain with intensity of 4 or higher on 10 point scale
• Depression, PHQ-9>10 stable (per chart review, no psychotic or suicidal ideation; confirmed over telephone)
• Capable of participating in home-based activity

Exclusion Criteria:

• No telephone
• Not English speaking
• Unwilling to be randomized to either study arm
• Self-reported uncorrected hearing or visual disturbance precluding ability to participate in telephone sessions or read pedometer screen
• Cognitive impairment, assessed by Memory Impairment Screen
• Lumbar surgery within the last year
• Self-reported dependence on wheelchair, bed-bound, or severe balance impairment (unable to participate in physical activity intervention)
• Illness requiring hospitalization within the last 3 months. Specific question: Have you been hospitalized for an illness in the past 3 months that would make participating in a physical activity program challenging or unsafe? (Examples include: fall, gout attacks, stroke, heart attack, heart failure, or surgery for blocked arteries)
• Suicidal ideation, prior psychotic episodes requiring hospitalization within the last year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waitlist Control Group; The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.
Experimental: Behavioral Intervention Group; For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant.	Behavioral: Behavioral Intervention Group; The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Intervention Completion	Feasibility Outcome includes percentage of participants completing each arm	Through intervention delivery of 8 sessions, up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Questionnaire (RMDQ)	Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain	Through study completion, up to 1 year
Depression	Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression	Through study completion, up to 1 year
Pain Scale- PEG-3	Pain intensity on 0-10 scale where higher values are worse pain; PEG-3 assesses 3 aspects of pain interference and averages these values	Through study completion, up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step counts	Physical activity: step counts measured using Omron pedometer. Participants will wear the pedometer clipped to their right lateral waistband for 24 hours per day for 7 consecutive days (except during shower or water activities) to obtain 5 complete days of physical activity data	Through 8 intervention sessions, up to 24 weeks

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Dallas VA Medical Center
• Investigators: Principal Investigator: Una E. Makris, MD MSc, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 5, 2019
• First Submitted That Met QC Criteria: March 28, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Veterans; Aging; Chronic Back Pain
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pain; Neurologic Manifestations; Depression; Depressive Disorder; Back Pain
• Other Study ID Numbers: CDX 19-001; K2HX001916 (Other Identifier: VA HSRD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No