Improving Outcomes for Older Veterans With Chronic Back Pain and Depression

NCT ID: NCT03896035

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2022-06-30

Brief Summary

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.

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.

Conditions

Chronic Back Pain; Depression; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Behavioral Intervention Group

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dallas VA Medical Center

FED

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Una E. Makris, MD MSc

Role: PRINCIPAL_INVESTIGATOR

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Locations

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K2HX001916

Identifier Type: OTHER

Identifier Source: secondary_id

CDX 19-001

Identifier Type: -

Identifier Source: org_study_id