Improving Outcomes for Older Veterans With Chronic Back Pain and Depression

NCT03896035 | Completed Results

• 2 other identifiers: CDX 19-001K2HX001916
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Back Pain; Depression; Aging

Keywords

Chronic Back Pain; Depression; Veterans; Aging

Outcome Measures

Primary Outcomes (1)

• Rate of Intervention Completion

  Feasibility Outcome includes percentage of participants completing each arm

  Through intervention delivery of 8 sessions, up to 24 weeks

Secondary Outcomes (3)

• Pain Scale- PEG-3

  Through study completion, up to 1 year

• Roland Morris Disability Questionnaire (RMDQ)

  Through study completion, up to 1 year

• Depression

  Through study completion, up to 1 year

Study Arms (2)

Waitlist Control Group

NO INTERVENTION

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.

Behavioral Intervention Group

EXPERIMENTAL

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

Interventions

Behavioral Intervention Group 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).

Behavioral Intervention Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Dallas VA Medical Center: collaborator

Study Sites (1)

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

Dallas, Texas, 75216, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This pilot trial was designed to assess feasibility: ability to recruit, refine protocols and procedures and retain participants. The pilot trial was active during 2019-2020 when COVID restrictions were severe, locally, and several participants in the active arm were lost to follow-up for health related reasons.

Results Point of Contact

• Title: Una Makris, MD (PI)
• Organization: VANTHCS

una.makris2@va.gov

2148570240

Study Officials

• Una E. Makris, MD MSc

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research staff conducting outcomes assessments will be blinded to whether the subject is in active or waitlist group
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This pilot RCT will use a waitlist control

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: March 29, 2019
• Study Start: March 28, 2019
• Primary Completion: April 30, 2022
• Study Completion: June 30, 2022
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)