N/A
Completed N=50
Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
Source: ClinicalTrials.gov NCT03896035 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Rate of Intervention Completion — 22; 15 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Intervention Completion |
22; 15 | — |
| SECONDARY Pain Scale- PEG-3 |
6.57; 5.13 | — |
| SECONDARY Roland Morris Disability Questionnaire (RMDQ) |
17.10; 13.07 | — |
| SECONDARY Depression |
10; 7.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT03896035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.