Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
CompletedNot applicableNCT03896035
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (CDA 14-425)
- Conditions
- Interventions
- Behavioral: Behavioral Intervention Group
- Sponsor
- VA Office of Research and Development
- Collaborators
- Dallas VA Medical Center
- Start date
- 2019-03-28
- Primary completion
- 2022-04-30
- Sex
- All
- Age range
- from 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03896035