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Improving Outcomes for Older Veterans With Chronic Back Pain and Depression
NA trial testing Behavioral Intervention Group in Chronic Back Pain in 50 participants. Completed in 30 June 2022.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | health services research |
| Enrollment | 50 |
| Start date | 28 March 2019 |
| Primary completion | 30 April 2022 |
| Estimated completion | 30 June 2022 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
65 and older, any sex, with Chronic Back Pain or Depression. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Feasibility Outcome includes percentage of participants completing each arm
| Group | Value | 95% CI |
|---|---|---|
| Waitlist Control Group | 22 | |
| Behavioral Intervention Group | 15 |
Pain intensity on 0-10 scale where higher values are worse pain; PEG-3 assesses 3 aspects of pain interference and averages these values
| Group | Value | 95% CI |
|---|---|---|
| Waitlist Control Group | 6.57 | ± 1.89 |
| Behavioral Intervention Group | 5.13 | ± 2.04 |
Disability related to back pain. Scale ranges from 0-24 with larger numbers indicating worse disability related to chronic back pain
| Group | Value | 95% CI |
|---|---|---|
| Waitlist Control Group | 17.10 | ± 4.05 |
| Behavioral Intervention Group | 13.07 | ± 4.22 |
Depression: Patient Health Questionnaire (PHQ-9) scored between 0-27 with higher numbers indicated worse depression
| Group | Value | 95% CI |
|---|---|---|
| Waitlist Control Group | 10 | ± 4.35 |
| Behavioral Intervention Group | 7.4 | ± 4.90 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03896035.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing