CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Behavioral Intervention Groupbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03896035
NCT03896035N/ACompleted

Improving Outcomes for Older Veterans With Chronic Back Pain and Depression (CDA 14-425)

VA Office of Research and Development·interventional·Posted Mar 29, 2019·Updated Mar 15, 2024

In Brief

A clinical study evaluating Behavioral Intervention Group for Chronic Back Pain and 2 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 29, 2019
Enrollment StartMar 28, 2019
Primary CompletionApr 30, 2022
Study CompletionJun 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.3 years ago

Interventions

Behavioral Intervention Groupbehavioral

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).