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MOTIVATE: Moving to Improve Outcomes for Older Adults

NCT03914469 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-03-14

Study results available
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Summary

The overarching goal of this study is to evaluate a tele-based behavioral change intervention for older adults (aged 50 years and older) with chronic low back pain (cLBP) and comorbid depression, and to ultimately assess its effect on cLBP-related disability and depressive symptoms.

Investigators will conduct a pilot randomized control trial to assess feasibility for older adults with chronic low back pain and depression to receive a behavioral change tele-based intervention delivered by a health coach trained in motivational interviewing. All participants, regardless of intervention arm assigned, will undergo outcomes assessments (baseline, mid-point, final assessments) conducted by a blinded research assistant.

Conditions

  • Back Pain Lower Back Chronic

Interventions

BEHAVIORAL

Behavioral Intervention Group

The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews at 6 months post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Una Makris, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-11-07
Completion
2022-12-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914469 on ClinicalTrials.gov