RECRUITING

MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

Conditions

Chronic Back Pain Depression Aging Musculoskeletal Pain Veterans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed study seeks to evaluate effectiveness, implementation processes, and cost of MOTIVATE among older Veterans with chronic musculoskeletal (MSK) pain and comorbid depressive symptoms.

Official Title

MOTIVATE to Improve Outcomes for Older Veterans With Musculoskeletal Pain and Depression

Quick Facts

Study Start:2023-09-20

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05220202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Aged 60 and older * English- speaking * Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities * Pain intensity that is 4+/10 on the numerical pain rating scale * Pain interference threshold 5+ on PEG-3 * Depressive symptoms, 10+ on PHQ-9 * Capable of participating in home-based activity * Interested in participating in a non-pharmacologic program	* Aged 59 or less * No telephone * Not English speaking * Unwilling to be randomized to either study arm * Not interested in participating in a non-pharmacologic program * Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen * Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam * Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\* (resulting in inability to participate in physical activity intervention) * Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries) * Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)

Inclusion Criteria

Exclusion Criteria

* Aged 60 and older
* English- speaking
* Self-reported MSK pain (include cLBP +/- radiating symptoms, OA, fibromyalgia) on most days for the past 3 months that interferes with daily activities
* Pain intensity that is 4+/10 on the numerical pain rating scale
* Pain interference threshold 5+ on PEG-3
* Depressive symptoms, 10+ on PHQ-9
* Capable of participating in home-based activity
* Interested in participating in a non-pharmacologic program

* Aged 59 or less
* No telephone
* Not English speaking
* Unwilling to be randomized to either study arm
* Not interested in participating in a non-pharmacologic program
* Self-reported uncorrected hearing and visual impairments precluding ability to participate in telephone sessions or read pedometer screen
* Significant (moderate or severe) cognitive impairment (3+ errors) on six-item screening exam
* Self-reported dependence on wheelchair, bed-bound, or severe balance impairment or severe OA\* (resulting in inability to participate in physical activity intervention)
* Illness requiring hospitalization within the last 3 months that interferes with a home-based physical activity intervention (e.g., fall, gout attack, stroke, heart attack, heart failure, surgery for blocked arteries)
* Suicidal intent (see suicide screening protocol), uncontrolled psychotic disorder or psychiatric hospitalization within 1 year, or enrolled in active substance use program (confirmed with scripted protocol over telephone)

Contacts and Locations

Study Contact

Florine Pore-Brown, BS

CONTACT

(214) 857-3291

florine.pore-brown@va.gov

Una E Makris, MD MSc

CONTACT

(214) 857-0409

Una.Makris2@va.gov

Principal Investigator

Una E. Makris, MD MSc

PRINCIPAL_INVESTIGATOR

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Locations (Sites)

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Dallas, Texas, 75216-7167

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Una E. Makris, MD MSc, PRINCIPAL_INVESTIGATOR, VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2023-09-20

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Chronic Back Pain
Depression
Veterans
Aging
Musculoskeletal Pain

Additional Relevant MeSH Terms

Chronic Back Pain
Depression
Aging
Musculoskeletal Pain