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Behavioral Intervention for Chronic Pain and Depression in Older Veterans (MOTIVATE_IIR Trial)

N/A

Recruiting

Led By Una E. Makris, MD MSc

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain intensity that is 4+/10 on the numerical pain rating scale

Aged 60 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, mid (~5 weeks), end (~3 months) and 6 months

Awards & highlights

MOTIVATE_IIR Trial Summary

This trial will test a new pain management program for older Veterans with both chronic pain and depression.

Who is the study for?

This trial is for older Veterans aged 60+ who speak English, have chronic musculoskeletal pain and depressive symptoms. They must be able to do home-based activities, score 10+ on the PHQ-9 depression scale, experience pain most days with an intensity of 4+/10 and interference level of 5+ on PEG-3. Exclusions include severe cognitive impairment, recent hospitalization that affects physical activity, suicidal intent or uncontrolled psychotic disorders.Check my eligibility

What is being tested?

The MOTIVATE program is being tested in this study. It's a behavioral intervention aimed at improving outcomes for older veterans dealing with both musculoskeletal pain and depression by using non-pharmacologic methods tailored to be done at home.See study design

What are the potential side effects?

Since MOTIVATE is a behavioral intervention involving non-drug approaches like exercise and mental health strategies rather than medication, it may not have typical 'side effects.' Participants might experience discomfort from new activities or emotional distress during therapy sessions.

MOTIVATE_IIR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain level is at least 4 out of 10.

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I am 60 years old or older.

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I have scored 10 or higher on a depression screening test.

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I have had muscle or joint pain almost daily for the past 3 months that affects my daily activities.

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My pain often interferes with my daily activities.

MOTIVATE_IIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, mid (~5 weeks), end (~3 months) and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, mid (~5 weeks), end (~3 months) and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, mid (~5 weeks), end (~3 months) and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

: Pain interference

Secondary outcome measures

Anxiety

Arthritis self-efficacy

Depressive symptoms, PHQ-9

+10 more

MOTIVATE_IIR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavior Intervention Group (MOTIVATE)Experimental Treatment1 Intervention

For participants assigned to the intervention arm, trained health coaches will deliver the 8 session intervention via telephone. MOTIVATE users motivational interviewing techniques, values elicitation and physical activity based goal setting. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant.

Group II: Waitlist Control GroupActive Control1 Intervention

The waitlist control group will continue with usual care management of musculoskeletal pain and depression. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, midpoint, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the intervention once they have completed the end outcomes assessment.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,339 Total Patients Enrolled

23 Trials studying Aging

2,555 Patients Enrolled for Aging

Dallas VA Medical CenterFED

34 Previous Clinical Trials

4,571 Total Patients Enrolled

1 Trials studying Aging

50 Patients Enrolled for Aging

Michael E. DeBakey VA Medical CenterFED

64 Previous Clinical Trials

15,524 Total Patients Enrolled

3 Trials studying Aging

334 Patients Enrolled for Aging

Media Library

Behavioral Intervention Group (MOTIVATE) Clinical Trial Eligibility Overview. Trial Name: NCT05220202 — N/A

Aging Research Study Groups: Behavior Intervention Group (MOTIVATE), Waitlist Control Group

Aging Clinical Trial 2023: Behavioral Intervention Group (MOTIVATE) Highlights & Side Effects. Trial Name: NCT05220202 — N/A

Behavioral Intervention Group (MOTIVATE) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220202 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being considered as potential participants in this research project?

"According to the trial's prerequisites, those who wish to take part must be between 60 and 99 years of age."

Answered by AI

Could you elucidate if this clinical trial is currently accepting participants?

"Unfortunately, clinicaltrials.gov states that this trial is not open to new participants as of now. This study was initially posted on February 1st 2023 and last edited August 5th 2022; though there are 1855 other trials currently recruiting patients at present."

Answered by AI