264 Participants Needed

Behavioral Intervention for Chronic Pain and Depression in Older Veterans

(MOTIVATE_IIR Trial)

Recruiting at 1 trial location
CL
UE
FP
NE
Overseen ByNatalie E Hundt, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since it focuses on a non-drug program, you might be able to continue your medications. It's best to discuss this with the trial coordinators.

What data supports the effectiveness of the treatment Behavioral Intervention Group (MOTIVATE) for chronic pain and depression in older veterans?

Research shows that cognitive behavioral therapy (CBT), a key component of the MOTIVATE treatment, is effective in reducing pain and depression in veterans. Studies have demonstrated significant improvements in pain intensity, depression, and quality of life among veterans receiving CBT for chronic pain.12345

Is the behavioral intervention for chronic pain and depression in older veterans safe?

The studies suggest that behavioral interventions, including those using motivational interviewing and cognitive behavioral therapy, are generally safe and acceptable for individuals with chronic pain and depression. Participants reported positive experiences and no significant safety concerns were noted in the trials.36789

How is the MOTIVATE treatment different from other treatments for chronic pain and depression in older veterans?

The MOTIVATE treatment is unique because it combines behavioral interventions specifically tailored for older veterans with chronic pain and depression, focusing on brief, effective therapy sessions that can be as impactful as longer treatments. This approach is designed to improve pain-related thinking and reduce disability and distress, offering a practical and efficient alternative to more time-intensive therapies.2341011

What is the purpose of this trial?

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.

Research Team

UE

Una E. Makris, MD MSc

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

My pain level is at least 4 out of 10.
I am 60 years old or older.
I have scored 10 or higher on a depression screening test.
See 5 more

Exclusion Criteria

I rely on a wheelchair, am bed-bound, or have severe balance issues or osteoarthritis that prevents me from being active.
I am not interested in non-drug treatments.
I am not willing to be assigned randomly to a treatment group.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MOTIVATE intervention, a remotely delivered behavioral intervention, over 8 sessions via telephone

8 weeks
8 sessions (telephone)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, mid, end, and 6 months

6 months

Waitlist Control

Participants in the waitlist control group continue with usual care and are offered the intervention after completing the end outcomes assessment

3 months

Treatment Details

Interventions

  • Behavioral Intervention Group (MOTIVATE)
Trial Overview 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+

Dallas VA Medical Center

Collaborator

Trials
35
Recruited
4,800+

Michael E. DeBakey VA Medical Center

Collaborator

Trials
68
Recruited
17,200+

Findings from Research

A Brief Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) delivered via VA Video Connect significantly improved various outcomes, including disability, physical health, quality of life, anxiety, and pain levels among Veterans with chronic noncancer pain, regardless of age.
The study indicates that this telehealth approach is effective and accessible for older adults, although some Veterans may be less likely to complete the program, highlighting the need for tailored support to enhance participation.
Examining the Efficacy of a Brief Cognitive-Behavioral Therapy for Chronic Pain (Brief CBT-CP) Group Delivered via VA Video Connect (VVC) Among Older Adult Veterans.Martinson, A., Johanson, K., Wong, S.[2023]
A study evaluating three different lengths of cognitive behavioral therapy (CBT) for chronic pain in Veterans found that all treatment durations (6, 10, and 12 weeks) led to improvements in pain-related thinking, disability, and distress.
Remarkably, the 6-week group showed outcomes that were equivalent or even better than the longer treatment durations, suggesting that shorter CBT interventions can be just as effective for managing chronic pain.
Development and evaluation of a behavioral pain management treatment program in a Veterans Affairs Medical Center.Stratton, KJ., Bender, MC., Cameron, JJ., et al.[2018]
A pilot study involving 64 participants with chronic pain showed that a mobile health intervention combining motivational interviewing and cognitive behavioral therapy increased interest in seeking further depression treatment and willingness to make life changes.
Participants experienced a significant reduction in depression scores after the intervention, indicating that this tailored approach may effectively address depression in patients with chronic pain and warrants further testing in larger trials.
Pilot feasibility study of a brief, tailored mobile health intervention for depression among patients with chronic pain.Ahmedani, BK., Crotty, N., Abdulhak, MM., et al.[2022]

References

Examining the Efficacy of a Brief Cognitive-Behavioral Therapy for Chronic Pain (Brief CBT-CP) Group Delivered via VA Video Connect (VVC) Among Older Adult Veterans. [2023]
Development and evaluation of a behavioral pain management treatment program in a Veterans Affairs Medical Center. [2018]
Pilot feasibility study of a brief, tailored mobile health intervention for depression among patients with chronic pain. [2022]
Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. [2023]
Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain. [2021]
Risk-targeted behavioral activation for the management of work disability associated with comorbid pain and depression: a feasibility study. [2022]
Preliminary Outcomes of an Older Peer and Clinician co-Facilitated Pain Rehabilitation Intervention among Adults Aged 50 Years and Older with Comorbid Chronic Pain and Mental Health Conditions. [2022]
The association of persistent pain with out-patient addiction treatment outcomes and service utilization. [2018]
A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548]. [2021]
Problem Adaptation Therapy for Pain (PATH-Pain): A Psychosocial Intervention for Older Adults with Chronic Pain and Negative Emotions in Primary Care. [2023]
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