Behavioral Intervention for Chronic Pain and Depression in Older Veterans

(MOTIVATE_IIR Trial)

Recruiting at 1 trial location

Overseen By Natalie E Hundt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Wheelchair dependence, Hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called MOTIVATE, designed to help older veterans manage chronic musculoskeletal pain and depression. The study will test whether this behavioral program, involving phone sessions with health coaches, can improve daily life by setting goals and encouraging physical activity. To evaluate its effectiveness, participants will either receive the MOTIVATE program or continue with their usual care. Veterans experiencing daily pain that interferes with activities and showing signs of depression might be suitable candidates.

As an unphased trial, this study provides veterans with a unique opportunity to contribute to research that could enhance their quality of life.

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 prior data suggests that this behavioral intervention is safe for older veterans with chronic pain and depression?

A previous study showed that programs like MOTIVATE, which focus on changing behavior, hold promise for managing chronic pain and depression. Research suggests that participants generally find these programs easy to handle. Many report feeling better with few side effects.

Although specific safety data for MOTIVATE is unavailable, these programs do not involve surgery or medication, reducing risk. Participants typically engage in activities such as goal-setting and motivational conversations, which are safe.

In summary, MOTIVATE is expected to be a safe option for those dealing with chronic pain and depression, with no major negative effects reported in similar studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Behavioral Intervention for Chronic Pain and Depression in older veterans because it takes a fresh approach by focusing on motivational interviewing, values elicitation, and goal-setting for physical activity. Unlike standard treatments that often rely on medication or therapy sessions, this intervention is delivered conveniently over the phone by trained health coaches, making it accessible and easy for participants to engage with from their own homes. This method emphasizes empowering patients to set and achieve personalized goals, potentially leading to more sustainable improvements in their well-being.

What evidence suggests that this behavioral intervention is effective for chronic pain and depression?

Research has shown that programs like MOTIVATE, which participants in this trial may receive, can help reduce long-term pain and depression. For older adults, these programs often involve discussing motivation and setting goals for physical activity. Participants in these programs have reported better pain management and improved emotional health. Studies on similar programs, such as Cognitive Behavioral Therapy (CBT), have also demonstrated positive results in reducing pain and enhancing mental health in veterans. This suggests that MOTIVATE could benefit older veterans dealing with chronic pain and depression. ^{6 7 8 9 10}

Who Is on the Research Team?

Una E. Makris, MD MSc

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Behavior Intervention Group (MOTIVATE) Experimental Treatment 1 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 Group Active Control 1 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.

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+

Published Research Related to This Trial

A 10-week behavioral activation intervention for 66 work-disabled individuals with pain and depression led to significant reductions in depression (Cohen's d = 0.86), catastrophic thinking (d = 1.1), and perceived injustice (d = 1.0), indicating its effectiveness.

The intervention was well-received, with 91% of participants satisfied, and improvements in psychosocial factors were linked to better return-to-work outcomes, suggesting that addressing these factors can enhance recovery for individuals with comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk-targeted behavioral activation for the management of work disability associated with comorbid pain and depression: a feasibility study. Sullivan, MJL., Wideman, TH., Gauthier, N., et al.[2022]

The VA's cognitive behavioral therapy for chronic pain (CBT-CP) has shown significant effectiveness in improving various patient outcomes, including pain intensity and quality of life, based on a review of 1,331 Veterans treated from 2012 to 2018.

Patients experienced large reductions in pain catastrophizing (Cohen's d = 0.78) and medium to large improvements in other areas such as depression and physical quality of life, indicating that CBT-CP is a safe and effective nonpharmacological treatment for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic pain in veterans: Evidence for clinical effectiveness in a model program. Murphy, JL., Cordova, MJ., Dedert, EA.[2023]

A randomized controlled trial involving 256 older adults (average age 81.8) found that pain self-management training did not significantly improve physical disability or other outcomes compared to an education-only control group.

However, participants in the self-management group reported greater increases in relaxation and exercise/stretching techniques, suggesting that while overall effectiveness was not established, the training may enhance coping strategies for managing chronic pain.

NCBI (Pubmed)

pubmed.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]. Ersek, M., Turner, JA., Cain, KC., et al.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Behavioral Activation for Pain Rehabilitation (BA-PR) intervention showed promise in reducing the risk of prescription opioid misuse among older adults with chronic pain and mental health conditions, with a significant reduction observed in a small sample of eight participants.

Participants reported positive experiences with the BA-PR intervention, achieving high adherence rates (100%) and a retention rate of 75%, suggesting that this intervention is both acceptable and feasible for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Brooks, JM., Umucu, E., Storm, M., et al.[2022]

A 12-week study involving 40 veterans with chronic pain tested a financial incentive strategy, called a 'regret lottery', to increase physical activity, but found no significant differences in activity levels or related outcomes between the intervention and control groups.

The results suggest that regret lottery-based incentives may not be effective in promoting physical activity among veterans with chronic pain, indicating a need for alternative strategies to address this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to evaluate a behavioral economic strategy for improving mobility in veterans with chronic pain. Compton, P., Chaiyachati, KH., Dicks, T., et al.[2022]

A randomized controlled trial involving 83 participants from a low-socioeconomic status rural chronic pain population found that both cognitive behavioral therapy (CBT) and group education (EDU) led to significant improvements in pain-related outcomes, with CBT showing greater gains in cognitive and affective variables.

Despite a higher dropout rate in the CBT group, the treatment effects were maintained at a 6-month follow-up, suggesting that both CBT and EDU are effective and acceptable options for managing chronic pain in underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of group cognitive behavioral therapy compared with a pain education control for low-literacy rural people with chronic pain. Thorn, BE., Day, MA., Burns, J., et al.[2021]

Problem Adaptation Therapy for Pain in Primary Care (PATH-Pain) is a new psychosocial intervention designed specifically for older adults with chronic pain and cognitive impairments, addressing the gap in treatment options for this population.

The therapy aims to help older adults manage negative emotions associated with chronic pain, potentially improving their quality of life and social functioning, which is crucial given the high prevalence of chronic pain in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem Adaptation Therapy for Pain (PATH-Pain): A Psychosocial Intervention for Older Adults with Chronic Pain and Negative Emotions in Primary Care. Kiosses, DN., Ravdin, LD., Stern, A., et al.[2023]

Approximately 33.2% of veterans in outpatient addiction treatment experience persistent pain, which negatively impacts their treatment outcomes, including lower rates of abstinence from alcohol and drugs.

Veterans with persistent pain were in treatment for significantly fewer days and had higher medical service utilization and costs compared to those with low pain, indicating a need for integrated pain management in addiction treatment programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of persistent pain with out-patient addiction treatment outcomes and service utilization. Caldeiro, RM., Malte, CA., Calsyn, DA., 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05220202

MOTIVATE to Improve Outcomes for Older Veterans With ...

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

2.

withpower.com

withpower.com/trial/phase-back-pain-7-2022-32a58?condition=aging&hasNoPlacebo=false&overallStatus=Recruiting

Behavioral Intervention for Chronic Pain and Depression in ...

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

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38869899/

Emotional Awareness and Expression Therapy vs Cognitive ...

Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial.

4.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2819961

Emotional Awareness and Expression Therapy vs CBT for ...

These findings support the superiority of EAET compared with CBT in reducing chronic pain among older veterans.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10009772/

Cognitive Behavioral Therapy for Chronic Pain in Veterans

Given that, this paper focuses on effectiveness in Veteran outcomes for subsequent cohorts of the CBT-CP training program between 2012 and 2018.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6919581/

Effectiveness of integrative medicine group visits in chronic ...

Data collected at baseline, 9, and 21 weeks included primary outcomes depressive symptoms (Patient Health Questionnaire 9), pain (Brief Pain Inventory).

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9411762/

Examining the association between group context effects and ...

The aim of this study was to investigate associations between group composition variables at the start of treatment and individual outcomes

8.

rti.org

rti.org/impact/inspire-trial-managing-long-term-pain

INSPIRE Trial: Chronic Pain Management Comparison

A large pragmatic, randomized trial to test two behavioral interventions for people experiencing chronic pain on voluntary opioid reduction.

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03265210?term=AREA%5BBasicSearch%5D(older%20men's%20sleep%20study)&rank=1

A Behavioral Intervention for Depression and Chronic Pain in ...

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

10.

sciencedirect.com

sciencedirect.com/science/article/pii/S1526590023006119

The Effectiveness of Interventions for Improving Chronic ...

This systematic review presents current evidence evaluating interventions for CP-related and MH outcomes for people with comorbid CP and clinically diagnosed ...