Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06758414

Exploring the Efficacy of Cognitive Behavioral Therapy for Chronic Pain in Veterans With Serious Mental Illness

Led by VA Office of Research and Development · Updated on 2026-02-09

190

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Chronic musculoskeletal pain greatly impacts Veterans, especially those with serious mental illness (SMI), leading to poorer mental and physical health and hindering recovery. Despite high rates of chronic pain in this group, there is limited research on non-drug pain management strategies. This research evaluates Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), an evidence-based psychotherapy, to understand its effects on pain-related functioning, quality of life, and pain severity in Veterans with SMI and chronic low back pain. Participants will be randomly assigned to either the CBT-CP program or an active control group called Health & Wellness (H&W). CBT-CP involves 12 weekly individual sessions including pain education, goal-setting, and skill-building, with a booster session one month after the last session. The H&W group will receive 10 weekly sessions focused on general physical and emotional wellbeing topics without pain management content. Each session lasts 60 minutes and is led by trained interventionists following a structured manual. Veterans will be assessed at the start, after treatment (approximately 4 months), and at a 6-month follow-up (about 10 months after starting) using tools like the Brief Pain Inventory-Interference, Veterans RAND 36-Item Health Survey, and PEG-3 scale. Additionally, one-week ecological momentary assessments will track daily pain and functioning. Researchers will monitor changes in pain, mental health symptoms, physical activity, and treatment engagement throughout the study, which includes a total participation period of about 10 months.

CONDITIONS

Brief Title

CBT-CP for Veterans With SMI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have chronic back pain, as confirmed by medical records
  • Have a PEG-3 pain severity or interference rating of 4 or greater
  • Have a diagnosis of serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychosis)
  • Be 18 years of age or older
  • Be enrolled in outpatient care at a VISN 5 health care facility at time of consent
  • Have regular access to a telephone
  • Have the ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Currently engage in moderate-to-severe substance use that affects participation or requires higher care
  • Currently receiving or have received individual Cognitive Behavioral Therapy for Chronic Pain within the past 12 months
  • Have an acute pain condition, medical issue, or limited mobility that prevents participation in therapy activities such as walking

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - Approximately 12 weeks

Participants receive weekly individual therapy sessions to manage chronic pain and improve mental health functioning. This includes either Cognitive Behavioral Therapy for Chronic Pain with 12 sessions including a booster session or Health & Wellness psychoeducation with 10 sessions.

Weekly visits for up to 12 weeks

Follow-up

Duration - Approximately 6 months

Participants are evaluated on pain, functioning, and quality of life after treatment ends and again six months later to assess the lasting effects of the therapy.

2 follow-up visits (post-treatment and 6 months post-treatment)

Trial Site Locations

Total: 1 location

1

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States, 21201

Actively Recruiting

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Research Team

L

Letitia Travaglini, PhD

M

Melanie E Bennett

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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