Cognitive Behavioral Therapy for Chronic Pain in Veterans with Serious Mental Illness
Exploring the Efficacy of Cognitive Behavioral Therapy for Chronic Pain in Veterans With Serious Mental Illness
This study will test whether Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) helps Veterans with serious mental illness and chronic low back pain reduce pain-related interference and improve quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06758414 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial will enroll about 190 Veterans with serious mental illness (schizophrenia, schizoaffective disorder, bipolar disorder, or major depression with psychosis) and chronic low back musculoskeletal pain and randomize them to CBT-CP or an active Health & Wellness control. Treatments are delivered within the VA setting and outcomes are measured at baseline, immediately post-treatment, and six months post-treatment using standardized assessments of pain-related functioning, pain severity, and quality of life. The study will also examine how changes in pain relate to psychiatric symptoms over time. Participants must meet a PEG-3 threshold and be enrolled in outpatient programming within VISN 5.
Who should consider this trial
Good fit: Veterans aged 18 or older who are enrolled in outpatient programming at a VISN 5 VA facility, have a documented SMI diagnosis and chronic low back musculoskeletal pain with a PEG-3 score of 4 or higher, have regular telephone access, and have capacity to consent are the intended participants.
Not a fit: Patients actively using moderate-to-severe substances, those who have received individual CBT-CP within the past 12 months, or those with acute pain conditions or limited mobility that prevent participation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, CBT-CP could offer a non-drug treatment that reduces pain interference and improves functioning and quality of life for Veterans with serious mental illness.
How similar studies have performed: CBT-CP is an established, evidence-based nonpharmacological treatment for chronic pain in general and in VA populations, but few randomized trials have tested its effectiveness specifically in people with serious mental illness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have chronic back pain, per medical record * Have a PEG-3 rating of 4 or greater for pain severity or interference * Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder, major depression with psychosis) per medical record * 18 years of age or older * Enrolled in outpatient programming within a VISN 5 health care facility at time of consent * Have regular access to a telephone * Capacity to sign informed consent Exclusion Criteria: * Are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by treating provider) * Engagement in individual Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past 12 months * Have a current acute pain condition, medical condition, or limited mobility (i.e., unable to walk one city block) that would interfere with their ability to engage in CBT-CP interventions (e.g., activity pacing/walking program)
Where this trial is running
Baltimore, Maryland
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Letitia Travaglini, PhD — Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
- Study coordinator: Letitia Travaglini, PhD
- Email: Letitia.Travaglini@va.gov
- Phone: (410) 605-1867
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.