Cognitive Behavioral Therapy for Chronic Pain in Veterans with Serious Mental Illness

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.