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CBT-CP for Veterans with Serious Mental Illness and Chronic Pain

This study is looking at how well Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) works for Veterans who have both chronic back pain and a serious mental illness (SMI), such as schizophrenia or bipolar disorder. CBT-CP is a type of talk therapy that helps you manage pain. The study will compare CBT-CP to a Health & Wellness program, which teaches about physical and emotional well-being. Researchers want to see if these therapies can help Veterans with their pain, daily activities, and overall quality of life. To join, you must be at least 18 years old, have chronic back pain, and have an SMI diagnosis. The study aims to enroll 190 Veterans.

Study design
This is a randomized controlled trial comparing two behavioral therapies, CBT-CP and Health & Wellness, with 190 participants.
What's involved
Participants will have 10 weekly individual 60-minute sessions for their assigned therapy. Pain and health surveys will be completed at the end of treatment and 6 months later.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about 6 months after their treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06758414

CBT-CP for Veterans With SMI

Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~190 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)Health & Wellness (H&W)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Brief Pain Inventory-Interference (BPI-INT)
Measured over post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)
+2 more outcomes measured

Conditions

Chronic Pain
Schizophrenia
Psychotic Disorders
Bipolar Disorder
Affective Disorders, Psychotic

Explore related trials

Bipolar DisorderChronic back painSchizoaffective DisorderSchizophreniaUnipolar Depression

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Letitia Travaglini, PhD · PRINCIPAL_INVESTIGATOR · Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Who to contact

Letitia Travaglini, PhD
[email protected]
(410) 605-1867
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Brief Pain Inventory-Interference (BPI-INT)post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)

    The Brief pain Inventory - Interference subscale (BPI-INT) is a 9-item questionnaire measuring pain-relate interference. Respondents answer the degree to which pain interferes with mood/affect and physical activity on a scale from 0 (not at all) to 10 (all the time/completely). An average score is calculated, with a score of \>= 4 indicating moderate to severe pain interference. The instrument has excellent psychometric properties and is regularly used in pain research and clinical practice.

  • Veterans RAND 36-Item Health Survey (VR-36)post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)

    The Veterans RAND 36-Item Health Survey (VR-36) is a 36-item questionnaire measuring health-related quality of life and 8 domains of health-related functioning (physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, general health perceptions, vitality, social functioning, and mental health). Items are scored on a 3- to 6-point scale and are summed to create a total and domain scores, ranging from 0 (worst health status) to 100 (best health status). The VR-36 demonstrated improved reliability, precision, and validity compared to the SF-36 and among persons with SMI.

  • PEG-3post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)

    The PEG-3 will assess pain severity and related functioning and quality of life (enjoyment, general activity), using a 0 to 10 rating scale with qualifying statements for each numeric rating; a rating of 4 or greater indicates moderate-to-severe pain intensity. The PEG-3 will be included in the Ecological Momentary Assessment (EMA) surveys; Veterans will be asked about the extent to which they have experienced each item in the one hour prior to survey completion. The PEG-3 has been validated in Veterans receiving VA primary care services and has good reliability and validity when compared to longer pain assessments. As a primary outcome, changes in the two items assessing functioning (General activity interference) and quality of life (Enjoyment of life) will be examined.