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Behavioral Intervention

Cognitive Behavioral Therapy for Serious Mental Illness-related Chronic Pain (CPSMI Trial)

N/A

Recruiting

Led By Letitia Travaglini, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder) per medical record

18 years of age or older

Must not have

Have a current acute pain 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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a therapy called CBT-CP, which is used to help manage chronic pain, is feasible and acceptable to Veterans with SMI, and if it is worth examining in a larger clinical trial.

Who is the study for?

This trial is for Veterans with serious mental illnesses like schizophrenia or bipolar disorder who also suffer from chronic pain. Participants must be adults enrolled in VA Maryland Health Care System outpatient programs, able to give informed consent, and have a certain level of pain severity. Those with severe substance use issues or current acute pain conditions that would hinder participation are excluded.

What is being tested?

The study tests the suitability and effectiveness of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) among Veterans with serious mental illness. It aims to improve nonpharmacological management of chronic pain and understand its relationship with psychiatric symptoms.

What are the potential side effects?

Since CBT-CP is a form of therapy rather than medication, it may not have typical 'side effects,' but participants might experience emotional discomfort when discussing painful experiences or implementing new coping strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My medical records show a diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder.

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I am 18 years old or older.

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I have been diagnosed with long-term muscle or joint pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot walk a city block due to pain or limited mobility.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cerebral Palsy

Participant Satisfaction Questionnaire (CSQ-8)

Service Satisfaction Scale (SSS-30)

Secondary study objectives

Veterans RAND 36-item Health Survey (VR-36)

Pain

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioral Therapy for Chronic PainExperimental Treatment1 Intervention

Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan.

Group II: Health and WellnessActive Control1 Intervention

Health \& Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Behavioral Therapy for Chronic Pain

2019

N/A

~350

0 / 4Eligibility criteria met