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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

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

CPSMI Trial 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.Check my eligibility

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.See study design

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.

CPSMI Trial 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.

CPSMI Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cerebral Palsy

Participant Satisfaction Questionnaire (CSQ-8)

Service Satisfaction Scale (SSS-30)

Secondary outcome measures

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

Pain

World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

+1 more

CPSMI 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

~130

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,139 Total Patients Enrolled

39 Trials studying Chronic Pain

4,712 Patients Enrolled for Chronic Pain

VA Maryland Health Care SystemFED

10 Previous Clinical Trials

691 Total Patients Enrolled

Letitia Travaglini, PhDPrincipal InvestigatorBaltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Media Library

Cognitive Behavioral Therapy for Chronic Pain (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04118283 — N/A

Chronic Pain Research Study Groups: Cognitive Behavioral Therapy for Chronic Pain, Health and Wellness

Chronic Pain Clinical Trial 2023: Cognitive Behavioral Therapy for Chronic Pain Highlights & Side Effects. Trial Name: NCT04118283 — N/A

Cognitive Behavioral Therapy for Chronic Pain (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04118283 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the main focus of this investigation?

"The primary measurement of this medical trial's success is the Cognitive Behavioral Therapy for Chronic pain (CBT-CP) Feasibility, which will be assessed approximately 10 weeks post-intervention. Moreover, secondary objectives include well established psychometric assessments such as the World Health Organization Quality of Life Scale (WHOQOL-BREF), Veterans RAND 36-item Health Survey (VR-36), and World Heath Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)."

Answered by AI

Are there vacancies available for individuals to participate in this clinical research?

"The information hosted on clinicaltrials.gov suggests this medical trial is still recruiting patients, having been initially posted in March 2021 and most recently updated just last month."

Answered by AI

How many volunteers are currently participating in the experiment?

"Affirmative. According to clinicaltrials.gov, this research study is presently seeking applicants, having been initially posted on March 18th 2021 and revised most recently on March 2nd 2022. 45 volunteers are needed at a single facility for the trial's execution."

Answered by AI