Integrated PTSD and Chronic Pain Treatment

NCT ID: NCT07225049

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-08
• Study Completion Date: 2027-08-31

Brief Summary

Posttraumatic stress disorder (PTSD) occurs in approximately 7% of adults in the general population. PTSD greatly impacts quality of life and often co-occurs with other conditions such as chronic pain. Individuals with co-morbid PTSD and chronic pain demonstrate higher PTSD symptoms and pain (as well as greater anxiety, depression, disability, and opioid use) compared to those with only one of those conditions. Gold standard treatments exist for both PTSD (e.g., Prolonged Exposure; PE) and chronic pain (e.g., Cognitive Behavioral Therapy for Chronic Pain; CBT-CP) and are generally offered sequentially (i.e., one at a time for the condition that is most prominent). Treating these conditions separately may overlook their interconnected nature, which may reduce efficacy and increase dropout. Thus, there is a need for an intervention to target both simultaneously, which may be more effective and efficient than treating conditions sequentially.

This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and chronic pain. The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment draws from modules in PE and CBT-CP including psychoeducation, exposure to feared/avoided situations and activities, processing of exposures, behavioral activation, breathing and relaxation techniques, sleep hygiene, symptom monitoring, and structured homework assignments. Baseline and post-treatment assessments will be conducted.

Conditions

PTSD; Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Integrated PTSD and Chronic Pain Treatment

Integrated treatment combining modules from Prolonged Exposure Therapy with Cognitive Behavioral Therapy for Chronic Pain

Group Type: EXPERIMENTAL

Integrated Treatment for PTSD and Chronic Pain

Intervention Type: BEHAVIORAL

The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment integrates modules from Prolonged Exposure and Cognitive Behavioral Therapy for Chronic Pain.

Interventions

Integrated Treatment for PTSD and Chronic Pain

The intervention consists of 12 90-minute virtual psychotherapy sessions scheduled twice per week. The treatment integrates modules from Prolonged Exposure and Cognitive Behavioral Therapy for Chronic Pain.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• English-speaking
• Currently meets criteria for PTSD, assessed by the CAPS-5 (any trauma type) - Chronic pain, assessed by greater than or equal to 4 on a scale of 0-10 pain severity over the past 3 months
• Medically stable at the time of study enrollment (chronic illness and disability does not prevent attendance of outpatient therapy sessions)
• Stable on psychotropic medication for past 60 days
• Agreed to not change current medication or pain-related treatments over the course of the study unless medically necessary

Exclusion Criteria

• Lifetime diagnosis of schizophrenia, other psychotic disorder, or bipolar I disorder
• Participation in concurrent evidence-based psychological treatment for PTSD or chronic pain during the past 3 months
• Participants must not participate in an evidence-based psychological treatment for either PTSD or pain during the course of the study.
• Moderate or severe substance use in the past 90 days
• Cognitive impairment to the degree that the patient cannot provide informed consent or fill out assessment measures
• Participants who in the PI's judgement pose a current homicidal or suicidal risk

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JoAnn Difede, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariel Emrich, MS

Role: CONTACT

mae2050@med.cornell.edu

212-821-0783

Facility Contacts

Mariel Emrich, MS

Role: primary

mae2050@med.cornell.edu

212-821-0783

Other Identifiers

25-01028464

Identifier Type: -

Identifier Source: org_study_id