NCT07225049 Integrated PTSD and Chronic Pain Treatment
| NCT ID | NCT07225049 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | PTSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-08 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
JoAnn Difede, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT07225049 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07225049 currently recruiting?
Yes, NCT07225049 is actively recruiting participants. Contact the research team at mae2050@med.cornell.edu for enrollment information.
Where is the NCT07225049 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07225049 clinical trial?
NCT07225049 is sponsored by Weill Medical College of Cornell University. The principal investigator is JoAnn Difede, PhD at Weill Medical College of Cornell University. The trial plans to enroll 20 participants.
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