Recruiting

Integrated Treatment

Sponsor:

Weill Medical College of Cornell University

Code:

NCT07225049

Conditions

PTSD

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Integrated Treatment for PTSD and Chronic Pain

Study Details

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 ID

NCT07225049

Start date

Dec 8, 2025

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • Must be located in the state of New York for virtual assessments and treatment sessions

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Integrated PTSD and Chronic Pain Treatment

Integrated treatment combining modules from Prolonged Exposure Therapy with 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.

Primary outcome measure

  • Feasibility Indicator: Number of Participants Screened [ Time Frame: Baseline ]
  • Feasibility Indicator: Enrollment [ Time Frame: Baseline ]
  • Feasibility Indicator: Number of Sessions Attended [ Time Frame: Post-Treatment Assessment at approximately 6 weeks ]
  • Feasibility Indicator: Attrition Percentage [ Time Frame: Post-Treatment Assessment at approximately 6 weeks ]
  • Feasibility Indicator: Number of Assessments Attended [ Time Frame: Baseline and Post-Treatment Assessment at approximately 6 weeks ]
  • Feasibility Indicator: Percentage of Self-Reports Completed [ Time Frame: Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks) ]
  • Intervention Satisfaction [ Time Frame: Post-Treatment Assessment at approximately 6 weeks ]
  • Intervention Acceptability [ Time Frame: Post-Treatment Assessment at approximately 6 weeks ]
  • Qualitative Intervention Feedback [ Time Frame: Post-Treatment Assessment at approximately 6 weeks ]

Central Contacts and Locations

Central contacts

Mariel Emrich, MS

212-821-0783mae2050@med.cornell.edu

Locations

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

Mariel Emrich, MS

212-821-0783mae2050@med.cornell.edu

Principal Investigator:

JoAnn Difede, PhD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • PTSD
  • Chronic Pain
  • Integrated Treatment
  • Comorbidity
  • Prolonged Exposure
  • CBT for Chronic Pain
  • Cognitive Behavioral Therapy for Chronic Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.