Integrated PTSD and Chronic Pain Treatment

NCT07225049 | Recruiting

• 1 other identifier: 25-01028464
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Feasibility Indicator: Number of Participants Screened

  Feasibility assessment will include number of participants screened defined as number of individuals who complete our initial eligibility screener.

  Baseline

• Feasibility Indicator: Enrollment

  Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.

  Baseline

• Feasibility Indicator: Number of Sessions Attended

  Feasibility assessment will include the number of sessions attended on average (out of 12).

  Post-Treatment Assessment at approximately 6 weeks

• Feasibility Indicator: Attrition Percentage

  A feasibility measure of attrition will be assessed by examining the percent of individuals who did not complete all 12 intervention sessions.

  Post-Treatment Assessment at approximately 6 weeks

• Feasibility Indicator: Number of Assessments Attended

  A feasibility indicator of number of assessments (baseline and post-treatment) attended will be measured.

  Baseline and Post-Treatment Assessment at approximately 6 weeks

• Feasibility Indicator: Percentage of Self-Reports Completed

  Self-reports are administered at each assessment (baseline and post-intervention) as well as every other treatment session (every 2 weeks up to 12 weeks). Therefore, there are 8 total self-report assessments and the percentage of those completed will be calculated.

  Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks)

• Intervention Satisfaction

  Intervention satisfaction will be rated with a Likert scale ranging from 1-10 with greater scores indicating higher satisfaction.

  Post-Treatment Assessment at approximately 6 weeks

• Intervention Acceptability

  Intervention acceptability will be measured on a Likert scale ranging from 1-10 with greater scores indicating higher acceptability.

  Post-Treatment Assessment at approximately 6 weeks

• Qualitative Intervention Feedback

  Open-ended questions that include assessing overall impressions of treatment, feedback on the frequency and length of sessions, challenges or barriers, likelihood of recommending this treatment to a friend, and comparison of this treatment to other treatments received in the past.

  Post-Treatment Assessment at approximately 6 weeks

Secondary Outcomes (16)

• Change in Score on the Clinician Administered PTSD Score (CAPS-5)

  Baseline to approximately 6 weeks

• Change in Score on the PTSD Checklist for DSM-5 (PCL-5)

  Baseline to approximately 6 weeks

• Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI)

  Baseline to approximately 6 weeks

• Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI)

  Baseline to approximately 6 weeks

• Change in Score on the Pain Catastrophizing Scale (PCS)

  Baseline to approximately 6 weeks

Study Arms (1)

Integrated PTSD and Chronic Pain Treatment

EXPERIMENTAL

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

Behavioral: Integrated Treatment for PTSD and Chronic Pain

Interventions

Integrated Treatment for PTSD and Chronic Pain 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.

Integrated PTSD and Chronic Pain Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Chronic Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• JoAnn Difede, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariel Emrich, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2025
• First Posted: November 5, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)