Integrated PTSD and Chronic Pain Treatment

Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: PTSD; Chronic Pain
• Intervention / Treatment: Behavioral: Integrated Treatment for PTSD and Chronic Pain

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariel Emrich, MS; Phone Number: 212-821-0783; Email: mae2050@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Principal Investigator: JoAnn Difede, PhD
      • Contact: Mariel Emrich, MS; Phone Number: 212-821-0783; Email: mae2050@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated PTSD and Chronic Pain Treatment; Integrated treatment combining modules from Prolonged Exposure Therapy with Cognitive Behavioral Therapy for Chronic Pain	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility Indicator: Enrollment	Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.	Baseline
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: 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Score on the Clinician Administered PTSD Score (CAPS-5)	Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.	Baseline to approximately 6 weeks
Change in Score on the PTSD Checklist for DSM-5 (PCL-5)	The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.	Baseline to approximately 6 weeks
Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI)	Pain severity is a 4-item subscale with ranges from 0-10. Greater scores indicate higher pain severity.	Baseline to approximately 6 weeks
Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI)	Pain interference is a 7-item subscale with ranges from 0-10. Greater scores indicate greater pain interference.	Baseline to approximately 6 weeks
Change in Score on the Pain Catastrophizing Scale (PCS)	The 13-item PCS measure has scores ranging from 0-52, with higher scores indicating greater pain catastrophizing. Three subscales (rumination, magnification, and helplessness) are summed to form the total score.	Baseline to approximately 6 weeks
Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ)	This 20-item measure results in a total score ranging from 0-120 with high scores reflecting greater acceptance of pain. Two subscales (activity engagement and pain willingness) are summed to create the total score.	Baseline to approximately 6 weeks
Change in Score on the Posttraumatic Cognitions Inventory (PTCI)	The 33-item PTCI yields three subscores: negative cognitions about the self, negative cognitions about the world, and self-blame. Items are averaged so the range of scores for each subscale is 0-7 with higher scores representing more maladaptive cognitions. A total score is calculated by summing each of the 33 items yielding a score between 33-231, with higher scores indicating more maladaptive cognitions.	Baseline to approximately 6 weeks
Change in Score on the Fear-Avoidance Components Scale (FACS)	This 20-item measure results in total scores ranging from 0-100, with greater scores indicating more severe fear-avoidance beliefs.	Baseline to approximately 6 weeks
Change in Score on the Anxiety Sensitivity Index (ASI-3)	This 18-item measure results in a total score ranging from 0-72 with higher scores reflecting greater anxiety sensitivity. Three subscales (physical concerns, cognitive concerns, and social concerns) are summed to create a total score.	Baseline to approximately 6 weeks
Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)	The ASSIST is a questionnaire that screens for all levels of problem or risky substance use in adults including tobacco, alcohol, cannabis, cocaine, amphetamine-type stimulants, inhalants, sedatives, hallucinogens, opioids, and other drugs. A score for each substance ranges from 0-39 with higher scores indicating greater problems or risks related to substance use. A total score is not computed and instead, each substance will be analyzed individually.	Baseline to approximately 6 weeks
Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure	The EAA is a 5-item scale. Items are summed to generate a total score ranging from 0-45 with higher scores indicating greater expectancy for alcohol analgesia.	Baseline to approximately 6 weeks
Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18)	This 18-item measure results in a total score ranging from 18-90 with higher scores reflecting greater difficulties with emotion regulation.	Baseline to approximately 6 weeks
Change in Score on the Patient Health Questionnaire (PHQ-9)	The PHQ-9 scores range from 0-27. Higher scores indicate greater symptom severity.	Baseline to approximately 6 weeks
Change in Score on the Insomnia Severity Index (ISI)	7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.	Baseline to approximately 6 weeks
Change in Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA-2)	This is a 37-item measure that results in 8 subscales: noticing, not-distracting, not-worrying, attention regulation, emotional awareness, self-regulation, body listening, and trust. Each subscale ranges from 0-5, where higher scores reflect more awareness of bodily sensations. A total score is not computed, and instead, each subscale is analyzed individually.	Baseline to approximately 6 weeks
Change in Score on the Quality of Life Inventory (QOLI)	The assessment yields an overall score and profile in 16 areas of life; health, self-esteem, goals and values, money, work, play, learning, creativity, helping, love, friends, children, relatives, home, neighborhood, and community. Subscales are computed by multiplying satisfaction (-3 to +3) by importance (0 to 2) and resulting scores are averaged to yield a total score ranging from -6 to +6, with higher scores indicate higher level of quality of life.	Baseline to approximately 6 weeks

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: JoAnn Difede, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: October 27, 2025
• First Submitted That Met QC Criteria: November 4, 2025
• First Posted (Estimated): November 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: PTSD; Chronic Pain; Comorbidity; Prolonged Exposure; Integrated Treatment; Cognitive Behavioral Therapy for Chronic Pain; CBT for Chronic Pain
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Stress Disorders, Traumatic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 25-01028464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No