NCT07225049 · Weill Medical College of Cornell University
Integrated PTSD and Chronic Pain Treatment
What this study is about
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.
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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.
Interventions
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.
Primary outcome measures
Feasibility Indicator: Number of Participants Screened
Time frame: Baseline
Feasibility assessment will include number of participants screened defined as number of individuals who complete our initial eligibility screener.
Feasibility Indicator: Enrollment
Time frame: Baseline
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Feasibility Indicator: Number of Sessions Attended
Time frame: Post-Treatment Assessment at approximately 6 weeks
Feasibility assessment will include the number of sessions attended on average (out of 12).
Feasibility Indicator: Attrition Percentage
Time frame: Post-Treatment Assessment at approximately 6 weeks
A feasibility measure of attrition will be assessed by examining the percent of individuals who did not complete all 12 intervention sessions.
Feasibility Indicator: Number of Assessments Attended
Time frame: Baseline and Post-Treatment Assessment at approximately 6 weeks
A feasibility indicator of number of assessments (baseline and post-treatment) attended will be measured.
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)
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.
Intervention Satisfaction
Time frame: Post-Treatment Assessment at approximately 6 weeks
Intervention satisfaction will be rated with a Likert scale ranging from 1-10 with greater scores indicating higher satisfaction.
Intervention Acceptability
Time frame: Post-Treatment Assessment at approximately 6 weeks
Intervention acceptability will be measured on a Likert scale ranging from 1-10 with greater scores indicating higher acceptability.
Qualitative Intervention Feedback
Time frame: Post-Treatment Assessment at approximately 6 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations