PTSDNCT07225049
Integrated PTSD and Chronic Pain Treatment
A study testing Integrated Treatment for PTSD and Chronic Pain in people with PTSD and Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PTSD, Chronic Pain
- What is being tested?
- Integrated Treatment for PTSD and Chronic Pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Mariel Emrich, MS, 212-821-0783, mae2050@med.cornell.edu
JoAnn Difede, PhD
About this study
Official title: 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.
- Conditions
- PTSD, Chronic Pain
- Being tested
- Integrated Treatment for PTSD and Chronic Pain
- Keywords
- PTSD, Chronic Pain, Integrated Treatment, Comorbidity, Prolonged Exposure, CBT for Chronic Pain, Cognitive Behavioral Therapy for Chronic Pain
- Medical subject headings
- Stress Disorders, Post-Traumatic, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Treatment for PTSD and Chronic PainBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated PTSD and Chronic Pain Treatment | Experimental | Integrated treatment combining modules from Prolonged Exposure Therapy with Cognitive Behavioral Therapy for Chronic Pain Receives: Behavioral: Integrated Treatment for PTSD and Chronic Pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Feasibility Indicator: Enrollment
Feasibility assessment will include enrollment defined as number of participants signing the informed consent form.
Measured: Baseline
Feasibility Indicator: Number of Sessions Attended
Feasibility assessment will include the number of sessions attended on average (out of 12).
Measured: 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.
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-Treatment Assessment at approximately 6 weeks
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to approximately 6 weeks
Change in Score on the Religious and Spiritual Struggles Scale (RSS-5)
This is a 5-item questionnaire measuring the extent to which one experiences conflict or struggle with spirituality or religious faith. Each item is rated on a scale from 1 (Not at All) to 5 (A Great Deal), thus higher scores indicate more spiritual struggle.
Measured: Baseline to approximately 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start8 Dec 2025
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JoAnn Difede, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225049
- Sponsor's protocol ID
- 25-01028464
- Status last verified
- Jun 2026
- First submitted
- 27 Oct 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain
- ClinicalTrials.gov ID
- NCT07225049
- Acronym / sponsor ID
- 25-01028464
- Conditions
- PTSD, Chronic Pain
- Keywords
- PTSD, Chronic Pain, Integrated Treatment, Comorbidity, Prolonged Exposure, CBT for Chronic Pain, Cognitive Behavioral Therapy for Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated PTSD and Chronic Pain Treatment | Experimental | Behavioral: Integrated Treatment for PTSD and Chronic PainIntegrated treatment combining modules from Prolonged Exposure Therapy with Cognitive Behavioral Therapy for Chronic Pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Treatment for PTSD and Chronic PainThe 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. | Behavioural | Integrated PTSD and Chronic Pain Treatment |
Primary outcome
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.
17 secondary outcomes
Change in Score on the Clinician Administered PTSD Score (CAPS-5)
Time frame: Baseline to approximately 6 weeks
Change in Score on the PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Pain Catastrophizing Scale (PCS)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Posttraumatic Cognitions Inventory (PTCI)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Fear-Avoidance Components Scale (FACS)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Anxiety Sensitivity Index (ASI-3)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure
Time frame: Baseline to approximately 6 weeks
Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Patient Health Questionnaire (PHQ-9)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Insomnia Severity Index (ISI)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Quality of Life Inventory (QOLI)
Time frame: Baseline to approximately 6 weeks
Change in Score on the Religious and Spiritual Struggles Scale (RSS-5)
Time frame: Baseline to approximately 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JoAnn Difede, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Treatment for PTSD and Chronic Pain in people with PTSD and Chronic Pain, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariel Emrich, MS (212-821-0783, mae2050@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility Indicator: Number of Participants Screened (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.