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NCT Number: NCT07225049

Integrated PTSD and Chronic Pain Treatment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

Location status: Recruiting

Location contact

JoAnn Difede, PhD

PRINCIPAL_INVESTIGATOR

Mariel Emrich, MS

CONTACT

[email protected]

212-821-0783

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. Feasibility Indicator: Enrollment

    Time frame: Baseline

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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

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

    Time frame: Baseline to approximately 6 weeks

    Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score. Total Scores range from 0-80. Higher scores indicate greater symptom severity.

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

    Time frame: Baseline to approximately 6 weeks

    The well-validated PCL-5 will assess self-reported PTSD symptom severity. Scores range from 0-80. Higher scores indicate greater symptom severity.

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

    Time frame: Baseline to approximately 6 weeks

    Pain severity is a 4-item subscale with ranges from 0-10. Greater scores indicate higher pain severity.

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

    Time frame: Baseline to approximately 6 weeks

    Pain interference is a 7-item subscale with ranges from 0-10. Greater scores indicate greater pain interference.

  5. Change in Score on the Pain Catastrophizing Scale (PCS)

    Time frame: Baseline to approximately 6 weeks

    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.

  6. Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ)

    Time frame: Baseline to approximately 6 weeks

    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.

  7. Change in Score on the Posttraumatic Cognitions Inventory (PTCI)

    Time frame: Baseline to approximately 6 weeks

    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.

  8. Change in Score on the Fear-Avoidance Components Scale (FACS)

    Time frame: Baseline to approximately 6 weeks

    This 20-item measure results in total scores ranging from 0-100, with greater scores indicating more severe fear-avoidance beliefs.

  9. Change in Score on the Anxiety Sensitivity Index (ASI-3)

    Time frame: Baseline to approximately 6 weeks

    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.

  10. Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

    Time frame: Baseline to approximately 6 weeks

    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.

  11. Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure

    Time frame: Baseline to approximately 6 weeks

    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.

  12. Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18)

    Time frame: Baseline to approximately 6 weeks

    This 18-item measure results in a total score ranging from 18-90 with higher scores reflecting greater difficulties with emotion regulation.

  13. Change in Score on the Patient Health Questionnaire (PHQ-9)

    Time frame: Baseline to approximately 6 weeks

    The PHQ-9 scores range from 0-27. Higher scores indicate greater symptom severity.

  14. Change in Score on the Insomnia Severity Index (ISI)

    Time frame: Baseline to approximately 6 weeks

    7 item self-report measure. Total scores range from 0-28, with higher scores indicating higher insomnia severity.

  15. Change in Score on the Multidimensional Assessment of Interoceptive Awareness (MAIA-2)

    Time frame: Baseline to approximately 6 weeks

    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.

  16. Change in Score on the Quality of Life Inventory (QOLI)

    Time frame: Baseline to approximately 6 weeks

    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.

  17. Change in Score on the Religious and Spiritual Struggles Scale (RSS-5)

    Time frame: Baseline to approximately 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariel Emrich, MS

CONTACT

[email protected]

212-821-0783

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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