Integrated Treatment for PTSD and Chronic Pain

Overseen By Mariel Emrich, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Schizophrenia, Bipolar I, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for individuals experiencing both PTSD and chronic pain simultaneously. The goal is to determine if addressing these issues together, rather than sequentially, improves symptoms more effectively. Participants will engage in virtual therapy sessions incorporating techniques from established therapies for PTSD and chronic pain, such as managing exposure to feared situations and learning relaxation methods. The study seeks English-speaking adults who currently experience both PTSD and chronic pain that impacts daily life. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could lead to more effective treatments for these challenging conditions.

Will I have to stop taking my current medications?

No, you won't have to stop taking your current medications, but you need to stay on the same medication and pain-related treatments throughout the study unless it's medically necessary to change.

What prior data suggests that this integrated treatment is safe for PTSD and chronic pain?

Research shows that combining Prolonged Exposure (PE) Therapy and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) offers a promising way to treat PTSD and chronic pain together. Previous studies have found these therapies safe when used individually. PE has been proven to significantly reduce PTSD symptoms, and CBT-CP is well-accepted for managing chronic pain.

In another study, a treatment that combined elements of these therapies showed positive results in veterans with similar issues. Participants reported fewer symptoms and no major safety problems, suggesting that the combined approach is generally well-tolerated.

While researchers continue to study this specific combined treatment, the individual components have a strong safety record. Participants typically handle the therapies well, making this an encouraging option for those dealing with both PTSD and chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the integrated treatment for PTSD and chronic pain because it combines two powerful therapy approaches into one cohesive treatment. While traditional treatments often tackle PTSD and chronic pain separately—using Prolonged Exposure Therapy for PTSD and Cognitive Behavioral Therapy for chronic pain—this new approach blends elements of both. This integration could potentially enhance treatment effectiveness by addressing the interconnectedness of PTSD and chronic pain, offering a more comprehensive solution for individuals suffering from both conditions.

What evidence suggests that this integrated treatment is effective for PTSD and chronic pain?

Research has shown that both Prolonged Exposure Therapy (PE) and Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) effectively treat PTSD and chronic pain separately. Studies have found that CBT reduces PTSD symptoms in both the short and long term. For chronic pain, CBT-CP helps individuals manage pain better and reduces reliance on opioids. This trial will evaluate an integrated treatment combining modules from PE and CBT-CP to address the interconnected nature of PTSD and chronic pain. Early evidence suggests that using these therapies together could provide a more comprehensive solution for those facing both conditions. ^{1 6 7 8 9}

Who Is on the Research Team?

JoAnn Difede, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with both PTSD and chronic pain. Participants will engage in virtual psychotherapy sessions twice a week, focusing on exposure to feared situations, relaxation techniques, and more. It's not suitable for those who can't commit to the full course or have conditions that might interfere with treatment.

Inclusion Criteria

Agreed to not change current medication or pain-related treatments over the course of the study unless medically necessary

English-speaking

I have been on the same mental health medication for the last 60 days.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 virtual psychotherapy sessions integrating Prolonged Exposure Therapy and Cognitive Behavioral Therapy for Chronic Pain

6 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Integrated Treatment for PTSD and Chronic Pain

Trial Overview The study tests an integrated therapy combining elements from Prolonged Exposure (PE) for PTSD and Cognitive Behavioral Therapy (CBT) for chronic pain. The goal is to see if treating these issues together through virtual sessions is feasible and helpful.

How Is the Trial Designed?

Group I: Integrated PTSD and Chronic Pain Treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Citations

1. ptsd.va.gov ptsd.va.gov/professional/treat/cooccurring/chronic_pain_guide.asp

Chronic Pain and PTSD - PTSD: National Center for PTSD Provides information and treatment options to providers working with people who have both PTSD and chronic pain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07225049

Integrated PTSD and Chronic Pain Treatment This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07225049?rank=10

Integrated PTSD and Chronic Pain Treatment This is a single-arm pilot study to assess the feasibility and acceptability of an integrated treatment for adults with comorbid PTSD and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3083990/

Cognitive behavioral therapy for the treatment of post ... The current review suggests that CBT is an effective treatment for both acute and chronic PTSD, with both short-term and long-term benefit.

5. mdpi.com mdpi.com/2076-328X/14/11/1103

Intensive Treatment of Chronic Pain and PTSD We developed and pilot-tested the Pain and Trauma Intensive Outpatient Treatment (PATRIOT) Program, a brief, intensive (3 weeks, six sessions) integrated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5803416/

Development of a Novel, Integrated Cognitive-Behavioral ... CPT targets PTSD symptoms through a focus on evaluating and changing trauma-related cognitions, particularly those relevant to five central themes: safety, ...

7. patlynk.com patlynk.com/trial/NCT00127413

Integrated Treatment for Chronic Pain and Posttraumatic ... The purpose of this study is to examine the efficacy of an integrated treatment for Veterans with comorbid chronic pain and posttraumatic stress disorder ...

8. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/prolonged_exposure_pro.asp

Prolonged Exposure for PTSD - National Center for PTSD Results revealed significant reductions in PTSD symptom severity in both PE plus placebo and PE plus sertraline. In an RCT of 916 veterans randomized to PE or ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836418

Advancing Integrated Treatment for Posttraumatic Stress ... This treatment is an evidence-based psychotherapy approach that integrates prolonged exposure—a gold standard treatment for PTSD—with cognitive- ...