Integrated PTSD and Chronic Pain Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Integrated PTSD and Chronic Pain TreatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Feasibility Indicator: Enrollment

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

Time frame
Baseline
3

Feasibility Indicator: Number of Sessions Attended

Feasibility assessment will include the number of sessions attended on average (out of 12).

Time frame
Post-Treatment Assessment at approximately 6 weeks
4

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.

Time frame
Post-Treatment Assessment at approximately 6 weeks

Secondary outcomes

1

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.

Time frame
Baseline to approximately 6 weeks
2

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.

Time frame
Baseline to approximately 6 weeks
3

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.

Time frame
Baseline to approximately 6 weeks
4

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.

Time frame
Baseline to approximately 6 weeks

Other outcomes

Sponsors and contacts

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