Integrated PTSD and Chronic Pain Treatment

Official title

Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain

Overview

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 Indicator: Enrollment [Time frame: Baseline]
• Feasibility Indicator: Number of Sessions Attended [Time frame: Post-Treatment Assessment at approximately 6 weeks]
• Feasibility Indicator: Attrition Percentage [Time frame: Post-Treatment Assessment at approximately 6 weeks]
• Feasibility Indicator: Number of Assessments Attended [Time frame: Baseline and Post-Treatment Assessment at approximately 6 weeks]
• 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)]
• Intervention Satisfaction [Time frame: Post-Treatment Assessment at approximately 6 weeks]
• Intervention Acceptability [Time frame: Post-Treatment Assessment at approximately 6 weeks]
• Qualitative Intervention Feedback [Time frame: Post-Treatment Assessment at approximately 6 weeks]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Weill Cornell Medicine — New York

Identifiers

NCT: NCT07225049 · 25-01028464

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗