Integrated PTSD and Chronic Pain Treatment

Официальное название

Pilot of an Integrated Treatment for Comorbid PTSD and Chronic Pain

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Feasibility Indicator: Number of Participants Screened [Срок оценки: Baseline]
• Feasibility Indicator: Enrollment [Срок оценки: Baseline]
• Feasibility Indicator: Number of Sessions Attended [Срок оценки: Post-Treatment Assessment at approximately 6 weeks]
• Feasibility Indicator: Attrition Percentage [Срок оценки: Post-Treatment Assessment at approximately 6 weeks]
• Feasibility Indicator: Number of Assessments Attended [Срок оценки: Baseline and Post-Treatment Assessment at approximately 6 weeks]
• Feasibility Indicator: Percentage of Self-Reports Completed [Срок оценки: Baseline, Post-Intervention at approximately 6 weeks, Every Other Treatment Session (Every 2 weeks up to 12 weeks)]
• Intervention Satisfaction [Срок оценки: Post-Treatment Assessment at approximately 6 weeks]
• Intervention Acceptability [Срок оценки: Post-Treatment Assessment at approximately 6 weeks]
• Qualitative Intervention Feedback [Срок оценки: Post-Treatment Assessment at approximately 6 weeks]

Вторичные конечные точки (12)

• Change in Score on the Clinician Administered PTSD Score (CAPS-5) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the PTSD Checklist for DSM-5 (PCL-5) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Pain Severity Subscale of the Brief Pain Inventory (BPI) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Pain Interference Subscale of the Brief Pain Inventory (BPI) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Chronic Pain Acceptance Questionnaire (CPAQ) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Posttraumatic Cognitions Inventory (PTCI) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Fear-Avoidance Components Scale (FACS) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Anxiety Sensitivity Index (ASI-3) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Expectancies for Alcohol Analgesia (EAA) Measure [Срок оценки: Baseline to approximately 6 weeks]
• Change in Score on the Difficulties in Emotion Regulation Scale (DERS-18) [Срок оценки: Baseline to approximately 6 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Weill Cornell Medicine — New York

Идентификаторы

NCT: NCT07225049 · 25-01028464

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗