Open Trial of Trauma-focused Psychodynamic Psychotherapy for People Living With HIV and PTSD

Официальное название

Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD

Обзор

People living with HIV (PLWH) have a higher rate of post-traumatic stress disorder (PTSD) diagnosis than the general population. Comorbid PTSD is also associated with negative HIV-related health outcomes. Unfortunately, little outcome research has examined the usefulness of PTSD treatments for PTSD. This pilot study adapts for PLWH a non-exposure based psychotherapy for PTSD focused on reflecting on one's emotions and relationships and understanding and working through how trauma may have disrupted them. The study team is interested in better understanding the needs of PLWH with PTSD, learning whether PLWH with PTSD find this treatment acceptable and helpful, and beginning to understand the relationship between HIV-related health factors (e.g., inflammation and stress biology) and PTSD, and how these health factors may improve during treatment.

Вмешательства

• Поведенческое Trauma-focused psychodynamic psychotherapy
  This psychotherapy addresses disruptions in the ability to reflect and affective regulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with author

Первичные конечные точки

• Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [Срок оценки: Baseline]
• Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [Срок оценки: Week 6]
• Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [Срок оценки: Week 12 (treatment termination)]
• Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5 [Срок оценки: 3-month post-treatment follow-up]

Вторичные конечные точки (3)

• Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS) [Срок оценки: Baseline, Week 12 (treatment termination)]
• Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A) [Срок оценки: Baseline, Week 12 (treatment termination)]
• Change in Functional Impairment based on the Sheehan Disability Scale (SDS) [Срок оценки: Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up]

Критерии участия

Критерии включения

• Diagnosis of DSM-5 defined PTSD, per the Clinician Administered PTSD Scale \& CAPS-5 total severity score greater than or equal to 25
• HIV diagnosis (by medical records or HIV testing)
• Stable psychiatric/psychotropic medication for >=2 months and ongoing during treatment

Критерии исключения

• Psychosis
• Bipolar I
• Acute suicidality
• Current substance use disorder
• Organic mental syndrome or intellectual disability
• Unstable non-HIV medical conditions

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

• Albert Einstein College of Medicine — The Bronx

Публикации

• Kehn M, Milrod B, Chen CK. Clinical Case of Trauma-Focused Psychodynamic Psychotherapy for a Veteran With PTSD and Race-Based Trauma. Am J Psychother. 2024 Sep 1;77(3):146-150. doi: 10.1176/appi.psychotherapy.20230040. No abstract available. PMID 39277802

Идентификаторы

NCT: NCT05929911 · 2023-15016 · P30AI124414

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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