Pilot Feasibility Proposal to Adapt Trauma-focused Psychodynamic Psychotherapy (TFPP) for PLWH and PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Psychosis
- •Bipolar I
- •Acute suicidality
- •Current substance use disorder
- •Organic mental syndrome or intellectual disability
- •Unstable non-HIV medical conditions
研究组 & 干预措施
Trauma-focused psychodynamic psychotherapy
Twice-weekly psychotherapy for 24 sessions
干预措施: Trauma-focused psychodynamic psychotherapy (Behavioral)
结局指标
主要结局
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
时间窗: 3-month post-treatment follow-up
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
时间窗: Baseline
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
时间窗: Week 6
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
Change in PTSD Score based on the Clinician Administered PTSD Scale for DSM-5
时间窗: Week 12 (treatment termination)
Lower scores denote less severe PTSD symptoms; a decline of at least 30% from an individual's baseline CAPS score is defined as a treatment response on the CAPS; diagnostic remission will be defined as achieving response plus failing to meet for DSM-5 defined PTSD per the CAPS after treatment.
次要结局
- Change in Depression Score based on the Hamilton Depression Rating Scale (HDRS)(Baseline, Week 12 (treatment termination))
- Change in Anxiety Score based on the Hamilton Rating Scale for Anxiety (HAM-A)(Baseline, Week 12 (treatment termination))
- Change in Functional Impairment based on the Sheehan Disability Scale (SDS)(Baseline, Week 6, Week 12 (treatment termination), 3-month post-treatment follow-up)