A Pilot Randomized Controlled Trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) at the VA in Veterans With PTSD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
研究概览
简要总结
This is a randomized controlled trial of Trauma-Focused Psychodynamic Psychotherapy (TFPP) in comparison with TAU (at the VA) in a 2:1 ratio in 75 Veterans with PTSD who have not responded to standard treatment at the VA.
详细描述
Veterans with PTSD are a highly vulnerable population with tremendous disability and unmet needs. Few VA patients with PTSD now actually receive evidence-based psychotherapy because current exposure-based treatments have low uptake. The project goal is to expand the range of PTSD psychotherapy treatments available at Veterans Administration Medical Centers. This pilot trauma recovery proposal takes the next step in translating a brief efficacious psychotherapy developed and tested for panic disorder, Panic Focused Psychodynamic Psychotherapy (PFPP) for Veterans with PTSD at the VA New York Harbor Healthcare System (VA NYHHCS). PFPP was developed, manualized, and studied in RCTs over the past two decades. We hope that Trauma-Focused Psychodynamic Psychotherapy (TFPP), an adaptation of PFPP, with its high response rates in panic disorder with/without agoraphobia, and non-exposure protocol, will fill crucial gaps in Veteran care. A major challenge facing psychotherapy research is translating and implementing efficacious therapies to the community. No psychodynamic psychotherapy for anxiety or PTSD has achieved this in the US. This pilot RCT represents a paradigm shift in its approach to trauma. TFPP will be the only PTSD treatment for Veterans to incorporate Veterans' input into refinement of the treatment as this project progresses. TFPP targets aspects of traumatic experience and approaches Veterans' lives more broadly than the symptom-focused treatments the VA currently offers our traumatized Veterans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
All assessments will be performed by blinded clinical assessors; randomization accomplished by computer algorhythm
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Reporting moderate PTSD, as defined by a CAPS score of >40
- •Have at least one of the following history with CPT and/or PE:
- •offered and declined
- •dropped out of treatment
- •been determined unsuitable by their treatment team
- •received treatment but continue to experience symptoms meeting entrance criteria.
- •Require stabilization on psychiatric medication for 2 month period prior to entry into study to avoid confounding treatments
排除标准
- •Presence of SCID-5 assessed psychotic disorder, bipolar disorder, or substance use that would interfere with trial demands
- •Severe suicidality that would require immediate crisis management
- •Organic mental syndromes, delirium, or unstable medical conditions that would interfere with trial demands
- •Inability to meet trial demands.
研究组 & 干预措施
TAU
TAU in this study is treatment for PTSD as currently delivered at the VA
干预措施: TAU (Other)
结局指标
主要结局
Change in PTSD symptoms as per DSM-5 as measured by CAPS-5
时间窗: baseline, 16 weeks (termination), 3 month follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Low score indicates fewer PTSD symptoms, high score indicates more PTSD symptoms.
次要结局
- Change in reflective capacity as measured by RF score.(baseline, 16 weeks (termination), 3 month follow-up)
- Change in mental and physical symptoms as measured by VR-12.(baseline, 16 weeks (termination), 3 month follow-up)
- Childhood abuse history and trauma with CTQ(baseline)
- Change in anxiety symptoms as measured by HARS.(baseline, 16 weeks (termination), 3 month follow-up)
- Change in degree of limitation in ability to work as measured by WLQ(baseline, 16 weeks (termination), 3 month follow-up)
- Change in depression symptoms as measured by HDRS.(baseline, 16 weeks (termination), 3 month follow-up)
- Change in work and social adjustment as measured by WSAS.(baseline, 16 weeks (termination), 3 month follow-up)
- Change in adult separation anxiety symptoms as measured by the SCI-SAS(baseline, 16 weeks (termination), 3 month follow-up)
- Assessment of life events on LEC.(baseline)