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临床试验/NCT05155930
NCT05155930已完成不适用

Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy for Trauma-related Symptoms Among Complexly Traumatized Adults

Justice Resource Institute0 个研究点目标入组 17 人开始时间: 2014年3月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
主要终点
Change in Clinician Administered PTSD Scale (CAPS) total score from pre- to post-treatment and 1-month follow up

研究概览

简要总结

Study examining the effectiveness of 16 weeks of Internal Family Systems (IFS) therapy for adults with posttraumatic stress disorder (PTSD).

详细描述

Evaluation study of IFS therapy among trauma-impacted adults in order to explore the applicability of IFS with this population, ensure fidelity of treatment administration, and examine initial efficacy. Evaluate the utility of IFS in reducing symptoms of PTSD, dissociation and depression and increasing self-regulatory capacity, self-awareness and self-compassion. 15 subjects between the ages of 18 and 56 who are receiving 16, 90-minute sessions of IFS therapy by certified IFS practitioners in the community will be recruited for this evaluation study. Blind evaluators will assess treatment effects at pre-treatment, mid-treatment, post-treatment and at one-month follow-up, measuring change in symptoms of PTSD, dissociation and depression, as well as self-regulation, self-compassion, and interoceptive awareness.

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 56 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals between 18 and 58 years old, any race.
  • A minimum two traumatic events prior to the age of 18 years.
  • Current PTSD diagnosis per CAPS assessment with total symptom scores indicative of a moderate degree of severity (i.e. CAPS total score between 55 and 80).
  • Clinically significant depressive symptoms as indicated by a total score of 14 or above on the BDI.

排除标准

  • Diagnosis of schizophrenia, DID, Bipolar Disorder or other psychotic disorder not stated above.
  • Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria and judged by the PI.
  • Current legal proceedings resulting from the traumatic events.
  • Previous treatment in IFS.

结局指标

主要结局

Change in Clinician Administered PTSD Scale (CAPS) total score from pre- to post-treatment and 1-month follow up

时间窗: Change from baseline in PTSD symptom severity at up to 16 weeks of treatment and 1-month follow up.

A 30-item validated instrument that contains frequency and intensity scales for PTSD symptoms . Subscales assess intrusion, avoidance, arousal and associated affective features.

次要结局

  • Change in symptoms of depression per the Beck Depression Inventory (BDI) across 4 study time points(Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.)
  • Change in interoceptive awareness per the Multidimensional Assessment of Interoceptive Awareness (MAIA) across 4 study time points(Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.)
  • Change in PTSD symptoms per the Davidson Trauma Scale (DTS) across four study time points(Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.)
  • Change in symptoms of dissociation per the Structured Interview for Disorders of Extreme Stress, Self-Report Version (SIDES-SR) over 4 study time points(Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.)
  • Change in self-compassion per the Self Compassion Scale over four study time points(Change from baseline in PTSD symptom severity at up to 8 weeks of treatment, 16 weeks of treatment and 1-month follow up.)

研究者

申办方类型
Other
责任方
Sponsor

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