跳至主要内容
临床试验/NCT05791760
NCT05791760招募中不适用

Effectiveness of Compassion Focused Therapy (CFT) for Reducing Self-criticism in Female Patients with Complex PTSD: a Single-case Experimental Study

University of Twente2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
Self-criticism

研究概览

简要总结

PTSD is a mental disorder including psychological symptoms related to severe traumatic event(s). PTSD can negatively affect people's functioning in several life domains. Several effective therapies for the treatment of PTSD have been developed in recent decades. However, these treatments are not effective for every patient. Several studies show that people suffering from PTSD also experience feelings of trauma-related guilt, shame, self-blame and negative self-evaluation. These emotions may contribute to the maintenance cycle of PTSD or even become worse over time. In particularly in patients with trauma who have been exposed to repeated traumatic experiences within the context of interpersonal relationships including childhood sexual/physical abuse and domestic violence. This type of trauma is known as complex PTSD. cPTSD is marked by severe difficulties in problems with self and emotion-regulation, relationship difficulties and shame. One key factor for reducing self-criticism in individuals might be self-compassion as the antidote to self-criticism and shame. Compassion focused therapy by Paul Gilbert focuses specifically on increasing self-compassion. Although some studies show promising results of CFT in patients with cPTSS, the effectiveness for this group has not yet been sufficiently examined. Therefore, this Single case experimental design study is conducted with the primary objective of examining the effectiveness of CFT in reducing the primary outcome self-criticism. Secondary outcomes that will be examined are CFT reduces PTSD symptoms and shame and increases self-compassion and well-being.

This SCED study is a noncurrent multiple baseline across subjects study, consisting of three phases with twice-weekly repeated measurements of self-criticism. First the pre-intervention baseline phase, in which participants are randomly assigned to different baseline lengths (either 5, 6 or 7 weeks). The second phase is the subsequent CFT-intervention, consisting of 12 weeks of weekly CFT group sessions with two-weekly assessments of self-criticism. The third phase is follow up for 5 weeks from the end of the intervention, again including two-weekly assessments of self-criticism. By comparing the baseline phases with the intervention and follow-up phases for individual participants, the effectiveness of the CFT intervention on self-critical beliefs can be determined. Changes that occur within participants can be seen as evidence of intervention effectiveness.

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

入选标准

  • The participant is between 18 and 65 years old.
  • Diagnosis of cPTSD and severe problems with self criticism (as diagnosed by an experienced clinican).
  • The participant gives consent to participate in the study using the online informed consent procedure.
  • Sufficient Dutch language proficiency and average intelligence.
  • The participant has an e-mail address and is in possession of a smartphone or tablet with access to the internet.
  • The participant is willing to complete twice-weekly questionnaires for up to 24 weeks.
  • Exclusion criteria

排除标准

  • 未提供

结局指标

主要结局

Self-criticism

时间窗: Up to 24 weeks

Measured with the Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS-SF). It contains 14 items and is a valid and sensitive measurement scale with adequate psychometric properties including structural validity, convergent validity and sensitivity to change. Higher scores indicate more self-criticism and more self-reassurance. Mean scores range from 0 to 4.

次要结局

  • Well-being(Posttest (T1); 3 months after baseline)
  • Self-compassion(Posttest (T1); 3 months after baseline)
  • PTSD symptoms(Posttest (T1); 3 months after baseline)
  • Shame(Posttest (T1); 3 months after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jannis Kraiss

Assistant professor, Principal Investigator

University of Twente

研究点 (2)

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