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临床试验/NCT07432139
NCT07432139已完成不适用

Efficacy of a Short-Term Emotion-Focused Therapy Intervention for Self-Criticism Compared With a Cognitive-Behavioral Gold Standard: A Randomized Controlled Trial

Catarina Teixeira1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2025年4月17日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
1
主要终点
Level of Self-Criticism

研究概览

简要总结

The goal of this clinical trial is to determine whether Emotion-Focused Therapy (EFT) is an effective approach in reducing self-criticism in adults. EFT will be compared with Cognitive-Behavioral Therapy (CBT), a well-established treatment shown to be effective for a wide range of mental health difficulties.

The main questions the study aims to answer are:

  1. Does EFT reduce self-criticism as effectively as CBT?
  2. How do EFT and CBT compare in their impact on other mental health symptoms?

Participants will:

  1. Receive a six-session, weekly online individual intervention (EFT or CBT), focused on reducing self-criticism.
  2. Complete regular questionnaires during the intervention and at follow-up periods to track changes in self-criticism and other mental health symptoms.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years old
  • Portuguese native speakers
  • elevated self-critical processes
  • perceived impact of the self-critical process on their daily functionality,
  • availability to work with self-critical processes.

排除标准

  • Since self-criticism is a transdiagnostic criteria for various mental disorders, the existence of a specific diagnosis is not in itself an exclusion criterion. However, participants will be excluded in case of
  • elevated dysfunctionality
  • high risk factors (such as suicide risk)
  • severe psychopathology, such as bipolar personality disorder, panic disorder, substance abuse, and personality disorders non adequate to a brief intervention previously identified.
  • changes in the therapeutic plan with psychotropic medication in the last month, if currently taking psychotropic medication
  • psychological treatment maintenance during the study implementation.

研究组 & 干预措施

Emotion Focused Therapy

Experimental

Participants in this arm will receive a six-session, weekly, online individual Emotion-Focused Therapy (EFT) intervention targeting self-criticism. The core of the intervention is the two-chair dialogue, which helps participants identify and process self-critical thoughts and emotions, promote emotional transformation, and integrate different aspects of the self.

干预措施: Emotion Focused Therapy (Behavioral)

Cognitive Behavioral Therapy

Active Comparator

Participants in this arm will receive a six-session, weekly, online individual Cognitive-Behavioral Therapy (CBT) intervention, focused on cognitive restructuring of self-critical thoughts. CBT is a well-established, gold-standard treatment for a broad range of mental health difficulties, and serves as an active comparator to evaluate the efficacy of the EFT intervention. The intervention helps participants identify maladaptive self-criticism, challenging underlying beliefs, and develop more adaptive thought patterns.

干预措施: Cognitive Behavioral Therapy (Behavioral)

结局指标

主要结局

Level of Self-Criticism

时间窗: T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.

Measured using the Forms of Self-Criticizing/Attacking and Self-Reassuring Scale (FSCRS). The FSCRS provides separate scores for Inadequate Self, Hated Self, and Reassured Self. Scores range from 0 to 4, where higher scores indicate greater levels of the respective self-critical or self-reassuring tendencies. Reduction in the Inadequate Self and Hated Self subscales indicates improvement in self-criticism, while increases in Reassured Self indicate improvement in self-compassion.

次要结局

  • Global Symptomatology(T1) Baseline: Within 24 hours prior to Session 1 T2-T6) Pre-session assessment: Within 24 hours before each weekly session (i.e., before sessions 2-6) T7) Post-intervention: 1 week after finalizing Session 6 T8-T9) Follow-ups: 1 and 3 months after T7)
  • Mental Health Continuum - Short Form (MHC-SF):(T1) Baseline: Within 24 hours prior to Session 1. T6) Within 24 hours before Session 6. T7) Post-intervention: 1 week after finalizing Session 6. T8-T9) Follow-up assessments: 1 and 3 months after T7.)
  • Depressive symptomatology(T1) Baseline: Within 24 hours prior to Session 1 T2-T6) Pre-session: Within 24 hours before each weekly session (i.e., before Sessions 2-6) T7) Post-intervention: 1 week after Session 6 is finalized T8-T9) Follow-up assessments: 1 and 3 months after T7)
  • Anxiety Symptomatology(T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session: Within 24 hours before each weekly session (i.e., before Sessions 2-6). T7) Post-intervention: 1 week after Session 6 is finalized. T8-T9) Follow-up: 1 and 3 months after T7.)
  • Self-Esteem(T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.)
  • Affect(T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.)
  • Self-compassion(T1) Baseline: Within 24 hours prior to Session 1. T2-T6) Pre-session assessment : Within 24 hours before each weekly session (i.e., before sessions 2-6). T7) Post-intervention: 1 week after Session 6. T8-T9) Follow-ups: 1 and 3 months after T7.)
  • Working alliance(T5) Only administered within 24 hours prior to Session 5.)

研究者

发起方
Catarina Teixeira
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Catarina Teixeira

Doctoral Student

University of Maia

研究点 (1)

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