跳至主要内容
临床试验/NCT04580966
NCT04580966已完成不适用

The Effect of "Inquiry Based Stress Reduction" (IBSR) on the Overall Stuttering Experience, Quality of Life and Psychological Indicators Among Adults Who Stutter a Randomized Controlled Clinical Trial

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2017年11月5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
56
试验地点
2
主要终点
Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A)

研究概览

简要总结

Stuttering is a speech disorder that can cause disturbances in the timing and flow of speech. It is often accompanied not only by verbal difficulties but also by negative impact on several psycho-social aspects in the life of the people who stutter.

Recently, clinical evidences have shown the effectiveness of Inquiry Based Stress Reduction (IBSR) technique to improve psychosocial symptoms and enhance well-being in clinical and non-clinical samples. IBSR, the clinical application of Byron Katie's "The Work", enables individuals to mindfully spot and investigate in a systematic and comprehensive manner thoughts that lead to stress and suffering by a series of questions and turnarounds. IBSR was found to have significantly positive influence on the quality of life, mental well-being and stress management in a variety of populations which suffer from elevated levels of stress, suffering, tension and anxiety, and to enhance resilience of non-clinical general population.

In our research we hypothesized that:

  1. Adults who stutter will have high levels of anxiety, and low levels of psychological flexibility and satisfaction with life.
  2. IBSR intervention will improve experience of stuttering in adults who stutter.
  3. IBSR will decrease anxiety levels and enhance psychological flexibility and satisfaction with life.

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

  • Diagnosis of either developmental or acquired stuttering.
  • Age of 18 years or above.
  • Capability to understand and fill out the study outcome instruments and informed consent form.

排除标准

  • Diagnosis of severe mental illness.
  • Inability to understand or read Hebrew.
  • Subjects who declare they can not take a part in the trial throughout its whole duration.

结局指标

主要结局

Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A)

时间窗: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).

The purpose of OASES-A questionnaire is to assess the overall stuttering experience of adults who stutter. It quantifies the quality of life, satisfaction and overall personal experience of the adult in his daily coping with stuttering. The items in the questionnaire are divided into four main sections: 1. General information on stuttering awareness and perception. 2. Reactions to stuttering. 3. Communication in daily situations. 4. Quality of life. The OASES-A total score is obtained by summing the scores of the four different sections. In this trial we used the Hebrew version of this questionnaire. OASES-A total score and the score for each of the sections (in the Hebrew version) is ranging from 1.0 to 5.0. The score rates the severity of the stuttering experience, where 1.0 indicates a mild impact rating and 5.0 a severe impact rating (higher scores indicate a more negative impact of stuttering) (Freud et al., 2017; Yaruss \& Quesal, 2006).

次要结局

  • Psychological Flexibility Questionnaire (PFQ)(1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).)
  • State-Trait Anxiety Inventory (STAI)(1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).)
  • Satisfaction with Life Scale (SWLS)(1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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