Clinical trial NCT04580966: IBSR Intervention for Adults Who Stutter
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stuttering
Keywords: Inquiry Based Stress Reduction
IBSR
Stuttering
Adults Who Stutter
Overall Assessment of the Speaker's Experience of Stuttering
"The work"
Meditation
Well-being
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A)
timeFrame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
measure: Psychological Flexibility Questionnaire (PFQ)
timeFrame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
measure: Satisfaction with Life Scale (SWLS)
timeFrame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sackler Faculty of Medicine, Tel Aviv University
Study officials:
References: