NCT04580966

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 5, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 9, 2020

Completed
Last Updated

October 9, 2020

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

October 4, 2020

Last Update Submit

October 8, 2020

Conditions

Keywords

Inquiry Based Stress ReductionIBSRStutteringAdults Who StutterOverall Assessment of the Speaker's Experience of Stuttering"The work"MeditationWell-being

Outcome Measures

Primary Outcomes (1)

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

    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).

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

Secondary Outcomes (3)

  • State-Trait Anxiety Inventory (STAI)

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

  • Psychological Flexibility Questionnaire (PFQ)

    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).

Study Arms (2)

Inquiry Based Stress Reduction (IBSR) workshop

EXPERIMENTAL

Participants of this group received an IBSR intervention workshop.

Behavioral: Inquiry Based Stress Reduction (IBSR) workshop

Control group

NO INTERVENTION

Participants of this group did not take a part in the workshop.

Interventions

The IBSR intervention workshop included weekly group meetings (3.5 hours/meeting) for 12 weeks. During the workshop, participants were encouraged to identify and inquire their stressful thoughts. Using self-inquiry practices participants were taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self-inquiry, participants took an active role in investigating their stressful thoughts, and by this regulated their stress and managed symptoms and emotions, thus enabled them to cope better with the psycho-social consequences of the stuttering.

Also known as: "The Work" meditation (Byron Katie)
Inquiry Based Stress Reduction (IBSR) workshop

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sackler Faculty of Medicine, Tel Aviv University

Tel Aviv, 6139001, Israel

Location

MeSH Terms

Conditions

Stuttering

Condition Hierarchy (Ancestors)

Speech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2020

First Posted

October 9, 2020

Study Start

November 5, 2017

Primary Completion

August 23, 2018

Study Completion

August 23, 2018

Last Updated

October 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations