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IBSR Intervention for Adults Who Stutter

Primary Purpose

Stuttering

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Inquiry Based Stress Reduction (IBSR) workshop
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stuttering focused on measuring Inquiry Based Stress Reduction, IBSR, Stuttering, Adults Who Stutter, Overall Assessment of the Speaker's Experience of Stuttering, "The work", Meditation, Well-being

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sackler Faculty of Medicine, Tel Aviv University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inquiry Based Stress Reduction (IBSR) workshop

Control group

Arm Description

Participants of this group received an IBSR intervention workshop.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

State-Trait Anxiety Inventory (STAI)
The STAI questionnaire assess the tendency of adults to experience anxiety and to inspect their sensitivity to anxiety-provoking situations. The questionnaire distinguishes between two scales of anxiety: anxiety as a state and anxiety as a trait. State anxiety is a person's tendency to experience anxiety in certain situations and times, depending on their context. Trait anxiety is a person's constant and stable tendency to experience anxiety frequently. Each item is rated on a 4-point Likert scale. After completing the questionnaire, items scores are added to obtain total scores. Responders receives 2 separate total scores, one for each of the scales. The maximum score for each scale is 80 and the minimum score is 20. In both scales, scores between 20 to 40 is considered normal in the general adult population. The higher the score, the higher the anxiety level (Spielberger et al., 1970; Taychman & Malinek, 1984).
Psychological Flexibility Questionnaire (PFQ)
The aim of PFQ questionnaire is to measure the psychological flexibility of the test responder. Psychological flexibility describes a person's ability to be open, to perceive change as positive, to focus on the present and to change or persist in behavior according to changes of internal and external circumstances. The questionnaire consists of 20 items rated on a 6-point Likert scale. Each item is associated with one of 5 factors that refers to a significant domain in psychological flexibility. The 5 factors are: 1. Positive perception of change. 2. Characterization of the self as flexible. 3. Self-characterizing as open and innovative. 4. A perception of reality as dynamic and changing. 5. A perception of reality as "multifaceted". The score of the questionnaire is calculated based on the mean of the 20 items. Higher score indicates high level of psychological flexibility (Ben-Itzhak et al., 2014).
Satisfaction with Life Scale (SWLS)
The SWLS questionnaire evaluates the person's overall satisfaction with life, based on personal criteria that he defined for himself and based on his perception of life. In the questionnaire, there is 5 items that the subjects are required to rate using a 7-point Likert scale. The five items are summed to create a total score that ranged from 5 to 35, with a higher score indicates greater satisfaction with the subject's life. A final grade in the range of 30-35 is a very high score, indicating a person with great satisfaction and very satisfied with his life (Diener, 1994; Diener et al., 1985).

Full Information

First Posted
October 4, 2020
Last Updated
October 8, 2020
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04580966
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
August 23, 2018 (Actual)
Study Completion Date
August 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inquiry Based Stress Reduction (IBSR) workshop
Arm Type
Experimental
Arm Description
Participants of this group received an IBSR intervention workshop.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants of this group did not take a part in the workshop.
Intervention Type
Behavioral
Intervention Name(s)
Inquiry Based Stress Reduction (IBSR) workshop
Other Intervention Name(s)
"The Work" meditation (Byron Katie)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A)
Description
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).
Time Frame
1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Secondary Outcome Measure Information:
Title
State-Trait Anxiety Inventory (STAI)
Description
The STAI questionnaire assess the tendency of adults to experience anxiety and to inspect their sensitivity to anxiety-provoking situations. The questionnaire distinguishes between two scales of anxiety: anxiety as a state and anxiety as a trait. State anxiety is a person's tendency to experience anxiety in certain situations and times, depending on their context. Trait anxiety is a person's constant and stable tendency to experience anxiety frequently. Each item is rated on a 4-point Likert scale. After completing the questionnaire, items scores are added to obtain total scores. Responders receives 2 separate total scores, one for each of the scales. The maximum score for each scale is 80 and the minimum score is 20. In both scales, scores between 20 to 40 is considered normal in the general adult population. The higher the score, the higher the anxiety level (Spielberger et al., 1970; Taychman & Malinek, 1984).
Time Frame
1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Title
Psychological Flexibility Questionnaire (PFQ)
Description
The aim of PFQ questionnaire is to measure the psychological flexibility of the test responder. Psychological flexibility describes a person's ability to be open, to perceive change as positive, to focus on the present and to change or persist in behavior according to changes of internal and external circumstances. The questionnaire consists of 20 items rated on a 6-point Likert scale. Each item is associated with one of 5 factors that refers to a significant domain in psychological flexibility. The 5 factors are: 1. Positive perception of change. 2. Characterization of the self as flexible. 3. Self-characterizing as open and innovative. 4. A perception of reality as dynamic and changing. 5. A perception of reality as "multifaceted". The score of the questionnaire is calculated based on the mean of the 20 items. Higher score indicates high level of psychological flexibility (Ben-Itzhak et al., 2014).
Time Frame
1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Title
Satisfaction with Life Scale (SWLS)
Description
The SWLS questionnaire evaluates the person's overall satisfaction with life, based on personal criteria that he defined for himself and based on his perception of life. In the questionnaire, there is 5 items that the subjects are required to rate using a 7-point Likert scale. The five items are summed to create a total score that ranged from 5 to 35, with a higher score indicates greater satisfaction with the subject's life. A final grade in the range of 30-35 is a very high score, indicating a person with great satisfaction and very satisfied with his life (Diener, 1994; Diener et al., 1985).
Time Frame
1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sackler Faculty of Medicine, Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
6139001
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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IBSR Intervention for Adults Who Stutter

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