StutteringNCT04580966
IBSR Intervention for Adults Who Stutter
A study testing Inquiry Based Stress Reduction (IBSR) workshop in people with Stuttering, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stuttering
- What is being tested?
- Inquiry Based Stress Reduction (IBSR) workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Nov 2017to 23 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sackler Faculty of Medicine, Tel Aviv University
Tel Aviv, 6139001
About this study
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
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.
Read more
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.
- Conditions
- Stuttering
- Being tested
- Inquiry Based Stress Reduction (IBSR) workshop
- Keywords
- Inquiry Based Stress Reduction, IBSR, Stuttering, Adults Who Stutter, Overall Assessment of the Speaker's Experience of Stuttering, "The work", Meditation, Well-being
- Medical subject headings
- Stuttering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inquiry Based Stress Reduction (IBSR) workshopBehavioural
Also called "The Work" meditation (Byron Katie)
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.
| Study group | Role | What they receive |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) workshop | Experimental | Participants of this group received an IBSR intervention workshop. Receives: Behavioral: Inquiry Based Stress Reduction (IBSR) workshop |
| Control group | No intervention | Participants of this group did not take a part in the workshop. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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).
Measured: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
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).
Measured: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
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).
Measured: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start5 Nov 2017
- Primary completion23 Aug 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580966
- Sponsor's protocol ID
- IBSR-Stuttering
- Status last verified
- Oct 2020
- First submitted
- 4 Oct 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04580966
- Acronym / sponsor ID
- IBSR-Stuttering
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) workshop | Experimental | Behavioral: Inquiry Based Stress Reduction (IBSR) workshopParticipants of this group received an IBSR intervention workshop. |
| Control group | No intervention | –Participants of this group did not take a part in the workshop. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inquiry Based Stress Reduction (IBSR) workshopAlso: "The Work" meditation (Byron Katie)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. | Behavioural | Inquiry Based Stress Reduction (IBSR) workshop |
Primary outcome
Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A)
Time frame: 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).
3 secondary outcomes
State-Trait Anxiety Inventory (STAI)
Time frame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Psychological Flexibility Questionnaire (PFQ)
Time frame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Satisfaction with Life Scale (SWLS)
Time frame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inquiry Based Stress Reduction (IBSR) workshop in people with Stuttering, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Assessment of the Speaker's Experience of Stuttering for Adults (OASES-A) (time frame: 1) Baseline (Before the workshop (T1)). 2) Immediately after the workshop (T2). 3) One month after the workshop (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.