The effectiveness of Mindfulness and Acceptance Group Therapy in comparison with Cognitive Behavioral Group Therapy on severity of social anxiety, quality of life, and verbal fluency in adults with stuttering
To determine the effectiveness of Mindfulness and Acceptance Group Therapy plus Speech Therapy in comparison to Cognitive Behavioral Group Therapy plus Speech therapy and speech therapy as control group on the severity of social anxiety, quality of life, and verbal fluency in adults with stuttering
Design
The present study will be a randomly assigned clinical trial with control group and each group will have 18 participants. First, All three groups will evaluate simultaneously. After the completion of psychotherapy in the treatment groups, all three groups will be reevaluated and speech therapy will begin for all three groups. Upon completion of speech therapy, the evaluations will be done at the end.
Settings and conduct
This research will be done in a speech therapy clinic. Each treatment group will consist of 8 to10 participants randomly assigned and will receive 10 sessions of psychotherapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Developmental Stuttering diagnosed by speech pathologist;
Fluency in speaking Persian;
Age more than 20 years;
The level of education above 9th grade (because patients less than 9 years education may have problems with exercises).
The social anxiety score must be higher than the average according to SPAI;
Exclusion criteria:
Psychotic disorders;
Dependence or drug abuse;
Other psychiatric disorders in such an intensity that have priority for participants and/or participants could not bear group therapy.
Intervention groups
Research groups
1. Mindfulness and Acceptance Group Therapy plus speech therapy
2. Cognitive Behavioral Group Therapy plus speech therapy
3. Speech Therapy Group as Control Group
Main outcome variables
The severity of social anxiety;
Quality of life;
Verbal Fluency.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181206041868N1
Registration date:2020-03-27, 1399/01/08
Registration timing:prospective
Last update:2020-03-27, 1399/01/08
Update count:0
Registration date
2020-03-27, 1399/01/08
Registrant information
Name
Soroush Khoshnam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5543 3154
Email address
khoshnam.s@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Mindfulness and Acceptance Group Therapy in comparison with Cognitive Behavioral Group Therapy on severity of social anxiety, quality of life, and verbal fluency in adults with stuttering
Public title
Mindfulness and Acceptance and Cognitive Behavioral Group Therapy on adult stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis: developmental stuttering
language: Persian
Age: more than 20 years
Education: more than 8 classes
Social phobia: moderate and severe
Exclusion criteria:
Psychotic disorders
Drug dependency disorders
Any other primary psychiatric disorders which be so severe that the participant could not tolerate group therapies
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using blocked randomization with fixed block sizes. The size of the blocks will be 6 and randomization will be performed using www.sealedenvelope.com. We will have 9 blocks which every one of them has 6 members (n=54) and the members will be replaced by random sequences created by the website. In each block, two participants will be randomly assigned to group A (Mindfulness and Acceptance Group Therapy), two participants to group B (Cognitive Behavioral Group Therapy), and two participants to group C (Control Group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.IUMS.REC.1397.1315
Health conditions studied
1
Description of health condition studied
adult stuttering
ICD-10 code
F98.5
ICD-10 code description
Stuttering [stammering: ]Speech that is characterized by frequent repetition or prolongation of sounds or syllables or words, or by frequent hesitations or pauses that disrupt the rhythmic flow of speech. It should be classified as a disorder only if its
2
Description of health condition studied
social phobia
ICD-10 code
F40.1
ICD-10 code description
Social phobias: Fear of scrutiny by other people leading to avoidance of social situations. More pervasive social phobias are usually associated with low self-esteem and fear of criticism. They may present as a complaint of blushing, hand tremor, nausea,
Primary outcomes
1
Description
severity of social anxiety
Timepoint
The evaluation of severity of social anxiety before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up
Method of measurement
Social Phobia and Anxiety Inventory
2
Description
Quality of life
Timepoint
The evaluation of quality of life before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up
Method of measurement
Overall Assessment of the Speaker's Experience of Stuttering-Adults
3
Description
Severity of Stuttering
Timepoint
The evaluation of severity of stuttering before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up
Method of measurement
Stuttering Severity Instrument-3
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Mindfulness and Acceptance Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs sessions group therapy which will have two parts; In first 5 sessions, participants will practice Mindful exercises in addition to learning therapy concepts and in second 5 sessions, Vital Actions. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until they can use these techniques in reading and daily speech with normal speed range.
Category
Treatment - Other
2
Description
Second Intervention group: Cognitive Behavioral Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs session group therapy which will have two parts. In first 5 sessions, participants will learn cognitive restructuring and in second 5 sessions practice Behavioral experiments and exposures. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range.
Category
Treatment - Other
3
Description
Control group: Speech Therapy (Smooth Speech); After being in waiting list and post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Behavioral Sciences and Mental Health (Tehran Institute of psychiatry)
Full name of responsible person
Soroush Khoshnam
Street address
No, 1, Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
soroushkhoshnam@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed kazem Malakouti
Street address
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1655
Email
Ertebat.tip@iums.ac.ir
Web page address
http://tip.iums.ac.ir/fa?sid=35
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soroush Khoshnam
Position
PhD Student of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1655
Email
soroushkhoshnam@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Banafshe Gharraee
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1655
Email
gharraee.b@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Soroush Khoshnam
Position
PhD Student of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6655 1655
Email
Soroushkhoshnam@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
1. Study protocols
2. Clinical study report
3. Statistical Analysis Map
4. Consent Conscious Form
When the data will become available and for how long
No more information
To whom data/document is available
No more information
Under which criteria data/document could be used
No more information
From where data/document is obtainable
No more information
What processes are involved for a request to access data/document
No more information
Comments
The results of this research will be published in the form of Ph.D. thesis and an ISI Article.