Comparison of the Effectiveness of Schema Therapy and Cognitive-Speech Integrative Approach on Emotional Regulation and Negative ¬ Emotions and distress tolerance of People with Stuttering
Comparison of the effectiveness of schema therapy and integrated cognitive- speech approach on emotional regulation, negative emotions and anxiety tolerance of people with stuttering
Design
In this study, two exprimental groups, Schema Therapy(10), Cognitive-Speech Integrative Approach(10) and one control group were selected by simple and parallel randomaly.
Settings and conduct
The method of this research is quasi-experimental and its design is pre-test, post-test and follow-up plan with the control group. Access will be replaced in three simple random groups. The experimental group will complete the schema therapy and the experimental group will complete the integrated cognitive-verbal approach of emotion regulation questionnaires and positive and negative emotions and distress tolerance (pre-test). Then the experimental groups will be treated and the control group will be on a waiting list. At the end of the post-test is done. In the last sessions, the tests will be followed up. Finally, the data will be collected and statistically analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with stuttering, aged 18 to 30 years.
Criteria for non-admission: at least two sessions absent; use of psychotropic drugs, medical and personality disorders, receiving simultaneous drug therapy courses.
Intervention groups
1- Control Schema therapy,
2- Control Integrated cognitive-verbal approach
3- Control group
Comparison of the Effectiveness of Schema Therapy and Cognitive-Speech Integrative Approach on Emotional Regulation and Negative ¬ Emotions and distress tolerance of People with Stuttering
Public title
Comparison of the Effectiveness of Schema Therapy and Cognitive-Speech Integrative Approach on Emotional Regulation and Negative ¬ Emotions and distress tolerance of People with Stuttering
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Participants with stuttering
The Participants between 18- 30 years of age
The Participants should not have any psychological problems
Exclusion criteria:
Absent more than two sessions,
Use of psychotropic drugs,
Clinical and personality disorders,
Receiving simultaneous drug therapy courses
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The selected people are given a unique code, we write the specific codes of the whole sample size on separate sheets, put them in a box and then take them out of the box one by one and put them in order into experimental group of schema therapy, the experimental group of integrated cognitive-speech approach and the control group. We continue this method until a total of 30 people are randomly divided into three groups.
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
Research Ethics Committee of Islamic Azad University,NEYSHABUR.
Street address
Ebne Yamine Street - Ebne Yamine 40 Corner- Pezhvak Rehibilation Center
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613887575
Approval date
2020-07-31, 1399/05/10
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1399.006
Health conditions studied
1
Description of health condition studied
People with Stuttering
ICD-10 code
F80.81
ICD-10 code description
Childhood onset fluency disorder
Primary outcomes
1
Description
Emotional regulation variables
Timepoint
- Pre-test: at the beginning of the study (before the intervention) - Post-test: three months after the beggining of intervention - Follow-up test: 2 months after the intervention
Method of measurement
Questionnaire: consist of two subscales of 6-item reassessment and 4-item repression. Participants respond on a 7-point Likert scale from strongly disagree (with a score of 1) to strongly agree (with a score of 7).
2
Description
The negative emotions variable
Timepoint
Post-test, pre-test, follow-up test
Method of measurement
Questionnaire: consist of 10 items. In front of each item, there is a range of 5 options from very low (score 1) and very high (score 5), which is ranked by the subject and the range of scores for each subscale is 10 to 50.
3
Description
The distress tolerance variable
Timepoint
- Pre-test: at the beginning of the study (before the intervention) - Post-test: three months after the intervention - Follow-up test: 2 months after the intervention
Method of measurement
Questionnaire: consist of 15 items and four sub-scales of tolerance (emotional distress tolerance), absorption (absorption of stress by negative emotions), evaluation (mental estimation of distress) and adjustment (adjustment of efforts to relieve distress). The scoring method is scored on a five-point scale (1: strongly agree; 2: slightly agree; 3: neither agree nor disagree; 4: slightly disagree and 5: strongly disagree).
Secondary outcomes
1
Description
Quality of life variable has 4 subscales and an overall score. These subscales include: physical health, mental health, social relationships, environmental health, and an overall score. Initially, a raw score is obtained for each subscale, which must be converted to a standard score between 0 and 100 through a formula. A higher score indicates a higher quality of life
Timepoint
Second Quarter of 2019
Method of measurement
Questionnaire
Intervention groups
1
Description
Schema therapy: Schema therapy consists of a set of techniques that will be performed in a 12-session course of treatment, each session will last 90 minutes (Young et al., 2003).
Category
Behavior
2
Description
Integrated cognitive-speech approach: This therapeutic approach was formulated by Farazi (2013) in a structured manner. Our intervention will be included 12 specific treatment sessions (initial assessment, individual and group therapeutic interventions and final assessment) on stuttering in adults aged 18-30 years in an organized manner. , Purposeful and coherent in four sections, psychological reconstruction of speech and reading, psychological reconstruction of stuttering, cognitive reconstruction and group therapy sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pezhvak Rehabilitation Center
Full name of responsible person
Fateme Kuhestani
Street address
Ebne Yamine Street - Ebne Yamine 40
City
Szbzevar
Province
Razavi Khorasan
Postal code
9613887575
Phone
+98 51 4467 3282
Fax
+98 51 4422 3594
Email
pezvaktavan@yahoo.com
2
Recruitment center
Name of recruitment center
Newsha Speech Therapy Clinic
Full name of responsible person
Kazem Farzin far
Street address
East Golshan Street- Corner Golshan 6
City
Sabzevar
Province
Razavi Khorasan
Postal code
9618746754
Phone
+98 51 4423 3094
Fax
+98 51 4422 3594
Email
kazemfarzin58@yahoo.com
3
Recruitment center
Name of recruitment center
Pezhvak Speech Therapy Clinic
Full name of responsible person
Reza Malajardi
Street address
Kashfi Street - Kashfi 12
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617643316
Phone
+98 51 4467 3004
Fax
+98 51 4422 3594
Email
kfarzinfar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pezhvak Rehabilitation Center
Full name of responsible person
Kazem Farzinfar
Street address
Ebne Yamine Street - Corner Ebne Yamine 40
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613887575
Phone
+98 51 4423 3094
Fax
+98 51 4422 3594
Email
kfarzinfar@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pezhvak Rehabilitation Center
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kazem Farzinfar
Position
Visiting professor at Sabzevar Azad University and Payame Noor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ebne Yamin Street - Corner of Ebne Yamin 40
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613887575
Phone
+98 51 4423 3094
Fax
+98 51 4422 3594
Email
kfarzinfar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Nejat
Position
Faculty member of Quchan Azad University
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebne Yamin Street - Corner of Ebne Yamin 40
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613887575
Phone
+98 51 4423 3094
Fax
+98 51 4422 3594
Email
Hnejat54@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kazem Farzinfar
Position
Visiting Professor of Azad University and Payame Noor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Golshan 6
City
Sabzevar
Province
Razavi Khorasan
Postal code
9671643316
Phone
+98 51 4423 3094
Fax
+98 51 4422 3594
Email
kfarzinfar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Part of the participants' personal data in an unrecognizable way related to the main outcome
- Informing the study protocol (schema therapy and integrated cognitive-speech approach) in group therapy
- Publication of comparison results of analysis and statistical analysis of the study
- Informally scan the consent form and share it in the group.
- The clinical study report should be provided to the subject based on the conclusions and findings.
When the data will become available and for how long
After the end of the research
To whom data/document is available
public
Under which criteria data/document could be used
With payment terms and in order to research and increase knowledge
From where data/document is obtainable
Neishabour Azad University
What processes are involved for a request to access data/document
Login to Neishabour Azad University - Thesis Portal - Department of Psychology - Research Name