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The Effectiveness of Schema Therapy on Reducing Signs of people with Chronic Panic Disorder: Case study

Protocol summary

Study aim
Determining the effectiveness of Schema therapy on reducing fear of physical concerns, fear of lack of cognitive control, fear of being observed by others, overall health concerns, fear of disease and fear of disease consequence in people with chronic Panic disorder Determination of primary maladaptive Schemas in people with chronic Panic disorder
Design
case study, semi-experimental, in the form of multiple baseline, have 2 samples and are available by sampling, Interventions in 17 sessions, each session lasts 90 minutes. study protocol is provided by Jeffrey Young.
Settings and conduct
Structured clinical interview to diagnose panic disorder; Assessing the suitability for receiving schema therapy; pre-exam; Assessment in order to Case conceptualization, cognitive techniques; Experimental techniques; behavioural pattern-breaking techniques; Relationship therapy techniques; Execution of questionnaires during and after interventions; Location of Psychological Counseling Center of Ilam Welfare Organization
Participants/Inclusion and exclusion criteria
Inclusion criteria: An initial diagnosis of panic disorder؛ Psychiatric interview to diagnose panic disorder؛ Chronic disorder for at least a year؛ Age over 18 years and under 40 years؛ Similarity of drugs used by patients؛ Minimum level of education: third grade middle school Exclusion criteria: Severe mental disorders, including bipolar disorder and severe depression Drug abuse Concurrent treatment by another psychologist Patients who have no psychological mind
Intervention groups
2 people with chronic panic disorder receive 17 sessions each lasting 90 minutes schema therapy. In sessions 1, 5, 9, 13, 17, and one month after the last session, questionnaires are administered. People will be compared to themselves.
Main outcome variables
Fear of physical worries, fear of not having cognitive control, fear of anxiety to be seen

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200216046515N1
Registration date: 2020-07-18, 1399/04/28
Registration timing: retrospective

Last update: 2020-07-18, 1399/04/28
Update count: 0
Registration date
2020-07-18, 1399/04/28
Registrant information
Name
Bahareh Farokhi
Name of organization / entity
Allameh Tabataba'i University
Country
Iran (Islamic Republic of)
Phone
+98 21 8880 4058
Email address
b_farokhi@atu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-13, 1399/03/24
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Schema Therapy on Reducing Signs of people with Chronic Panic Disorder: Case study
Public title
The Effectiveness of Schema Therapy on Treatment of Chronic Panic Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
An initial diagnosis of Panic disorder Psychiatric interview to diagnose Panic disorder Chronic Panic disorder for at least a year Age over 18 years and under 40 years The similarity of the Drugs used by Patients Fluency in Persian Minimum level of education: third grade middle school
Exclusion criteria:
Severe mental disorders, including bipolar disorder and severe depression Drug abuse Concurrent treatment by another psychologist Patients who have poorly reported Successful treatment in evaluation or have no psychological mind
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 2
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
National Ethics Committee in Biomedical Research, Allameh Tabatabai University
Street address
SIXTH alley, MALEKOSHOARA street, SAYAD SHIRAZI boulevard, JANBAZAN neighborhood, ILAM city
City
Tehran
Province
Tehran
Postal code
6931174838
Approval date
2020-02-01, 1398/11/12
Ethics committee reference number
IR.ATU.REC.1398.016

Health conditions studied

1

Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder

Primary outcomes

1

Description
Variable scores; Fear of physical worries, fear of not having cognitive control, fear of anxiety to be seen
Timepoint
Sessions 1, 5, 9, 13, 17 and one month after the last session
Method of measurement
Floyd et al. 2005 Anxiety Sensitivity Questionnaire

Secondary outcomes

1

Description
Variable scores; General health concerns, fear of disease, fear of disease consequences
Timepoint
Sessions 1, 5, 9, 13, 17 and one month after the last session
Method of measurement
Health Anxiety Questionnaire Salkowski et al. 2002 (short form 18 questions)

2

Description
Early maladaptive schemas scores
Timepoint
Sessions 1, 5, 9, 13, 17 and one month after the last session
Method of measurement
Young Schema Questionnaire (Short Form - Third Edition - 90 Questions)

Intervention groups

1

Description
Intervention; Structured clinical interview to diagnose panic disorder; Assessing the suitability for receiving schema therapy; pre-exam; Assessment in order to conceptualize the case; Cognitive techniques; Experimental techniques; behavioural pattern-breaking techniques; Relationship therapy techniques; Execution of questionnaires during and after interventions. Interventions are performed in 17 sessions, 90 minutes per session and one session per week. Studies have shown that the results of the drug recur after a significant proportion of patients (25-50% recorded during six months) (Mahmoudi, Naderi Rajeh and Masoudzadeh, 2016). Cognitive behavioral therapy is the first line of treatment for panic disorder (Heldt et al., 2003; cited in Wesner et al., 2019). But many patients have residual symptoms or partial response to treatment (Porter & Chamblless, 2015; Craske et al., 2017; quoting Wesner et al., 2019). Patients may fail during cognitive-behavioral therapy due to schema issues (Hoffart, 2017). Many patients with panic disorder are highly resistant to starting and continuing psychotherapy sessions. The reason for canceling treatment sessions, in addition to cost and disbelief in treatment, is ambiguity in treatment due to schema (Leahi, 2001, translated by Hamidpour, Anduz, and Zirak, 1396). Classical cognitive behavioral therapy has assumptions about patients that do not apply to patients with cognitive behavioral problems who have chronic, ambiguous, and pervasive problems (Young et al., 2003, translated by Hamidpour and Andouz, 2007). Research shows that focusing on schemas can be useful for patients with chronic emotional problems, including chronic anxiety (Keefe, Webb, & Derubeis, 2016). Schema therapy has never been used for patients with chronic panic disorder.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Hamidreza Karim's psychiatric office
Full name of responsible person
Dr. Hamidreza Karim
Street address
Dr. Hamidreza Karim's psychiatric office, Rashidi Alley, in front of Blood Transfusion Organization, South Saadi St., Saadi Crossroads, ILAM city6
City
ILAM
Province
Ilam
Postal code
6931613189
Phone
+98 84 3336 0988
Email
HRK1388@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Hamid Reza Olumi Yazdi
Street address
Allameh Tabatabai University, Central Building, Village Square, Olympic Village
City
Tehran
Province
Tehran
Postal code
۱۴۸۹۶۸۴۵۱۱
Phone
+98 21 4839 0000
Email
ict@atu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh Tabatabai University
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
Allameh Tabatabai University
Full name of responsible person
Bahareh farokhi
Position
Master student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
6th Alley, MALEKOSHOARA St., SAYADSHIRAZI Blvd., JANBAZAN neighborhood, ILAM city
City
ILAM
Province
Ilam
Postal code
6931174838
Phone
0098842244554
Email
Baharehfarokhi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Bahareh farokhi
Position
Master student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
6th Alley, MALEKOSHOARA St., SAYADSHIRAZI Blvd., JANBAZAN neighborhood, ILAM city
City
ILAM
Province
Ilam
Postal code
6931174838
Phone
0098842244554
Email
Baharehfarokhi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Allameh Tabatabai University
Full name of responsible person
Bahareh farokhi
Position
Master student of clinical psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
6th Alley, MALEKOSHOARA St., SAYADSHIRAZI Blvd., JANBAZAN neighborhood, ILAM city
City
ILAM
Province
Ilam
Postal code
6931174838
Phone
0098842244554
Email
Baharehfarokhi@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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Share data after making it unrecognizable
When the data will become available and for how long
Start access after printing results
To whom data/document is available
Researchers in the field of mental health
Under which criteria data/document could be used
To know the details of the study and the use of data in research studies
From where data/document is obtainable
Baharehfarokhi@yahoo.com , Dr. Faramarz Sohrabi Asmaroud, Fifth Floor, Faculty of Psychology and Educational Sciences, Allameh Tabatabai University
What processes are involved for a request to access data/document
Send your application by university email; It takes less than two weeks.
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