Effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms, Fear of Negative and Positive Evaluation in Individuals with Social Anxiety Disorder: Single Subject Design
The aim of this research is to investigate the effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms and Fear of Negative and Positive Evaluation of Social Anxiety Disorder.
Design
The Single Subject design included 12 individuals with Social Anxiety Disorder
Settings and conduct
This research will be done in Mashhad city. Variables are measured one week before the start of treatment and at the baseline stage. Subjects will then undergo the Contextual Schema Therapy for 16 one-hour weekly sessions. During treatment, the variables will be measured four times. Finally, the measurement of variables will be repeated at the end of treatment and then with a 3-month follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of Social Anxiety Disorder based on Structured Clinical Interview for DSM-5, Age range 20 to 30 years, Level of education: minimum Diploma and Consent of participants to attend treatment sessions.
Exclusion criteria: psychiatric disorders and comorbid disorders, addictive behaviors, medical disorders, concurrent psychological interventions.
Intervention groups
Contextual Schema Therapy: psychological education about the Contextual Schema Therapy model. Addressing the coping modes. Using the chair technique to access the child modes and critical modes, strengthen the healthy adult mode using Acceptance and Commitment Therapy (ACT) and Mindfulness techniques, the Imagery exercises, and reparenting techniques, learning to use the Schema-Mode flashcard, developing the behavioral experiments to solve behavioral problems.
Main outcome variables
Emotion Regulation; Interpersonal Problems; Painful Physical Symptoms and Fear of Negative and Positive evaluation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211006052690N1
Registration date:2021-10-26, 1400/08/04
Registration timing:registered_while_recruiting
Last update:2021-10-26, 1400/08/04
Update count:0
Registration date
2021-10-26, 1400/08/04
Registrant information
Name
Zahra Emam zamani
Name of organization / entity
The University of Semnan
Country
Iran (Islamic Republic of)
Phone
+98 51 3604 4025
Email address
zahra__emamzamani@semnan.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-19, 1400/07/27
Expected recruitment end date
2021-11-18, 1400/08/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms, Fear of Negative and Positive Evaluation in Individuals with Social Anxiety Disorder: Single Subject Design
Public title
Effectiveness of Contextual Schema Therapy on Emotion Regulation, Interpersonal Problems, Painful Physical Symptoms, Fear of Negative and Positive Evaluation in Individuals with Social Anxiety Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Social Anxiety Disorder based on Structured Clinical Interview for DSM-5 (SCID-5)
Age range 20 to 30 Years
Level of education, minimum diploma
Consent of the participants to attend the treatment sessions
Exclusion criteria:
Psychiatric disorders such as psychotic disorders and personality disorders and comorbid disorders such as other anxiety disorders, mood disorders, body dysmorphic disorder and substance use disorders
Addictive behaviors such as Internet Addiction (measured in the context of the interview)
Medical disorders (assessment by reviewing the file and medical history)
Receiving simultaneous psychological interventions
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences and Health Services., Basij Blvd., Semnan., Semnan province.
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2021-08-24, 1400/06/02
Ethics committee reference number
IR.SEMUMS.REC.1400.128
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Emotion regulation score in the Emotion Regulation Questionnaire (ERQ)
Timepoint
The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated.
Method of measurement
Emotion Regulation Questionnaire (ERQ)
2
Description
Interpersonal Problems score in the Inventory of Interpersonal Problems (IIP-32)
Timepoint
The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated.
Method of measurement
Inventory of Interpersonal Problems (IIP-32)
3
Description
Score of Painful Physical Symptoms in the Visual Analogue Scale (VAS)
Timepoint
The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated.
Method of measurement
Visual Analogue Scale (VAS)
4
Description
Fear of Negative Evaluation score in the Brief Fear of Negative Evaluation-II (BFNE-II)
Timepoint
The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated.
Method of measurement
Brief Fear of Negative Evaluation-II (BFNE-II)
5
Description
Fear of Positive Evaluation score on the Fear of Positive Evaluation Scale (FPES)
Timepoint
The variable will be assessed one week before the start of treatment and at the baseline stage. It will then be assessed four times during treatment. At the end of treatment and then with a 3 months follow-up, the assessment will be repeated.
Method of measurement
Fear of Positive Evaluation Scale (FPES)
Secondary outcomes
empty
Intervention groups
1
Description
Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Contextual Schema Therapy will be performed on the subjects in the form of the Single Subject Design for 16 sessions of 1 hour per week. Pharmacological intervention will not be used in this research. The treatment protocol is based on the book "Contextual Schema Therapy; An Integrative Approach to Personality Disorders, Emotional Dysregulation, and Interpersonal Functioning." The authors of this book are Eckhard Roediger, Bruce A. Stevens and Robert Brockman. Contextual Schema Therapy interweaves conceptual underpinnings of Schema Therapy with cuttingedge theoretical advances, contextualizing it within the framework of Second and Third Wave psychotherapy approaches.This model integrates the important concepts of Third Wave approaches such as Mentalization, Mindfulness, Acceptance, Metacognition, and human values into the basic Schema Therapy model. Contextual Schema Therapy uses the Third Wave therapeutic approaches to break through detachment; to confront harmful internal messengers; and to access and protect Vulnerable Modes, while strengthening the Healthy Adult Mode in order to thwart self-defeating patterns in favor of healthier responses. Therefore, the reason for naming this model as Contextual Schema Therapy is that it has been revised in light of contemporary contributions and understandings from Third Wave therapies. Sessions 1 to 3: Establishing the therapeutic relationship- Assessment- Preparing the problem list- Conceptualizing according to the Schema Therapy approach- Providing psychological education about the Contextual Schema Therapy model (Early Maladaptive Schemas, how they are formed and their continuation, explanation about the Modes and the Mode Model)- Providing an explanation of the descriptive diagram of the subject's modes and the Dimensional Mode Map. Sessions 4 to 6: Dealing with the Coping Modes, including identifying and labeling them, examining their advantages and disadvantages in the past and present (for Avoidant Coping Modes: reviewing the history and functional analysis of these Modes- for Submissive Coping Mode: using empathetic confrontation to access constructive anger- for Overcompensatory Coping Modes: highlighting the need for attachment). Using the Chair technique to bypass the Coping Modes and thus access to the Child Modes and Critical Modes- Identifying and meet the needs of the Child Modes- Identifying the Inner Critical Mode beliefs and addressing them through the Acceptance and Commitment approach: identifying and translating them into Second person and creating inconsistency, putting them on a chair, examining the negative effects of these beliefs on the person, using metaphors to defuse these beliefs and increasing the focus on the present- Strengthening the Healthy Adult Mode: using ACT and Mindfulness Techniques (such as Mindfulness of Breath Meditation, the 5–4–3 exercise, the Emotion Surfing, Self-Compassion exercise and The Eightieth Birthday imagery exercise to identify values)- Planning to do these exercises in the interval between sessions. Teaching how to complete the Mode Monitoring Form. Sessions 7 to 10: Presenting the logic of the Experiential techniques and Imagery Exercises– Imaging the important life events- Re-parenting and re-framing the events- if necessary, use the Chair technique to bypass the Coping Modes, Identifying and meet Needs of the Child Modes- Developing behavioral solutions for the interval between sessions- Preparing an audio file of Imagery exercises to listen to them 1-2 times in the interval between sessions. Sessions 11-13: Increasing the performance of the Healthy Adult Mode through the Two-Chair technique and creating a dialogue between the Healthy Adult Mode and Inner Critic Mode- Teaching the use of Schema-Mode flash cards and preparing a daily conversation notebook to write down the negative beliefs of the Inner Critic Mode and Adult Healthy Mode responses to them. Sessions 14 to 16: Preparing a list of behavioral problems- Developing the Behavioral Experiment and practice in the session in two ways: the Future-directed Imagery to plan behavior and fill out the form of behavioral activation or role-playing- Summarizing tips- helping to consolidate what has been learned through talking about obstacles and setbacks- Talking about ending treatment and expressing feelings about it.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ferdowsi University of Mashhad
Full name of responsible person
Dr. Mohammad Kafi
Street address
Ferdowsi University of Mashhad., Azadi Square., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2000
Email
pr@um.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Ferdowsi University of Mashhad
Full name of responsible person
Dr. Mohammad Kafi
Street address
Ferdowsi University of Mashhad., Azadi Square., Mashhad., Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۹۴۸۹۷۴
Phone
+98 51 3880 2000
Email
pr@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Ferdowsi University of Mashhad
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
The Semnan University
Full name of responsible person
Dr. Masoud Nasiri Zarandi
Street address
Campus No. 1, Central Organization of Semnan University., In front of Sokan Park., Semnan., Iran
City
Semnan
Province
Semnan
Postal code
3513119111
Phone
+98 23 3153 0000
Email
pr@semnan.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Semnan University
Proportion provided by this source
50
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
The Semnan University
Full name of responsible person
Dr. Issac Rahimian Boogar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology., Faculty of Psychology and Educational Sciences., Semnan University., Mahdishahr, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+982333623300- +982333624250
Email
i_rahimian@semnan.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Semnan University
Full name of responsible person
Dr. Issac Rahimian Boogar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology., Faculty of Psychology and Educational Sciences., Semnan University., Mahdishahr, Semnan, Iran.
City
Semnan
Province
Semnan
Postal code
3564111556
Phone
+982333623300- +982333624250
Email
i_rahimian@semnan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University
Full name of responsible person
Zahra Emam zamani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, Alley No. 17, Faramarz Abbasi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9186863568
Phone
+98 51 3604 4025
Fax
Email
zahra__emamzamani@semnan.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
This data may be misused by individuals and reported as data from other research.
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
Undecided - It is not yet known if there will be a plan to make this available
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
Only the part of the original outcome data can be shared.
When the data will become available and for how long
Access starts after printing the results.
To whom data/document is available
Students, Specialists and Professors of Psychology
Under which criteria data/document could be used
For Study Only
From where data/document is obtainable
Email: zahra_emamzamani@yahoo.com
What processes are involved for a request to access data/document
Give an email and state the reason for their request.