Protocol summary
-
Study aim
-
The evaluate the effectiveness of these three interventions on social anxiety disorder
-
Design
-
This study was a clinical trial with a single-case experimental study non-concurrent multiple baseline design
-
Settings and conduct
-
The interventions were performed individually by a clinical psychologist and assistant therapist in Shiva Psychology and Counseling Services Center located in Tehran, Tehran province.
-
Participants/Inclusion and exclusion criteria
-
The Inclusion criteria were the diagnosis of SAD, history of disorder for two years, age range 20-28 years, level of undergraduate and graduate education, etc.
The Exclusion criteria were Absence of more than two sessions, a history of psychotic or bipolar disorder, having substance or alcohol abuse etc.
-
Intervention groups
-
First intervention group: Act Matrix
The protocol on matrix of acceptance and commitment therapy was developed based on the agenda (Polk & et al, 2016) for social anxiety disorder by the first researcher.
Second intervention group: ACT Focused on Self– Compassion
The protocol on ACT Focused on Self– Compassion is based on the agenda (Hayes, 2005, 2008 & Gilbert, 2010, 2016) developed by Esmaeli (2018).
Third intervention group: CBT based on Hofmann's model
The protocol of cognitive-behavioral therapy based on Hoffmann model (2008) has been developed by Hoffmann and Otto.
-
Main outcome variables
-
Scores of Social anxiety, self-compassion, psychological flexibility of acceptance and valuable practice and life are the dependent variables of this study.
General information
-
Reason for update
-
Presentation of Research Results
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200816048424N1
Registration date:
2020-09-09, 1399/06/19
Registration timing:
registered_while_recruiting
Last update:
2021-11-07, 1400/08/16
Update count:
1
-
Registration date
-
2020-09-09, 1399/06/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-07-27, 1399/05/06
-
Expected recruitment end date
-
2021-01-04, 1399/10/15
-
Actual recruitment start date
-
2020-07-27, 1399/05/06
-
Actual recruitment end date
-
2021-01-04, 1399/10/15
-
Trial completion date
-
2021-01-04, 1399/10/15
-
Scientific title
-
Developing a Model of Integrative Act Matrix & comparison of its effectiveness with Acceptance and Commitment Therapy Focused on Self –Compassion & Cognitive-behavioral therapy based on Hofmann's model on Social Anxiety Disorder (Single-subject study with multiple baseline)
-
Public title
-
The effectiveness of Act Matrix, Act focused on compassion and hofmann's Cognitive-Behavioral Therapy on Social Anxiety Disorder
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Diagnosis of Social Anxiety Disorder
History of Disorder for Two Years
Age 20 to 28 Years
level of Undergraduate and Graduate Education
Satisfaction and Commitment to Participate in Research,
Not Participating in other Therapies at the same time
Exclusion criteria:
The Absence of more than two sessions
History of Psychotic or Bipolar Disorder throughout life
History of Schizoid and Avoidant Personality Disorders, Obsessive-Compulsive Disorder, Panic and Suicidal Ideation During the Last Six Months
having substance or alcohol abuse
-
Age
-
From 20 years old to 28 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
9
Actual sample size reached:
9
-
Randomization (investigator's opinion)
-
N/A
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The Subjects did not know which treatment group they belonged.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Single-Case Experimental Study whit Multiple Baseline Design
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-05-19, 1400/02/29
-
Ethics committee reference number
-
IR.IAU.SHIRAZ.REC.1400.010
Health conditions studied
1
-
Description of health condition studied
-
social anxiety disorder based on psychiatrist assessments (DSM-5)
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Scores of Social anxiety, self-compassion, psychological flexibility of acceptance and valuable practice and life are the dependent variables
-
Timepoint
-
Before the intervention, after the intervention, 2 months after the end of the intervention (follow-up).
-
Method of measurement
-
the Liebowitz Social Anxiety Scale (Heimberg, & et al,1999), the Acceptance and Practice Flexibility Questionnaire-Second Version (Bond, & et al 2011),the Self-Compassion-Short Form Scale (Raes, & et al, 2011), and the Life Questionnaire. Valuable (Wilson, & et al,2010) were used
Secondary outcomes
1
-
Description
-
There is no secondary outcome variable
-
Timepoint
-
Single-subject design with multiple baseline with repeated measurements
-
Method of measurement
-
The varyable were analyzed by visual mapping, recovery percentage, stable change index, and six clinical performance indices
Intervention groups
1
-
Description
-
First intervention group: Act MatrixThe protocol on matrix of acceptance and commitment therapy was developed based on the agenda (Polk & et al, 2016) for social anxiety disorder by the first researcher.
-
Category
-
Treatment - Other
2
-
Description
-
Second intervention group: ACT Focused on Self– Compassion The protocol on ACT Focused on Self– Compassion is based on the agenda (Hayes, 2005, 2008 & Gilbert, 2010, 2016) developed by Esmaeli (2018).
-
Category
-
Treatment - Other
3
-
Description
-
Third intervention group: CBT based on Hofmann's modelthe protocol of cognitive-behavioral therapy based on Hoffmann model (2008) has been developed by Hoffmann and Otto
-
Category
-
Treatment - Other
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Islamic Azad 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
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
-
Not applicable
-
Title and more details about the data/document
-
Completed questionnaires can be provided in the baseline, treatment and follow-up stages.
-
When the data will become available and for how long
-
Start accessing single-subject data when the article is fully printed
-
To whom data/document is available
-
Clinical researchers
-
Under which criteria data/document could be used
-
In order to verify the results
-
From where data/document is obtainable
-
Refer to the researcher's email (hamid asadi)
-
What processes are involved for a request to access data/document
-
After publishing the article and the introductory document, email the experimental plan of the single subject.
-
Comments
-