The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder.
Determining The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder.
Design
This randomized, single-blind, parallel-group trial will include 23 patients in the intervention group and 23 in the control/waitlist group, with allocation determined using Excel’s RAND function.
Settings and conduct
The Emotion Regulation Therapy (ERT) protocol developed by Mennin will be individually administered in 16 sessions to patients with Social Anxiety Disorder at Dr. Beheshti Psychiatric Hospital in Zanjan. Assessments will be conducted by an independent evaluator blinded to group allocation.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diagnosis of Social Anxiety Disorder via SCID-I/II; LSAS score ≥55; age 18–60; high school diploma or higher and signed informed consent.
Exclusion Criteria: Substance/alcohol use in the past 3 months; prior ERT for SAD; current psychiatric medication use or diagnosis of depressive, bipolar, psychotic spectrum, autism spectrum, or personality disorders per SCID-I/II.
Intervention groups
The intervention group will receive Mennin’s Emotion Regulation Therapy (ERT) with assessments at three phases, while the control group will undergo the same assessments without treatment. After the study, the control group will be offered ERT.
Main outcome variables
Severity of Social Anxiety Disorder symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250715066505N1
Registration date:2025-09-01, 1404/06/10
Registration timing:prospective
Last update:2025-09-01, 1404/06/10
Update count:0
Registration date
2025-09-01, 1404/06/10
Registrant information
Name
Reyhaneh Miralikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 1807
Email address
reyhaneh.miralikhani@sina.zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-06, 1404/06/15
Expected recruitment end date
2025-09-23, 1404/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder.
Public title
The effectiveness of Emotion Regulation Therapy on reducing the severity of symptoms and certain emotional and cognitive components in individuals with Social Anxiety Disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of symptoms consistent with Social Anxiety Disorder as determined by the Structured Clinical Interview for DSM-IV Axis I and II Disorders (SCID-I and SCID-II), and a minimum score of 55 on the Liebowitz Social Anxiety Scale (LSAS)
Possession of a high school diploma or higher level of formal education
Age range between 18 and 60 years
Willingness of participants to take part in the study as indicated by the provisions of the written informed consent
Exclusion criteria:
Diagnosis of depressive disorders, bipolar disorder, psychotic spectrum disorders, autism spectrum disorders, or personality disorders
Previous participation in formal emotion regulation clinical trials for Social Anxiety Disorder (SAD)
Current psychiatric medication use
Substance or alcohol use within the past three months
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be performed using Microsoft Excel. To do this, in the first column, 20 number “1” entries and 20 number “2” entries (representing the experimental and control groups, respectively) will be entered. Then, in the second column, 40 random numbers will be generated using the RAND function. The data will be sorted based on the values in the random number column (either in ascending or descending order). Through this sorting, the sequence of 1s and 2s will also be rearranged randomly. According to the new order of 1s and 2s, the participants will be assigned to the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the implementation of this study, blinding will be done in such a way that the therapist and the evaluator are two different people, the therapist is the student, and the evaluator will be a clinical psychology graduate who will not know about the people of both groups in the process of evaluating the occurrence of consequences and reduction of symptoms before and after treatment and also during the follow-up period.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
1st Floor, Building No. 1, Zanjan University of Medical Sciences and Health Services, Beginning of Jomhouri Eslami Street, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2025-05-26, 1404/03/05
Ethics committee reference number
IR.ZUMS.REC.1404.070
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
Severity of Social Anxiety Disorder symptoms
Timepoint
Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Liebowitz Social Anxiety Scale
Secondary outcomes
1
Description
Negative Mood Regulation Expectancies
Timepoint
Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention
Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Difficulties In Emotion Regulation Scale (DERS)
3
Description
Post Event Processing
Timepoint
Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention
Method of measurement
Post Event Processing Questionnaire (PEPQ)
Intervention groups
1
Description
Intervention group: Intervention group: This group will consist of 23 patients diagnosed with Social Anxiety Disorder who will receive Mennin’s Emotion Regulation Therapy (ERT) protocol twice weekly for a total of 16 sessions, each lasting 60–90 minutes. Assessments will be conducted at baseline, post-treatment, and three months after treatment completion. ERT is a third-wave, emotion-focused cognitive-behavioral therapy with a structured, stage-based format aimed at enhancing emotional awareness, developing regulation skills, and employing newly learned contextual strategies.
Category
Treatment - Other
2
Description
Control group: This group will include 23 patients with Social Anxiety Disorder who will receive no intervention during the study period and will be placed on a waitlist. After the study concludes, they will be offered Mennin’s Emotion Regulation Therapy (ERT) protocol, delivered twice weekly for 16 sessions of 60–90 minutes each.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Beheshti Psychiatric Hospital
Full name of responsible person
Seyede Elnaz Mousavi
Street address
Dr. Beheshti Psychiatric Hospital, Ark Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
libbeheshti@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mehrdad Hamidi
Street address
1st Floor, Building No. 1, Zanjan University of Medical Sciences and Health Services, Beginning of Jomhouri Eslami Street, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3315 6141
Fax
+98 24 3342 0460
Email
hamidim@zums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyede Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
elnaz48.mousavi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyede Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
elnaz48.mousavi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Seyede Elnaz Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
elnaz48.mousavi@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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