Comparison of Cognitive Behavioral Group therapy's Efficacy Versus Hypnotherapy on decreasing signs of social phobia and patients' brain/behavioral systems changes.
After volunteers sign up for participation in the study through a public invitation across all Zanjan universities and higher education institutes and also by referral of other psychiatrists and clinical psychologists they will be tested for social phobia and checked for inclusion and exclusion criteria through questionnaires and diagnostic interview. After that the participants will be assigned randomly in tow groups. Each group will receive a different treatment (Cognitive-behavioral group therapy and hypnotherapy). Both treatments will take place in a format of group therapy.
First group will receive 6 therapy sessions of CBGT and the protocol is derived from Morrise et al protocol at Dalhousie University of Canada. Second group will receive 4 therapy sessions of hypnotherapy which the protocol was made by the researcher and has the approval licence and supervision through the study from the Iranian Scientific Society of Clinical Hypnosis. Participants will be assessed in tow stage of pre-test and post-test by following questionnaire (DASS-21, SAD, SPIN, BAI, WHOQOL-BREF, GWPQ,FNES-B). At the end of treatment courses the data will be statistically analyzed and the results will be published by confidentiality concerns.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121425523N1
Registration date:2017-01-15, 1395/10/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-15, 1395/10/26
Registrant information
Name
Golnaz Forouzandehfar
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 0301
Email address
gforouzandehfar@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Cognitive Behavioral Group therapy's Efficacy Versus Hypnotherapy on decreasing signs of social phobia and patients' brain/behavioral systems changes.
Public title
Comparison of Cognitive Behavioral Group therapy's Efficacy Versus Hypnotherapy on decreasing signs of social phobia and patients' brain/behavioral systems changes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Having DSM-5 diagnostic criteria for social phobia
2.Getting psychiatric diagnosis of Social Phobia based on diagnostic interviews by Psychiatrist or Clinical Psychologist.
3. Subject's Score on SPIN questionnaire
4. Participants should not have received any treatments 6 month prior to beginning of the study.
5. participants should not received any medication one month prior to beginning of the study.
6. Participants should have a minimum age of 18 and maximum age of 50 years old.
7. Participants Should be at least on a undergraduate program.
8. Participants should agree to participation principals of the study and sign a written consent.
Exclusion criteria:
1. having a psychotic disorder and or substance abuse based on diagnostic interview.
2. having full criteria of personality disorder diagnosis on Axis II based on diagnostic interview.
3. Being absent for more than one session of therapy course.
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Jomhouri Eslami Blv, Azadi Squ, Zanjan, Iran
City
Zanjan
Postal code
Approval date
2016-05-04, 1395/02/15
Ethics committee reference number
IR.ZUMS.REC.1395.36
Health conditions studied
1
Description of health condition studied
Social phobia
ICD-10 code
F40.1
ICD-10 code description
Social phobias
Primary outcomes
1
Description
Social Phobia
Timepoint
Before intervention, after intervention, 1 month after intervention
Method of measurement
SPIN questionnaire
Secondary outcomes
1
Description
Depression
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
DASS-21 Questionnaire
2
Description
physiologic symptoms of Anxiety
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
BAI Questionnaire
3
Description
Anxiety
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
DASS-21 Questionnaire
4
Description
Avoidance Signs of Anxiety
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
SAD Questionnaire
5
Description
general function
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
GAF Scale
6
Description
quality of life
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
WHOQOL- BREF Questionnaire
7
Description
Brain/Behavioral System changes
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
GWPQ Questionnaire
8
Description
fear of negative evaluation
Timepoint
before intervention, after intervention, one month after intervention
Method of measurement
FNESB Questionnaire
Intervention groups
1
Description
Experimental Group 1:
Cognitive-behavioral group therapy for social phobia
Following Protocol is going to be used:
A Brief Cognitive-Behavioral Treatment for Social Anxiety Disorder
Eric P. Morris, David Mensink, and Sherry H. Stewart
Dalhousie University
Session 1: Following the questionnaires, introductions are made,An overview of the coming sessions is discussed and any questions were addressed,Feared Situations Questionnaire, developed by the authors, is administered, Discussion of Thoughts/Situations on the board. The board can be divided into two columns; on the left, the automatic thoughts are recorded, using examples from the class and on the right, the types of situations that elicit the thought, An introduction to how thoughts affect the subsequent physiological reactions and behaviors is presented on the board, Introduce the Vertical Arrow Technique on the board, Homework: Think about distorted thoughts you have during one anxiety provoking social situation that occurs between now and next session.
Session 2:
1) Review Homework, 2) The 10 Burns cognitive distortions are introduced, with the goal of providing the clients with examples of the types of thinking errors they were making,
3) Administer Feared Situations Questionnaire. This questionnaire was designed to provide the therapists with a better idea of which types of situations elicit the most social evaluative fear in the clients, 4) The Steps for Moderating Negative Feelings worksheet, developed by the authors, is administered, which explicitly outlines the process of identifying, analyzing, and correcting negative thoughts, Homework.
Session 3:
1) Discuss homework, 2) Continue developing automatic thoughts and replies on the board, 3) The concept of safety behaviors/cognitions is introduced with several examples provided by the therapist, Homework.
Session 4:
The purpose of this session is to talk about self esteem,To help the clients better understand the construct of self-esteem, several worksheets are administered.
Session 5 and 6:
Based on their responses from the feared situations questionnaire, a number of feared scenarios can be listed on a handout and administered to the group. This handout is given to the group to provide a few examples of the types of situations they could role play in the session.
Role plays are to be geared towards creating an anxiety provoking situation specific to the individual clients, Clients are randomly chosen to participate in a role play in front of the group, The role plays typically last approximately 10min with about 15min of preparation time, The Subjective Units of Distress (SUD) ratings are taken just prior to commencing the role play and are recorded on the board. SUD ratings are a simple tool used to provide a rough approximation of the client’s anxiety level. SUD ratings typically consist of a vertical line with “0” at the bottom and “100” at the top and clients are told that 100 is the most anxious they have been while 0 is the least anxious, Following the completion of the role play, the clients are asked about the automatic thoughts they experienced and whether they had applied any of their cognitive strategies to these thoughts. Feedback is also elicited from the group on the client’s performance (the feedback is typically positive and encouraging).
Category
Treatment - Other
2
Description
Experimental Group 2:
Group Hypnotherapy for social phobia
the following group will receive 4 sessions of hypnotherapy within 4 weeks and the protocol is self-structured and approved by The Iranian Scientific Society of Clinical Hypnosis.
session 1:
Administration of PMR (Progressive Muscle Relaxation) and Relaxation training, Records of the session will be given to participants for further practice as homework.
session 2:
recognition of primary symptoms, Imagery Inductions, records of session 1 and 2 will be given to participants for further practice.
session 3:
Emotional Modelling, cognitive reconstruction and behavior modification through mental visualization, conditioning, as homework records of session 1, 2 and 3 will be given to participants for further practice.
session 4:
repetition of the conditioning, repetition of 3rd session, answering participants questions, asking them for feedback.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical School, Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Forouzandehfar
Street address
Medical School, Zanjan University of Medical Sciences,Haj Ahmad Mahdavi st, Shahrak Karmandan, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohammad Masoud Vakili, PhD
Street address
Zanjan University of Medical Sciences, Jomhouri Slami blv, Azadi Squ, Zanjan, Iran.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Golnaz Forouzandehfar
Position
MSc Candidate of Clinical psychology
Other areas of specialty/work
Street address
Psychology Department, Dr.Beheshti Hospital, Saadi St, Zanjan, Iran