Effectiveness of Group Behavioral Activation Therapy; Drug Therapy and Combination Therapy on Clinical Signs (Anxiety and Depression), Negative Evaluation and Quality of Life in Patients with Social Anxiety Disorder
This research studies the efficacy of group behavioral activation therapy and drug therapy and combined therapy on anxiety and depression, negative evaluation, and quality of life in patients with social anxiety disorder.
Design
In this study, in the specialty psychology center (2018-2017) 41 of these patients were randomly selected in volunteers. The instruments for measuring the variables of the research, including the Spin Social Anxiety Scale (2000), Depression Beck-2, the World Health Organization's Short Quality of Life Scale (1989), and the Consequences of the Wilson & Rapper Social Negative Events (2005)
Settings and conduct
Specialist Consulting and Psychotherapy Center
Participants/Inclusion and exclusion criteria
Entry criteria: Social Anxiety Disorder, residency in Mashhad, Degree higher than diploma , age between 18 to 40 years old
Exit criteria: Specific Axis 1 Disorder, under the psychological or Medical treatment at the same time as research, disabling physical illness that it s possibile to make problem for group research.
" Social anxiety "
" depression "
" fear of negative evaluation "
" quality of life "
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038109N3
Registration date:2018-07-10, 1397/04/19
Registration timing:retrospective
Last update:2018-07-10, 1397/04/19
Update count:0
Registration date
2018-07-10, 1397/04/19
Registrant information
Name
Mahdi Amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3869 1438
Email address
amirime@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-30, 1396/11/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
2018-05-11, 1397/02/21
Actual recruitment end date
2018-06-11, 1397/03/21
Trial completion date
empty
Scientific title
Effectiveness of Group Behavioral Activation Therapy; Drug Therapy and Combination Therapy on Clinical Signs (Anxiety and Depression), Negative Evaluation and Quality of Life in Patients with Social Anxiety Disorder
Public title
"Evaluating Effectiveness of Group Behavioral Activation Therapy;Drug Therapy and Combined Therapy on Social Anxiety Disorder"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Social anxiety disorder based on diagnostic interview ( DSM-V )
Residence in Mashhad at the time of meeting group therapy
Degree higher than diploma
age between 18 to 40 years old
Exclusion criteria:
Having a specific axis of disorder by using a structured interview for DSM-V mental disorders
Having a disabling physical illness that,it is possibile to make problem for group research
Being under the psychological or Medical treatment at the same time as research
Age
From 18 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
48
Actual sample size reached:
41
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected in a targeted manner with a Diagnostic Interview according to DSM-V criteria and Spin Anxiety questionnaire score and randomly selected by two-way blind lottery in groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the researcher did not know the division of the members into the groups and the participants were assigned to groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ebnesina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9319797139
Approval date
2018-04-10, 1397/01/21
Ethics committee reference number
IR.MUMS.fm.REC.1396.489
Health conditions studied
1
Description of health condition studied
Social Anxiety Disorder
ICD-10 code
F93.2
ICD-10 code description
Social anxiety disorder of childhood
Primary outcomes
1
Description
Social Anxiety Scale with Spin Questionnaire
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Spin Social Anxiety Scale (2000)
2
Description
Depression Scale with Beck Questionnaire
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Beck Depression Inventory
3
Description
Fear of Negative Assessment with Wilson & Rappi's Consequences of Social Incidents (2005)
Timepoint
Pre-test, post-test, follow-up
Method of measurement
Wilson & Rappi's Consequences of Social Incidents (2005)
4
Description
Quality of Life Score with the World Health Organization Short Life Style Quality Scale (1989)
Timepoint
Pre-test - Post-test - Follow up
Method of measurement
World Health Organization Quality of Life Scale (1989)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Combined behavioral group activation therapy by taking placebo: The behavioral group therapy trend in group sessions were held for the experimental group based on Menal Guelan, during of sessions, which the basic principles of behavioral activation, the recording of their daily activities program within a week, And its application in the face of avoiding enjoyable and mastering activities and And tabulating these activities and assessing skills, choosing, examining, joining, observing results, never give up too. Also, motivation skills, responsiveness, appropriate alternatives, coping methods and overcome stimuli, responses, avoidance patterns, self-esteem skills, self-expression, and courageous training and discussion.
Category
Treatment - Other
2
Description
Intervention group: Group supportive treatment with paroxetine. Each of the participants in the drug treatment group took paroxetine seven times a week. According to psychiatrist, for avoiding side effects, three to four days in the first week, they took half a dozen paroxetine at night. Also, throughout the course of treatment, the contact numbers were given to the participants to contact and notify in case of possible side effects. Except for drowsiness in the first nights of taking medication, no particular complications were reported. were reported.
Category
Treatment - Drugs
3
Description
Intervention group: Combined behavioral group activation therapy with paroxetine. In combined group therapy, behavioral activation therapy was performed according to the behavioral activation group therapy guidelines that described in the behavioral therapy intervention, simultaneously with the treatment of a daily dose of paroxetine.
Category
Treatment - Other
4
Description
Control group: Waiting list
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Adora Specialist Consulting and Psychotherapy Center, Mashhad
Full name of responsible person
Dr. Farnaz Abharzanjani
Street address
No. 111, between Janbaz Ave and Samaneh Ave; Ferdowsi Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3766 6805
Email
farnaz.zanjani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Saeed Eslami
Street address
University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
amiri.psy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mahdi Amiri
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebnesina Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
amiri.psy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Elham Taheri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebnesina Haspital
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3700 2317
Email
elhamtaheri85@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Farnaz Abharzanjani
Position
Teacher of law
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ebnesina Hospital Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
0938131877
Phone
+98 51 3869 1438
Email
farnaz.zanjani@yahoo.com
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
The information of the clients is confidential and its controversy with secrecy in the context of psychotherapy is contradictory