Protocol summary

Summary
The purpose of this study is comparison of the effect of transdiagnostic group therapy with cognitive group therapy in deduction of university students’ symptoms of adjustment disorder, depression and anxiety and promoting their happiness and quality of life with primary diagnosis of adjustment disorder. Global plan of this study is pre-test post-test with control group (cognitive group therapy as a standard treatment). The population is university students with adjustment disorder and the sample of it, is 30 university students with this kind of diagnosis (15 people in experimental group or transdiagnostic group and 15 people in control group or cognitive group). Inclusion criterion: having adjustment disorder diagnosis with depressed mood and anxiety symptoms (scores in depression and anxiety should be more than the cut of the inventories). Exclusion criteria: other diagnosis of axis I such as grief, MDD, psychosis, PTSD; drug abuse; giving another psychological treatment or using psychiatric drugs and physical defects. Transdiagnostic group therapy should be 9 sessions (each session is 2 hours in a week) and cognitive group therapy should be 10 sessions (each session is 2 hours in a week). The expected conclusion is deduction of adjustment symptoms and promoting of life quality and happiness.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012102211206N1
Registration date: 2013-07-05, 1392/04/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Saeedeh Zenoozian
Name of organization / entity
Tehran Psychiatry Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 1668
Email address
s-zenoozian@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of transdiagnostic group therapy with cognitive group therapy in deduction of university students symptoms of adjustment disorder and promoting their happiness and quality of life with primary diagnosis of adjustment disorder
Public title
Effect of transdiagnostic group therapy and cognitive group therapy in deduction of university students symptoms of adjustment disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: having adjustment disorder diagnosis with depressed mood and anxiety symptoms( scores in depression and anxiety should be more than the cut of the inventories). Exclusion criteria: other diagnosis of axis I such as grief, MDD, psychosis, PTSD; drug abuse; giving another psychological treatment or using psychiatric drugs and physical defects.
Age
From 18 years old to 40 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
Mental Health Research Center,Tehran University of Medical Sciences
Street address
tehran psychiatry institute- mansouri street--niayesh street-sattarkhan-Tehran-Iran
City
tehran
Postal code
1445613111
Approval date
2013-02-23, 1391/12/05
Ethics committee reference number
3078

Health conditions studied

1

Description of health condition studied
Adjustment disorders
ICD-10 code
F43.2
ICD-10 code description
Adjustment disorders

Primary outcomes

1

Description
Adjustment disorder symptoms
Timepoint
Before intervention and after intervention
Method of measurement
Structured clinical interview for DSM-IV

2

Description
Depression
Timepoint
Before intervention and after intervention
Method of measurement
Beck depression inventory

3

Description
Anxiety
Timepoint
Before intervention and after intervention
Method of measurement
Beck anxiety inventory

4

Description
General function
Timepoint
Before intervention and after intervention
Method of measurement
Work and social adjustment scale

5

Description
Happiness
Timepoint
Before intervention and after intervention
Method of measurement
Oxford happiness interview

6

Description
Quality of life
Timepoint
Before intervention and after intervention
Method of measurement
World health organization quality of life-BREEF

Secondary outcomes

empty

Intervention groups

1

Description
Experimental group with 15 members will receive transdignostic treatment for 9 weekly sessions( each session will be 2 hours). At the last session the group members should complete the inventories again as post-test.
Category
Behavior

2

Description
The control group with 15 members will receive cognitive group therapy for 10 sessions( each session is 2 hours). At the last session they should complete the inventories again as post-test. the members can be absent just for 2 sessions and more than it is not acceptable and they will be dropped out of therapy.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Councelling center of Sanaati Sharif University
Full name of responsible person
Saeedeh Zenoozian
Street address
Councelling center- Sharif university-Azadi street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Rasul Farasat Kish
Street address
Second floor- Central building- Iran University of Medical Sciences-next tomilad tower-shahid hemmat autoban-Tehran- Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Tehran Psychiatry Institute
Full name of responsible person
Saeedeh Zenoozian
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
number 1-mansuri street- niayesh street-sattarkhan-tehran- Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6655 1668
Fax
Email
zenoozian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Psychiatry Institute
Full name of responsible person
Saeedeh Zenoozian
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
number 1-mansuri street- niayesh street-sattarkhan-tehran- Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6655 1668
Fax
Email
zenoozian2yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran Psychiarty Institute
Full name of responsible person
Saeedeh Zenoozian
Position
PhD student of clinical psychology
Other areas of specialty/work
Street address
number 1-mansuri street- niayesh street-sattarkhan-tehran- Iran
City
Tehran
Postal code
1445613111
Phone
+98 21 6655 1668
Fax
Email
zenoozian@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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