Protocol summary

Summary
objective: the aim of this study was compare of schema therapy and group cognitive therapy to reduce depression, anxiety and perceived stress women with high-risk behavior patrons. design: This quasi-experimental study with single-stage cluster sampling method. The population of 500 individuals attending women with a history of sexual risk behavior for HIV testing that went to the center of the age range 20 to 60 years and have a diploma to high levels by psychology and medicine diagnostic interview, the use of formula sample of 250 randomly selected and depression, anxiety, stress was conducted. 85 clients of depression, anxiety, stress were detected, of which 45 people were selected randomly in three groups of 15 people, including two experimental groups and one control group patients: included women with a history of sexual risk behavior and Exclusive criteria, having no sexual risk behavior in their history . setting and conduct: 12 sessions of cognitive therapy and 12 sessions schema therapy was conducted at the time of each session was 90 minutes. At the end of the training period, all groups are re-test. intervention and main out come: The results showed that schema therapy than in cognitive therapy on depression, anxiety and perceived stress female clients with high-risk behavior is more effective.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012121911782N2
Registration date: 2016-04-30, 1395/02/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-30, 1395/02/11
Registrant information
Name
Akbar Hemmati Sabet
Name of organization / entity
Department of counseling, Science and Research branch, Islamic Azad University, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 81 1254 2814
Email address
mohamad.hemmati1363@yahoo.com
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of effectiveness schema therapy and group cognitive therapy to reduce depression, anxiety and perceived stress women
Public title
Compare of effectiveness psychological intervention to women,s psychological signs
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: included women with a history of sexual risk behavior for HIV testing that went to the center of the age range 20 to 60 years and have a diploma to high levels by psychology and medicine diagnostic interviewed that they have sign of depression, anxiety and stress. Exclusion criteria: having no sexual risk behavior in their history.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 500
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committe of Hamadan University of Medical Sciences
Street address
hamadan felestin square
City
hamadan
Postal code
319
Approval date
2005-12-30, 1384/10/09
Ethics committee reference number
11047/32/16/پ

Health conditions studied

1

Description of health condition studied
depression disorder
ICD-10 code
F33.0, F33
ICD-10 code description
Recurrent depressive disorder, unspecified

2

Description of health condition studied
anxiety disorder
ICD-10 code
F41.1, F41
ICD-10 code description
Anxiety disorder, unspecified

3

Description of health condition studied
Stress
ICD-10 code
F43.0, F43
ICD-10 code description
Other reactions to severe stress

Primary outcomes

1

Description
stress
Timepoint
a month before post test and a week after pretest
Method of measurement
anxiety and depression, anxiety, stress scale (DASS, Lovibond, P.F. Lovibond, 1995)

2

Description
depression
Timepoint
post test and pretest
Method of measurement
anxiety and depression, anxiety, stress scale (DASS, Lovibond, P.F. Lovibond, 1995)

3

Description
anxiety
Timepoint
post test and pretest
Method of measurement
anxiety and depression, anxiety, stress scale (DASS, Lovibond, P.F. Lovibond, 1995)

Secondary outcomes

empty

Intervention groups

1

Description
12 sessions schema therapy and time of each session was 90 minutes
Category
Behavior

2

Description
12 sessions of cognitive therapy and time of each session was 90 minutes.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
shohada hospital
Full name of responsible person
Dr mina nikhbakht
Street address
hamadan, takhti street
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Science and Research branch Islamic Azad University Tehran
Full name of responsible person
Akbar hemmati sabe
Street address
hamadan
City
hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Science and Research branch Islamic Azad University Tehran
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
Department of counseling, Science and Research branch, Islamic Azad University, Tehran, Iran
Full name of responsible person
akbar hemmati sabet
Position
phd student
Other areas of specialty/work
Street address
hamadan
City
hamadan
Postal code
Phone
+98 83 1254 2814
Fax
Email
mohamad.hemmati1363@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Professor ,phD in Counseling , Kharazmi University ,Tehran
Full name of responsible person
Shokooh Navabi Nejad
Position
phd of counseling
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
+98 83 1254 2814
Fax
Email
Navabinejad93@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of counseling, Science and Research branch, Islamic Azad University, Tehran, Iran.
Full name of responsible person
akbar hemmati sabet
Position
Other areas of specialty/work
Street address
Ph.d student
City
hamadan
Postal code
Phone
+98 83 1254 2814
Fax
Email
mohamad.hemmati1363@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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