Protocol summary

Summary
Objectives: The purpose of this study was to investigate the efficacy of group metacognitive therapy in comparison with group life skills training on depression, metacognitive beliefs, rumination response styles, quality of life, clinical satisfaction and clinical global impressions in divorced female. Design: subjects were 24 people including 12 women considered as experimental group and 12 women assigned as control group. Setting and conduct: Twice of instruments were employed to collect data: Prior to the experiment, Beck Depression Inventory, World Health Quality of Life- BREF, Metacognations Questionnaires and Rumination Response Scale as well as Clinical Satisfaction Questionnaire and Clinical Global Impressions at the end of the study. Inclusion criteria: The subjects were chosen from those who did not receive any therapy at least from one month before the study; the patients were volunteers to participate; the minimum education level was sixth; between 18 and 50 years old. Exclusion criteria: Patients with other psychological disorders in I axis; psychotic symptoms; dependence and substance abuse. Intervention: The patients assigned to metacognitive therapy provided with treatment for 8 sessions and those in grouped life skill training provided with treatment for 8 sessions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013121115754N1
Registration date: 2014-02-06, 1392/11/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-02-06, 1392/11/17
Registrant information
Name
Zohreh Razavizadeh
Name of organization / entity
Islamic Azad University of Torbat jam
Country
Iran (Islamic Republic of)
Phone
+98 58 4225 1275
Email address
h.shareh@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Group Metacognitive Therapy and Group Training Life Skills in Depression, Metacognitive beliefs, Rumination Response Styles and Quality of Life in Divorced Female.
Public title
Comparison of Group Metacognitive Therapy and Group Training Life Skills in Depression, Metacognitive beliefs, Rumination Response Styles and Quality of Life in Divorced Female.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The subjects were chosen from those who did not receive any therapy at least from one month before the study; the patients were volunteers to participate; the minimum education level was sixth; between 18 and 50 years old. Exclusion criteria: Patients with other psychological disorders in I axis; psychotic symptoms; dependence and substance abuse.
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 24
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
Moral Committee of Islamic Azad University of Torbate jam.
Street address
7 km to Torbat jam, Mashhad road.
City
Torbate jam
Postal code
957719-9
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
11820701911001

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
f32.1
ICD-10 code description
Four or more of the above symptoms are usually present and the patient is likely to have great difficulty in continuing with ordinary activities. In typical mild, moderate, or severe depressive episodes, the patient suffers from lowering of mood, reducti

Primary outcomes

1

Description
depression
Timepoint
pre-test, post test, 3 month Follow-up
Method of measurement
BDI-II( beck- depression inventory- 2th edition)

2

Description
quality of life
Timepoint
pre-test, post test, 3 month Follow-up
Method of measurement
World Health Organization Quality of Life (WHOQOL-BREF)

3

Description
Metacognative Beliefs
Timepoint
pre-test، post test، 3 month Follow-up
Method of measurement
Metacognitions Questionnaire-30( MCQ-30)

4

Description
Rumination Response Style
Timepoint
pre-test, post test, 3 month Follow-up
Method of measurement
Rumination Response Scale( RRS)

Secondary outcomes

1

Description
clinical impressions
Timepoint
post test
Method of measurement
Clinical Global Impressions( CGI)

2

Description
clinical satisfaction
Timepoint
post test
Method of measurement
Clinical Satisfaction Questionnire( CSQ)

Intervention groups

1

Description
Group Metacognitive Therapy - 8 weeks session one session in each week( 8 sessions). Each session 90-120 minutes.
Category
Other

2

Description
life skills training -8 weeks session one session in each week. Each session 90-120 minutes.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Taranome Zendegi Cilinic
Full name of responsible person
Zahra Headari
Street address
Ranjbar street, between Mokhberat and Amiriyeh intersection, Bojnord
City
Bojnord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University of Torbat jam
Full name of responsible person
Vice chancellor for research Dr. Mohamad Reza Khaleghi. University of Islamic Azad of Torbat jam
Street address
7 km to Torbat jam, Mashhad road.
City
Torbat jam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Torbat jam
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
Islamic Azad University of Torbat jam.
Full name of responsible person
Zohreh Razavizadeh
Position
Master of art cadidate.
Other areas of specialty/work
Street address
7 km to Torbat jam, Mashhad road.
City
Torbat jam
Postal code
95719-9
Phone
+98 52 8224 8041
Fax
Email
razavi7585@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad Universityof Torbat jam.
Full name of responsible person
Zohreh Razavizadeh
Position
Master of art candidate.
Other areas of specialty/work
Street address
7 km to Torbat jam , Mashhad road.
City
Torbat jam
Postal code
Phone
+98 52 8221 0222
Fax
+98 52 8221 0222
Email
razavi7585@gmail.com
Web page address
http://www.iautj.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
Prof. of Clinical Psychology
Other areas of specialty/work
Street address
Tohid Shahri Street, Sabzevar
City
Sabzevar
Postal code
9617976487
Phone
+98 57 1441 0104
Fax
Email
h.shareh@yahoo.com
Web page address
http://www.hsu.ac.ir/

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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