Protocol summary

Summary
This study is a comparison between the effectiveness of the cognitive behviour therapy and the mindfulness-based cognitive therapy (MBCT) on the decrease of the ruminative response on women suffering from depression. For this means 30 women who have been diagnosed with infertility by gynecologists and depression according to the Beck 2 Depression inventory have been chosen and have been assigned randomly into two groups, one experimental and one control group each contains 10 members. For one of the groups during twelve sessions (two hours a week) cognitive behaviour therapy and for the other group eight sessions (two hours a week) mindfulness-based cognitive therapy (MBCT) will be applied. At the start of the process, the end and one month later they will be tested on the ruminative response scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111027981N1
Registration date: 2011-12-26, 1390/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-26, 1390/10/05
Registrant information
Name
Ali Reza Feili
Name of organization / entity
Payamnoor university
Country
Iran (Islamic Republic of)
Phone
+98 71 1654 1570
Email address
ar_feili@pnu.ac.ir
Recruitment status
Recruitment complete
Funding source
Allameh university
Expected recruitment start date
2011-10-22, 1390/07/30
Expected recruitment end date
2011-12-06, 1390/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison Study of Effectiveness of Cognitive–Behavior Therapy and Teasdale Mindfulness-Based Cognitive Therapy of Infertile Depressed Women’s Rumination
Public title
Comparing the techniques of cognitive behavior therapy in reducing the minds of rumination
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diagnosis of infertility according to gynecologists; infertility for at least one year; age range of 20 to 45; diagnosed as depression according to the results of beck 2 depression inventory; high school educated. Exclusion criteria: having a history of pregnancy prior to the infertility diagnosis; going under psychological treatment or taking medication for psychological problems.
Age
From 20 years old to 45 years old
Gender
Female
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
Allameh university
Street address
Faculty of Psychology and Educational Sciences, Allameh Tabatabaei University, Olympic Village, west Hemmat Highway
City
Tehran
Postal code
Approval date
2011-04-26, 1390/02/06
Ethics committee reference number
1397-83

Health conditions studied

1

Description of health condition studied
Rumination
ICD-10 code
F00-F99
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Rrduce Rumination
Timepoint
The end of period
Method of measurement
Rumination scale response

Secondary outcomes

1

Description
Recurrent rumination
Timepoint
One month after treatment
Method of measurement
Rumination scale response

Intervention groups

1

Description
First group: Twelve 2-hours weekly sessions will be held and the mitigation and prevention of rumination will be taught according to Beck cognitive-behavioral treatment subjects. At the end of each session, homework is given to individuals and the beginning of the next session the performance and results will be discussed.
Category
Other

2

Description
Second group: Eight 2-hours weekly sessions for prevention and control methods based on cognitive-based rumination mind awareness (Tyzdl). At the end of each session, homework is given to individuals and the beginning of the next session the performance and results will be discussed. In this study, the control group received no drug or psychological treatment.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr.Tavazo, Ladies Clinic
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Allameh University
Full name of responsible person
Dr.Ahmad Borjali
Street address
Faculty of Psychology and Educational Sciences, Allameh Tabatabaei University, Olympic Village, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Allameh University
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
Payamnoor Uniwersity
Full name of responsible person
Ali Reza Feili
Position
Phd Student
Other areas of specialty/work
Street address
Payam Noor University, southern Hemmat St.
City
Shiraz
Postal code
Phone
+98 71 1630 3230
Fax
Email
ar_feili@pnu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Payamnoor university
Full name of responsible person
Ali Reza Feili
Position
Phd Student
Other areas of specialty/work
Street address
Payam Noor University, southern Hemmat St.
City
Shiraz
Postal code
Phone
+98 71 1630 3230
Fax
Email
ar_feili@pnu.ac.ir
Web page address

Person responsible for updating data

Contact

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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