Protocol summary

Study aim
The present study was designed to investigation the changes in well-being during mindfulness based of cognitive therapy(MBCT) in students as well as the process of changing variables in this type of intervention.
Design
in this study forty dormitory students of Shahed University were selected by available sampling method and randomly assigned to four groups of mindfulness based of cognitive therapy
Settings and conduct
The protocol was eight ninety minute sessions. Four groups completed Ryffs Scales of Psychological Well-being , experiences questionnaire(EQ) , cognitive emotional regulation, Savoring Beliefs Inventory, and Alternate uses task(AUT) before intervention and then simultaneously started their sessions. The first group after two weeks of intervention, the second group after four weeks, the third group after six weeks, and the fourth group after eight weeks recompleted the scales.
Participants/Inclusion and exclusion criteria
Undergraduate students, aged between 18 and 23 who have not received psychological therapy and psychiatric medicine for the last 6 months.
Intervention groups
The first group,Performing two weeks of Mindfulness based of cognitive therapy. The second group,Performing four weeks of Mindfulness based of cognitive therapy. The third group,Performing six weeks of Mindfulness based of cognitive therapy. The fourth group,Performing eight weeks of Mindfulness based of cognitive therapy.
Main outcome variables
Well-being

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120612010008N3
Registration date: 2018-03-29, 1397/01/09
Registration timing: retrospective

Last update: 2018-03-29, 1397/01/09
Update count: 0
Registration date
2018-03-29, 1397/01/09
Registrant information
Name
Elham Aghaei
Name of organization / entity
Isfahan University
Country
Iran (Islamic Republic of)
Phone
+98 21 2632 2449
Email address
elhamaghaei87@yahoo.com
Recruitment status
Recruitment complete
Funding source
Without financial support done.
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
2017-05-22, 1396/03/01
Actual recruitment end date
2017-07-23, 1396/05/01
Trial completion date
empty
Scientific title
Study of Well-being Changes During Mindfulness Based of Cognitive Therapy in Students : a Process of Change Study
Public title
Effect of Mindfulness Based of Cognitive Therapy on Well-being
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All students aged 18 to 23 years Undergraduate students Living at the Girl's dormitory at Shahed University Get at least 12 points in the Psychological distress questionnaire ( K10). Agreement to participate in studying and signing written consent
Exclusion criteria:
Get any psychological and Psychiatry treatment in the last 6 months Earning score more than 27 points in the Psychological distress questionnaire ( K10).
Age
From 18 years old to 23 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The present study examines the process of change Through the multilevel analysis method

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.Shahed.REC.1396.3

Health conditions studied

1

Description of health condition studied
Students with emotional symptoms who do not have the severity to diagnose a clinical disorder based on a psychological distress scale(K10)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
well-being
Timepoint
before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks.
Method of measurement
Ryffs Scales of Psychological Well-being

Secondary outcomes

1

Description
decentralization
Timepoint
before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks.
Method of measurement
experiences questionnaire

2

Description
Broad attention
Timepoint
before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks.
Method of measurement
Alternate uses task

3

Description
positive reappraisal
Timepoint
before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks.
Method of measurement
cognitive emotional regulation questionnaire

4

Description
savoring
Timepoint
before intervention,In the first group after two weeks,In the second group after four weeks,In the third group after six weeks,In the fourth group after eight weeks.
Method of measurement
Savoring Beliefs Inventory

Intervention groups

1

Description
Intervention group1, Performing 2 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing)
Category
Prevention

2

Description
Intervention group 2, Performing 4 Weeks of Mindfulness based cognitive therapy( Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest•)
Category
Prevention

3

Description
Intervention group3, Performing 6 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• )
Category
Prevention

4

Description
Intervention group 4, Performing 8 Weeks of Mindfulness based cognitive therapy(• Week 1—Moving from living on “automatic pilot” to living with awareness andconscious choice• Week 2—Moving from relating to experience through thinking to directly sensing• Week 3—Moving from dwelling in the past and future to being fully in the presentmoment• Week 4—Moving from trying to avoid, escape, or get rid of unpleasant experienceto approaching it with interest• Week 5—Moving from needing things to be different to allowing them to be justas they already are• Week 6—Moving from seeing thoughts as facts and real to seeing them as mentalevents that may not correspond to reality• Week 7—Moving from treating yourself harshly to taking care of yourself withkindness and compassion• Week 8—Planning a mindful future)
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Avini Dormitory Counseling Center, Shahed University, Tehran
Full name of responsible person
Elham Aghaie
Street address
Shahed University, Tehran- Gom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
elhamaghaei87@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Vice chancellor for research, Shahed University
Street address
Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
elhamaghaei87@yahoo.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Elham Aghaie
Position
Phd candidate of clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Fax
Email
elhamaghaei87@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Elham Aghaie
Position
دانشجوی دکتری رواشناسی بالینی
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahed University, Tehran- Ghom freeway, Opposite Holy Shrine of Imam Komeini, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 21 51210
Fax
Email
elhamaghaei87@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Elham Aghaie
Position
psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
In front of the Holy Shrine of Imam Khomeini, tehran-Ghom Persian Gulf Highway,Tehran.
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Fax
Email
elhamaghaei87@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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