Protocol summary

Study aim
Because the role of depression in suicide attempt is significant, the present study aims to examine how and to what extent mindfulness based cognitive therapy and rumination cognitive behavioral therapy affect cognitive, behavioral, and emotional components of depression.
Design
This study will design a pre-post design using a control group and two intervention arms. Assessments will be made at the beginning, after the fifth week at the end of treatment and at 2 months follow-up.Two arm parallel group randomized trial with control group.
Settings and conduct
In this study adolescent girls who attempted suicide and referred to the Samen-al-aemeh Imam Hassan Bojnourd City Hospital were studied. After a diagnostic interview and a Beck Depression Inventory 2, they enter the study if the BDI_II score is above 14 and do not require medication according to the psychiatrist's instructions. They are then randomly assigned to three groups. Examples of each group are 10 individuals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: adolescent girls who come to the hospital with suicide attempt and have definite depression disorder definite depression disorder after reviewing through structured clinical interview and Beck-II Depression Inventory Exclusion criteria: having a personality disorder and receiving any current biological or psychological treatment
Intervention groups
There are three groups in this study. Participants in the first group receive mindfulness-based cognitive therapy individually, and the second group receive rumination-focused cognitive behavioral therapy individually. The third group is control subjects who do not receive any treatment intervention.
Main outcome variables
Find out which components of the study respond best to treatment;depressive adolescent with high rumination responds to which treatment; How is the RFCBT compared to the MBCT?

General information

Reason for update
Acronym
MBCT and RFCBT
IRCT registration information
IRCT registration number: IRCT20191012045068N1
Registration date: 2019-12-22, 1398/10/01
Registration timing: registered_while_recruiting

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
hadi Izanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3223 0371
Email address
izanloo.hadi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Mindfulness Based Cognitive Therapy and Rumination Focused Cognitive Behavioral Therapy on cognitive, behavioral, and emotional components of depression in depressed teenage girls following a suicide attempt
Public title
Effect of Mindfulness Based Cognitive Therapy and Rumination Focused Cognitive Behavioral Therapy in Depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Teenage girls who went to the hospital with suicide attempts. After the interview and questionnaire depression disorder is definite
Exclusion criteria:
Drug use for the past six months Personality Disorders and Comorbidity Other Disorders Based on Diagnostic Interview Use of any psychological intervention in the past year
Age
From 14 years old to 19 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
This study uses simple and individualized randomization. And also the random number table is used as a tool. In this study, subjects are not related to each other.
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
Ethics committee of North Khorasan University of Medical Sciences
Street address
No. 8, Shahid Reza Emami 30 Alley., North Shahid Reza Emami Ave
City
Bojnourd
Province
North Khorasan
Postal code
9415938943
Approval date
2019-11-16, 1398/08/25
Ethics committee reference number
IR.NKUMS.REC.1398.099

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode

Primary outcomes

1

Description
Depression score on Beck questionnaire
Timepoint
Measure depression score at baseline, fifth week, end and two months later
Method of measurement
Beck-II Depression Inventory

Secondary outcomes

1

Description
Anxiety score on Beck Anxiety Inventory
Timepoint
Anxiety score at baseline, end and two months later
Method of measurement
Beck Anxiety Inventory

2

Description
Rumination score on Rumination Response Scale
Timepoint
Rumination score at baseline, fifth week, end and two months later
Method of measurement
Rumination Response Scale

3

Description
The score of cognitive coping strategies in Cognitive Emotion Regulation Questionnaire
Timepoint
Measure of cognitive emotion regulation score at baseline, end and two months later
Method of measurement
Cognitive Emotion Regulation Questionnaire

4

Description
suicidal ideation score on Suicide Probability Scale
Timepoint
Measure of suicidal ideation score at baseline, end and two months later
Method of measurement
Cull & Gill Suicide Probability Scale

5

Description
Impulsiveness score on Barratt Impulsiveness Scale
Timepoint
Measure of impulsiveness score at baseline, end and two months later
Method of measurement
Barratt Impulsiveness Scale

6

Description
Depression-related beliefs score on Motabi Scale
Timepoint
Measure of depression-related beliefs score at baseline, end and two months later
Method of measurement
Motabi Depression-Related Beliefs Scale

7

Description
Anxious arousal score on Mood and Anxiety Symptoms Questionnaire
Timepoint
Measure of anxious arousal score at baseline, fifth week, end and two months later
Method of measurement
Mood and Anxiety Symptoms Questionnaire

8

Description
Hopelessness score on Suicide Probability Scale
Timepoint
Measure of hopelessness score at baseline, end and two months later
Method of measurement
Cull & Gill Suicide Probability Scale

9

Description
Negative self-evaluation score on Suicide Probability Scale
Timepoint
Measure of negative self-evaluation score at baseline, end and two months later
Method of measurement
Cull & Gill Suicide Probability Scale

10

Description
Anhedonia score on Mood and Anxiety Symptoms Questionnaire
Timepoint
Measure of anhedonia score at baseline, fifth week, end and two months later
Method of measurement
Mood and Anxiety Symptoms Questionnaire

Intervention groups

1

Description
Intervention group 1: The group that will receive mindfulness based cognitive therapy weekly for ten sessions.
Category
Treatment - Other

2

Description
Intervention group 2: The group that will receive rumination focused cognitive behavioral therapy weekly for ten sessions.
Category
Treatment - Other

3

Description
Control group: A group that does not receive intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hassan Hospital
Full name of responsible person
Ramin Haghighi
Street address
Imam Hassan Hospital, Pardis Town, Arkan Road
City
بجنورد
Province
North Khorasan
Postal code
9415938943
Phone
+98 58 3151 4100
Fax
+98 58 3151 4002
Email
izanloo.hadi@yahoo.com
Web page address

2

Recruitment center
Name of recruitment center
Samen-Al-aemeh Hospital
Full name of responsible person
Behzad Ramezani Farkhani
Street address
Samen-Al-aemeh Hospital, Chamran Street, Bojnourd
City
Bojnourd
Province
North Khorasan
Postal code
9418634758
Phone
+98 58 3223 1851
Fax
+98 58 3222 1384
Email
samen.hos@tamin.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Hassan Hashemi
Street address
Islamic Azad University , Birjand Branch, end of Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717813118
Phone
+98 56 3131 0000
Fax
+98 56 3234 5511
Email
r.khosravi@iaubir.ac.ir
Web page address
http://www.iaubir.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hadi Izanloo
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, 30 Shahid Emami Alley, Shahid Reza Nurth St, Bojnourd City
City
Bojnourd
Province
North Khorasan
Postal code
9415938943
Phone
+98 58 3223 0371
Fax
Email
izanloo.hadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Shahabizadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University , Birjand Branch, end of Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717813118
Phone
+98 56 3131 0000
Email
f_shahabizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hadi Izanloo
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8, 30 Shahid Emami Alley, Shahid Reza Nurth St, Bojnourd City
City
Bojnourd
Province
North Khorasan
Postal code
9415938943
Phone
+98 58 3223 0371
Fax
Email
izanloo.hadi@yahoo.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
After identifying individuals, demographic data and data from the intervention's effect on the dependent variables will be shared
When the data will become available and for how long
One year after the results were published
To whom data/document is available
Researchers, scientific and academic institutions
Under which criteria data/document could be used
If the analysis is done on the data according to the two indicators including depression and suicide attempt. also, all statistical information if quantitative (not qualitative) is cited
From where data/document is obtainable
hadi izanloo izanloo.hadi@yahoo.com 09361952262
What processes are involved for a request to access data/document
Individuals can request by email after submitting their identities and by referring them to the relevant organization.
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