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Determining the effectiveness of, mindfulness-based cognitive therapy and expressive writing on the reduction of trauma-induced experiences

Protocol summary

Study aim
Determining the effectiveness of mindfulness-based cognitive therapy and expressive writing on the reduction of post traumatic stress symptoms and experiential avoidance.
Design
Clinical trials with control group, Parallel Group, non random groups
Settings and conduct
Participants will first complete the informed consent forms for participation. Then, they will be examined based on the inclusion criteria.Then, participants will be assigned into 3 groups(7 in each group).Before and after the interventions the study variables will be assessed using the questionnaires. The follow-up will be one months after the end of the interventions. The interventions will be provided in neighborhood houses and health centers. The control participants will also receive the interventions after the follow-up.
Participants/Inclusion and exclusion criteria
The study sample will be people who show mild to moderate symptoms of post traumatic stress disorder. Inclusion Criteria: 1- 18 years of age and above, 2- having experienced at least one traumatic event, 3- experiencing mild to severe signs and symptoms (indicated by clinical interview and the PTSD Checklist for DSM-5 (PCL-5)), 3- not diagnosed with post-traumatic stress disorder (PTSD), major depressive disorder (MDD), or psychotic symptoms, 4- not receiving pharmacological treatment for psychological disorders. Exclusion Criteria: 1- Suffering from conditions preventing them from participation, 2- receiving pharmacological treatment at the time of the study, 3- diagnosed with major depressive disorder (MDD) (with a score above 28 on the Beck Depression Inventory (BDI)), 4- not interested in continuing participation in the study.
Intervention groups
1- Mindfulness-Based Cognitive Therapy group 2- expressive writing group 3- Control group
Main outcome variables
Post Traumatic Stress Symptoms, Mindfulness, Experiential Avoidance, Depression, General health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181004041228N1
Registration date: 2018-10-19, 1397/07/27
Registration timing: prospective

Last update: 2018-10-19, 1397/07/27
Update count: 0
Registration date
2018-10-19, 1397/07/27
Registrant information
Name
Soofi Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 6629
Email address
s.moradi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-28, 1397/08/06
Expected recruitment end date
2018-11-23, 1397/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determining the effectiveness of, mindfulness-based cognitive therapy and expressive writing on the reduction of trauma-induced experiences
Public title
Mindfulness-based cognitive therapy and expressive writing on the reduction of trauma-induced experiences
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
18 years of age and above. Having experienced at least one traumatic event. Experiencing mild to moderate signs and symptoms (indicated by clinical interview and the PTSD Checklist for DSM-5 (PCL-5)). Not diagnosed with post-traumatic stress disorder (PTSD), major depressive disorder (MDD), or psychotic symptoms. Not receiving pharmacological treatment for psychological disorders.
Exclusion criteria:
Suffering from conditions preventing them from participation. Receiving pharmacological treatment at the time of the study. Diagnosed with major depressive disorder (MDD) (with a score above 28 on the Beck Depression Inventory (BDI-II)). Not interested in continuing participation in the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
Ethics committee of Beheshti University of Medical Sciences
Street address
No.17, Sadat Alley, South Khosh Ave, Hashemi Ave, Tehran Town.
City
Tehran
Province
Tehran
Postal code
1346635159
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.SBMU.MSP.REC.1395.604

Health conditions studied

1

Description of health condition studied
Post Traumatic Stress Symptoms
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified

Primary outcomes

1

Description
Score in the post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition
Timepoint
Before the intervention, after the intervention, one month after the end of the intervention
Method of measurement
Post-traumatic stress disorder checklist for Diagnostic and Statistical Manual of Mental Disorders, 5th Edition

2

Description
Score in the Multidimensional Experiential Avoidance Questionnaire
Timepoint
Before the intervention, after the intervention, one month after the end of the intervention
Method of measurement
Multidimensional Experiential Avoidance Questionnaire

3

Description
Score in the Five Facet Mindfulness Questionnaire
Timepoint
Before the intervention, after the intervention, one month after the end of the intervention
Method of measurement
Five Facet Mindfulness Questionnaire

Secondary outcomes

1

Description
Score in the Beck Depression Inventory-II
Timepoint
Before the intervention, after the intervention, one month after the end of the intervention
Method of measurement
Beck Depression Inventory-II

2

Description
Score in the General Health Questionnaire-28
Timepoint
Before the intervention, after the intervention, one month after the end of the intervention
Method of measurement
General Health Questionnaire-28

Intervention groups

1

Description
Intervention group 1: Mindfulness-Based Cognitive Therapy (MBCT) group (8 sessions of group MBCT; groups with 7 members)
Category
Treatment - Other

2

Description
Intervention group 2: expressive writing (EW) group (4 sessions of group therapy; groups with 7 members)
Category
Treatment - Other

3

Description
Control group: Control group
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Department of Tehran
Full name of responsible person
Zeinab Nasiri
Street address
Kurdistan Highway, Shahid Gomnam Highway, North Arshad Ave., Building of social and cultural deputy.
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 8210 6000
Email
info@farhangi.tehran.ir

2

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziai
Street address
No.2, Arabi Ave, Velenjak، , Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
msp@sbmu.ac.ir

3

Recruitment center
Name of recruitment center
Deputy of Health System Research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahnam Arshi
Street address
5th floor, The former building of the Ministry of Health, Hafez str., Jomhori Ave., Tehran.
City
Tehran
Province
Tehran
Postal code
1134845764
Phone
+98 21 6673 6810
Email
HSR.health@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor in Research Affairs
Full name of responsible person
Afshin Zarghi
Street address
No.2, Arabi Ave, Velenjak، , Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor in Research Affairs
Proportion provided by this source
70
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soofi Moradi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, Arabi Ave, Velenjak، , Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
s.moradi@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soofi Moradi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, Arabi Ave, Velenjak، , Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 6636 6629
Email
s.moradi@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soofi Moradi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.2, Arabi Ave, Velenjak، , Tehran,Tehran Province
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 6636 6629
Email
s.moradi@sbmu.ac.ir

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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