The aim of this research is to investigate the effectiveness of combination of pharmachothrapy with metacognitive therapy versus pharmachotherapy in patient with posttraumatic stress disorder.
Method: six males selected by convenient sampling and randomly assigned to two treatment groups. The methodology is a multiple-baseline experimental single case study. Subjects completeی Clincian-Adminestered PTSD Scale (CAPS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI), Subject Unit of Stress (SUDs), at pre-treatment(baseline), treatment (4 and 8 sessions), post-treatment (twelfth) and at follow-up (two months after treatment). Also subjects will complete, Metacognition questonare (MCQ-30), General assessment scale (GAFs), at pre-treatment (baseline) and post-treatment.
Key word: metacognitive therapy, posttraumatic stress disorder, pharmachotherapy pharmachotherapy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060828504N2
Registration date:2017-06-27, 1396/04/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Vida Yousefi Asl
Name of organization / entity
Zanjan University of Mrdical Science
Country
Iran (Islamic Republic of)
Phone
+98 24 3342 4766
Email address
vida.yousefi@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Iran University of medical Sciences
Expected recruitment start date
2009-04-25, 1388/02/05
Expected recruitment end date
2009-11-21, 1388/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of combination of pharmachothrapy with metacognitive therapy versus pharmachotherapy in patient with posttraumatic stress disorder
Public title
Effectiveness of combination of pharmachothrapy with metacognitive therapy versus pharmachotherapy in patient with posttraumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having a chronic PTSD based on DSM-4 criterias؛ Do not receive psychological treatment before the study؛ In the case of using medicine, the possibility of keeping the type and dose of drugs during the study؛ Minimum 18 years and maximum 50 years، with at least third level education؛ The patient agreed to participate in the study and signed a written consent.
Exclusion criteria: having a psychotic disorder and substance use disorder؛ Having full criteria for personality disorder in Axis II؛ There are risks for the patient such as having serious thoughts of suicide.
Age
From 18 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
6
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Pre test, Post test, Follow up ( 1month), Follow up ( 2 month)
Method of measurement
Subjective unit of distress scale
2
Description
Anxiety
Timepoint
Pre test, Post test, Follow up ( 1 month) , Follow up ( 2 month)
Method of measurement
Beck anxiety inventory
3
Description
PTSD Signs
Timepoint
Pre test, Post test, Follow up ( 1 month) , Follow up ( 2 month)
Method of measurement
PTSD Inventory
4
Description
Depression
Timepoint
Pre test, Post test, Follow up(1 month), Follow up( month)
Method of measurement
Beck depression inventory
5
Description
Metacognition
Timepoint
Pre test, Post test, Follow up(1 month), Follow up(2 month)
Method of measurement
Metacognition Questionnaire-30 (MCQ-30)
6
Description
General functioning
Timepoint
Pre test, Post test, Follow up ( 1 month),Follow up (2 month)
Method of measurement
General assessment of functioning
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group1: (Drug treatment) Patients receive medication in addition, questionnaires: Clincian-Adminestered PTSD Scale (CAPS), beck anxiety (BAI), beck depression(BDI-II), Metacognition questonare (MCQ-30), subjective units of discomfort(SUDs), complete and general functioning will be assesed.
Category
Treatment - Drugs
2
Description
Intervention group2: Combination of pharmachothrapy with metacognitive therapy: Subjects complete CAPS, BDI-II, BAI, SUDs, MCQ-30, GAFs at pre test, post test and follow up.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Zanjan
Full name of responsible person
Mohsen Dadashi
Street address
Shahid beheshti Hospital, Sadi street, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Seyed Kazem Malakuti
Street address
Mansouri Street, Niyayesh Street, Sattra khan Street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Iran University of Medical Sciences
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
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant professor of Zanjan University of Medical Sciences
Other areas of specialty/work
Street address
Department of clinical psychology, Saadi street, zanjan,Iran
City
Zanjan
Postal code
4513615788
Phone
+98 242433534500
Fax
Email
vida.yousefi@zums.ac.ir; mohsendadashi@zums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant professor of Zanjan University of Medical Sciences
Other areas of specialty/work
Street address
Department of clinical psychology ,Zanjan University of Medical Sciences,
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
+98 45 1361 5788
Email
vida.yousefi@zums.ac.ir; mohsendadashi@zums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Dadashi
Position
Assistant professor of Zanjan University of Medical Sciences
Other areas of specialty/work
Street address
Department of clinical psychology, Zanjan University of Medical Sciences,
City
Zanjan
Postal code
Phone
+243 35 34500
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)