The efficacy of group metacognitive therapy on Patients with post-traumatic stress disorder due to earthquake in Kermanshah
Design
Clinical trial with control group, Not blinded, Randomized
Settings and conduct
This study is conducted at the counseling Center of Kermanshah University of Medical Sciences. Patients receive 10 sessions of Group Metacognitive Therapy weekly. The duration of each session is 90 minutes. To evaluate the follow up period again three months after the end of the intervention the subjects are evaluated. In order to evaluate the effects of treatment subjects will be evaluated one week before, Mid-intervention, one week after and three months after the end of the intervention respectively. The intervention is done by an experienced psychologist and based on Wells Metacognitive Therapy treatmenl.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering PTSD disorder with diagnosis of psychiatrist and clinical psychologist Exit criteria: current diagnosis of any mental disorder is consistent in Diagram 1 and 2 based on a psychologist's diagnostic interview, with the exception of PTSD disorder and emotional disorders including depression, anxiety
Intervention groups
Intervention group: 15 patients with ptsd disorder receive 10 sessions of Group Metacognitive Therapy Control group: 30 people and do not receive any special treatment.
Main outcome variables
Depression; anxiety; ptsd
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190724044326N1
Registration date:2019-09-05, 1398/06/14
Registration timing:prospective
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
Registrant information
Name
sasan amiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 7884
Email address
sasanamiri2910@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-06, 1398/06/15
Expected recruitment end date
2019-10-07, 1398/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of group metacognitive therapy on Patients with post-traumatic stress disorder due to earthquake in Kermanshah
Public title
The assessment of group metacognitive therapy on Patients with post-traumatic stress disorde
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering PTSD disorder with diagnosis of psychiatrist and clinical psychologist
the individual's ability to attend a therapeutic session
The age range is between 50 to 18 years old
Affliction of PTSD disorder and having emotional symptoms including depression, anxiety based on diagnostic interview by psychologist
Motivation and satisfaction for participation during treatment
Failure to receive psychological treatment in the past year
Have at least a cycle of education
Not having a history of sexual abuse
Not having other chronic diseases such as severe liver disorder
The lack of current diagnosis of any mental disorder is consistent in Diagram 1 and 2 based on a psychologist's diagnostic interview, with the exception of PTSD disorder and emotional disorders including depression, anxiety
No obvious risk of suicide now
There is no history of drug abuse or dependence at the current time and within one year before the start of treatment
Exclusion criteria:
Unwillingness to attend research meetings
ot attending at least 50% of the sessions
Creating severe physical problems so that it can not be present at meetings
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
More than 1 sample in each individual
Number of samples in each individual:
3
Using Beck Depression Inventory (BDI-II), Beck Anxiety Inventory and Post-traumatic Stress PTSD Checklist for assessing the level of participants' problems.
Randomization (investigator's opinion)
Randomized
Randomization description
For randomizing assignment, the Simple Random method is used. 45 cards with the same appearance are provided. On 15 of cards the number 1 and on 30 of them the number 2 is written which represent the intervention group and the control group respectively. Then, one card is given to each qualified individual randomly and his assignment to the group is recorded. This process is continues until all individuals are assigned. It should be noted that participants are unaware of the nature of the numbers and type of intervention.
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 Kermanshah University of Medical Sciences
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-08-17, 1398/05/26
Ethics committee reference number
IR.KUMS.REC.1398.547
Health conditions studied
1
Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Post Traumatic Stress Disorder
Timepoint
A week before the intervention, Mid-intervention, one week after the intervention, Three months after the intervention
A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention
Method of measurement
Beck Depression Inventory (BDI-II)
2
Description
Anxiety
Timepoint
A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention
Method of measurement
Beck Anxiety Inventory
3
Description
Post-traumatic stress
Timepoint
A week before the intervention, Mid-intervention, one week after the intervention, three months after the intervention
Method of measurement
Post-traumatic Stress PTSD Checklist
Intervention groups
1
Description
Intervention group: In this study, Wells' metacognitive therapy for anxiety disorders will be used. .The sample size in this study is 45. They are randomly divided into two experimental and control groups, in which 15 subjects in the experimental group and 30 in the control group are placed and the treatment plan will be available in a group for 10 sessions.The contents of the group meta_cognitive therapy sessions are: The first session)Including referrals, Introducing ptsd disorder, Check ptsd symptoms second session) Introducing Metacognitive Therapy, Model introduction and preparation third session) Analysis of Metacognitive Positive and Negative Beliefs and Meta_cognitive Control Strategies fourth Session) Introduce Cognitive Attentional Syndrome to patients, a type of repetitive thinking that is a concern or rumination focused on threat and maladaptive behaviors (such as thought suppression, avoidance, substance use). Fifth Session) Technique of attention training, technique logic, technique validation Sixth Session) Applying Mindfulness Techniques to Breakthrough Seventh Session) Four of the ten mindfulness techniques were taught to the participants Eighth Session) Teaching the other three techniques of the ten mindfulness techniques Ninth Session) The remaining three techniques are taught to the participants Tenth Session) Prepare members for closure
Category
Behavior
2
Description
Control group: Control group: Control group: consists of 30 people who are waiting in the waiting list and do not receive treatment during the time of intervention. but after treatment, they will receive several sessions of meta_cognitive group therapy maintaining the ethics of the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences
Full name of responsible person
sasan amiri
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sasanamiri2910@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Central Building of Kermanshah University of Medical Sciences, Shahid Beheshti Blvd, Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
farid_n32@yahoo.com
Grant name
Kermanshah University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
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
Kermanshah University of Medical Sciences
Full name of responsible person
sasan amiri
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sasanamiri2910@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
sasan amiri
Position
MSc
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
sasanamiri2910@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Aliakbar Parvizifard
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah Faculty of Medicine, Imam Reza Hospital, Shahid Shiroudi Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 84 3442 3968
Email
Parvisia@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD