Explaining the effect of psychodrama on reducing the signs and symptoms of obsessive-compulsive disorder,anger and guilt in patients suffering from obsessive-compulsive disorder
Design
A single-center, parallel-group, randomized not blinded clinical trial. Sampling was performed by the randomization method. samples were 24 patients who were randomly assigned to experimental (12 patients) and control(12 patients) groups by block randomization. Sampling was performed by the blocking randomization method. Patients who have inclusion criteria will be assessed using randomizer computer software and randomly assigned with 4 and 6 block sizes with 1: 1 allocation to the two groups of intervention and control.
Settings and conduct
Sessions were held for 4 weeks , 3 times a week in Nikavin clinic in Isfahan city. Before the intervention, an introductory session was held for the members of the experimental group, in which members received the necessary information and informed consent was obtained from all the participants ,also group psychotherapy norms were conducted and informed to the members of the group. there was no special time limitation for sessions , sessions timeout was almost 5-6 hours,so that every member had the opportunity to play in the role of the protagonist , and psychodrama techniques were used for them.
Participants/Inclusion and exclusion criteria
Age:20-35 year-old patients, graduated from high school, no addiction, no personality disorder
Intervention groups
Both groups received fluoxetine ,other than that experimental group participated in psychodrama sessions
Main outcome variables
Signs and symptoms of obsessive-compulsive disorder, anger, guilt
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200414047068N1
Registration date:2020-07-31, 1399/05/10
Registration timing:retrospective
Last update:2020-07-31, 1399/05/10
Update count:0
Registration date
2020-07-31, 1399/05/10
Registrant information
Name
Melina Shiranibidabadi
Name of organization / entity
Islamic Azad University of Shiraz
Country
Iran (Islamic Republic of)
Phone
+98 31 3220 7795
Email address
melinashirani4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-12, 1399/02/23
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
2020-05-12, 1399/02/23
Actual recruitment end date
2020-05-20, 1399/02/31
Trial completion date
2020-06-27, 1399/04/07
Scientific title
Efficacy of psychodrama on reducing the signs and symptoms of obsessive-compulsive disorder,anger and guilt in patients with OCD
Public title
Effect of Psychodrama on obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
OCD
Graduated from high school
Exclusion criteria:
addiction.
personality disorders.
being absent for more than 2 sessions
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was performed by the blocking randomization method. Patients who have inclusion criteria will be assessed using randomizer computer software and randomly assigned with 4 and 6 block sizes with 1: 1 allocation to the two groups of intervention and control.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A single- center, parallel-group, randomized clinical trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University-Shiraz Branch
Street address
Islamic Azad University,Shiraz branch, 5th km of Sadra highway, Shiraz
City
Shiraz
Province
Fars
Postal code
71987-74731
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1399.001
Health conditions studied
1
Description of health condition studied
Obsessive-Compulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Signs and symptoms of obsessive-compulsive disorder
Timepoint
before intervention and 30 days after starting intervention
Method of measurement
Madsley Obsessive-Compulsive Inventory
Secondary outcomes
1
Description
Anger in people with Obsessive-Compulsive Disorder
Timepoint
Before intervention and 30 days after starting intervention
Method of measurement
Novaco anger inventory short-form
2
Description
Guilt in people with obsessive-compulsive disorder
Timepoint
Before intervention and 30 days after starting intervention
Method of measurement
Izenc guilt inventory
Intervention groups
1
Description
Intervention group: 12 patients suffering from obsessive-compulsive disorder who receive fluoxetine and participate in group psychodrama sessions for one-month(12 sessions). before and after the intervention , participants answer Maudsley obsessive-compulsive questionnaire, Novaco anger scale(short-form), and Eysenck guilt questionnaire.
Category
Treatment - Other
2
Description
Control group: 12 patients suffering from obsessive-compulsive disorder who receive fluoxetine and do not participate in psychodrama sessions.