The effectiveness of personalized computerized inhibitory training program (P-CIT) with Exposure and Response Prevention on the outcome of therapy in Patients with Contamination Obsessive-Compulsive Disorder
evaluate the effect of a computer training program with exposure and response prevention(ERP) in reducing the symptoms of obsessive-compulsive disorder, depression, anxiety and increasing the quality of life and task control of people with OCD of the type of contamination / washing.
Design
Clinical trial, with control and experimental groups, parallel, single blind, randomized, on 30 patients. A randomization table is used for randomization
Settings and conduct
From patients with OCD subtype contamination/washing who referred to the clinic of the Faculty of Behavioral Sciences and Mental Health,Hazrat Rasoul Akram Hospital and Iran Psychiatric Hospital in 2021 ,30 people will be selected and will assign randomly to groups.The pre-tests are performed by an evaluation that is blinded by assigning the code to the groups. Then, before starting the ERP treatment, the experimental group receives P-CIT and and starts its daily implementation at home, and 1 week later they enter ERP treatment while continuing to run it. The control group enters ERP treatment without receiving a program. ERP treatment for both groups are performed in the clinic of the Faculty of Behavioral Sciences and Mental Health. At the end the post-test is taken and the data are analyzed by a blinded statistical analyst.
Participants/Inclusion and exclusion criteria
inclusion criterion:Initial diagnosis of obsessive-compulsive disorder
exclusion criterion:Concurrent psychiatric disorders
Intervention groups
The intervention group includes patients with obsessive-compulsive disorder (OCD) of the type of contamination / washing who receive a combined intervention of a personalized computerized inhibitory training(PCIT) program with exposure and response prevention (ERP).
The control group includes patients with OCD of the type of contamination / washing who receive a ERP.
Main outcome variables
Obsessions and compulsions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211027052887N1
Registration date:2021-10-31, 1400/08/09
Registration timing:prospective
Last update:2021-10-31, 1400/08/09
Update count:0
Registration date
2021-10-31, 1400/08/09
Registrant information
Name
fatemeh jafarian dhkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 6091
Email address
fatemehjafarian1112@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-06, 1400/08/15
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of personalized computerized inhibitory training program (P-CIT) with Exposure and Response Prevention on the outcome of therapy in Patients with Contamination Obsessive-Compulsive Disorder
Public title
The effectiveness of personalized computerized inhibitory training program (P-CIT) with Exposure and Response Prevention on obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Initial diagnosis of obsessive-compulsive disorder (OCD) by a psychiatrist and then obtaining a score of 16 or higher on the Yale-Brown Obsessive-Compulsive Disorder Scale (YBOCS)
Having insight so that the patient is aware of the problems and illness and also has a non-insane understanding of the cause and meaning of her illness.
Familiarity with computers and email and how to work with them
Age between 18 to 55 years’ old and At least Diploma education
Exclusion criteria:
Receiving psychological and pharmacological treatments for 3 months before entering the study (in the case of patients treated with psychiatric drugs if the dose of the drug in them is stable 6 weeks before the study and remains at the same dose during the study from Study will not be deleted).
Concurrent psychiatric disorders such as bipolar disorder and related disorders, schizophrenia spectrum disorders and other psychotic disorders, addictive disorders and substance-related disorders (In the case of other mental disorders, patients will not be excluded from the study if the symptoms of OCD are more severe and harmful than the symptoms of the accompanying mental disorder).
Having vision problems that can not be treated with medical treatment or prescription glasses.
Having hearing problems that can not be treated with medical treatment or hearing aids.
Having serious thoughts of active suicide
Organic brain disorder based on family and patient reports
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the Restricted Randomization method of Balance Block Randomization will be used.The size of all the blocks was equal and in this study, we will have 4 blocks. Excel will be used for generation of random sequence .Allocation concealment is also used. Using Sequentially numbered, sealed, opaque envelopes, each random sequence created is recorded on a card. And the cards are placed in the envelopes of the letter, respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluator and statistical analysts are blind to the research process. Statistical analyst is blind to research so that data analysis can be done without bias
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor
City
tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-12-07, 1399/09/17
Ethics committee reference number
IR.IUMS.REC.1399.972
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
Severity of signs and symptoms in patients with obsessive-compulsive disorder
Timepoint
before the intervention, last session, 2 months after the intervention
Method of measurement
Yale-brown obsessive compulsive scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
World Health Organization's Quality of Life Questionnaire (WHOQOL-BREF)
2
Description
task control
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
Stroop
3
Description
Anxiety, depression, stress
Timepoint
before the intervention, last session, 2months after intervention
Method of measurement
Depression Anxiety and Stress Scales
Intervention groups
1
Description
Intervention group: personalized computerized inhibitory training program (P-CIT) with exposure and response prevention (ERP): First, participants complete the research questionnaires as a pre-test, then 1 week before the start of ERP sessions, in order to personalize the training program. In individual sessions, the computer inhibitor will first view and confirm the obsessive-compulsive images used in the program, which have been approved by experts and individuals with obsessive-compulsive disorder and localized, and after the necessary explanations and practical training, The P-CIT program, along with OpenSesame 3.0 software (using Pytho 2.7.6), will be available for installation and running at home and will run for seven days, three times a day (each time). 15 minutes) will do. After seven days at the clinic, they will begin a course of 17 sessions of ERP treatment while continuing to perform P-CIT. In this way, 2 treatment sessions are held for each person every week.. They run the program 3 times a day at home during the research and intervention, and will deliver the result of each run in the form of an Excel file to the therapist in the next session. It should be noted that the images will be updated at each stage of treatment based on the patient's current most annoying symptoms and will be approved by each person in the experimental group before implementation.At the end of the ERP sessions and again in the follow-up phase, after 2 months, participants will complete the research questionnaires again.
Category
Treatment - Other
2
Description
Control group:exposure and response prevention(ERP): Participants first complete the research questionnaires as a pre-test. The control group also entered the treatment of 17 sessions of exposure and prevention of response according to the guideline of exposure therapy and prevention of response (ritual) for obsessive-compulsive disorder without any computer program. They will be held in such a way that 2 treatment sessions are held for each person every week. ERP Sessions: Session 1: The therapist begins to gather information about the patient's obsession and his or her medical history. The rationale and description of the treatment will also be stated for the patient and the issue of self-review will be raised. Confrontation topics will be prepared. Sessions 3 to 7: Confrontation and prevention of rituals will be practiced in each session, which will gradually increase their difficulty until the eighth session. Depending on the patient's symptoms, prescriptions for visual encounters will be provided. Session 8: The patient will face the highest item in his or her hierarchy. Session 9-16: Repetition or variation of previous encounters and other introductions. Anxiety-inducing stimuli will be incorporated into the hierarchy. (If possible, one or two visits to the patient's home are recommended to observe and guide his or her encounters.) Final Session: Assessing the patient's therapeutic progress and preparing him or her to return to normal behavior will discuss strategies to prevent relapse. Finally, four to six follow-up telephone calls will be made on a weekly basis to assist the patient in the transition from the active phase of treatment. At the end of the ERP sessions and again in the follow-up phase, after 2 months, participants will complete the research questionnaires again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Psychiatric Institute, Iran Psychiatric Hospital, Hazrat Rasoul Akram Hospital