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IRCT20211027052887N1 IRCT 2021-10-31 Iran University of Medical Sciences The effectiveness of personalized computerized inhibitory training program (P-CIT) with Exposure and Response Prevention on obsessive-compulsive disorder 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 2021-11-06 anticipated 30 Complete https://irct.ir/trial/59658 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Obsessive-compulsive disorder. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public fatemeh jafarian dehkordi
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 fatemehjafarian1112@gmail.com Iran University of Medical Sciences scientific fatemeh jafarian dehkordi
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 fatemehjafarian1112@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 55 years Both 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 F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other 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. 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. 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. 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). Task control. Timepoint: before the intervention, last session, 2months after intervention. Method of measurement: Stroop. Anxiety, depression, stress. Timepoint: before the intervention, last session, 2months after intervention. Method of measurement: Depression Anxiety and Stress Scales. Iran University of Medical Sciences Approved 2020-12-07 Ethics committee of Iran University of Medical Sciences Hemmat Highway between Chamran and Sheikh Fazlollah Iran University of Medical Sciences Headquarters Fifth Floor tehran Tehran Iran (Islamic Republic of)