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IRCT20210214050353N1 IRCT 2021-10-16 Iran University of Medical Sciences Comparison of the effectiveness of cognitive behavioral therapy using virtual reality-based exposure and response prevention ( VR - ERP ) and cognitive behavioral therapy in OCD Comparison of the effectiveness of cognitive behavioral therapy using virtual reality-based exposure and response prevention ( VR - ERP ) and cognitive behavioral therapy in adults with obsessive-compulsive disorder-contamination/washing 2021-10-04 anticipated 36 Complete https://irct.ir/trial/54374 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Restricted Randomization method of block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process, so that the number of samples assigned to each of the study groups become equal and in this study, we will have 4 blocks. Excel software was used to generate a random sequence. Allocation concealment is also used, which is the method used to execute a random sequence on study participants. In such a way that the assigned group is not known before the individual is assigned. 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: cognitive behavioral therapy using virtual reality-based exposure and response prevention (VR-ERP) therapy : At first, Participants will complete the questionnaires as a pre-test including: Yale-brown obsessive compulsive scale, Beck Depression Inventory, Beck Anxiety Inventory, Obsessive beliefs questionnaire-44, World Health Organization Disability Assessment Scale-2. Then, they enter the training phase to get used to moving in the virtual environment. In this stage, they encounter a natural environment in the living room and do a number of tasks such as check the room for a few minutes, turn on the TV, Move objects inside the shelves. Then, Then, they enter the experimental phase. This step includes 12 sessions. Individual treatment sessions are held weekly. Each session includes a discussion about the previous week's homework and an obsessive-compulsive self-assessment, cognitive reconstruction of maladaptive thoughts in 20 minutes and virtual reality exposure and response prevention in 25 to 45 minutes. Then next week's assignment, which includes reviewing educational materials, self-examination will be specified. The first two sessions focus on case conceptualization and the introduction of a treatment plan. Session 12 will be devoted to relapse prevention. Participants will then complete the questionnaires as a post-test. In follow-up phase, participants will complete the research questionnaires after 3 months. Intervention 2: Control group: Cognitive behavioral therapy: At first, Participants will complete the questionnaires as a pre-test including: Yale-brown obsessive compulsive scale, Beck Depression Inventory, Beck Anxiety Inventory, Obsessive beliefs questionnaire-44, World Health Organization Disability Assessment Scale-2. Then, they receive 12 sessions of cognitive-behavioral therapy. Individual treatment sessions are held weekly. Each session includes a discussion about the previous week's homework and an obsessive-compulsive self-assessment, cognitive reconstruction of maladaptive thoughts in 20 minutes and in-vivo or imaginal exposure and response prevention in 25 to 45 minutes. Then next week's assignment, which includes reviewing educational materials, self-examination will be specified. The first two sessions focus on case conceptualization and the introduction of a treatment plan. Session 12 will be devoted to relapse prevention. Participants will then complete the questionnaires as a post-test. In follow-up phase, participants will complete the research questionnaires after 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Razieh Javaheri Renani
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 razieh.javaheri@yahoo.com Iran University of Medical Sciences scientific Razieh Javaheri Renani
Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613111 +98 21 6655 1655 razieh.javaheri@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Adults with obsessive-compulsive disorder of the type of contamination / washing with mild, moderate and severe severity based on DSM-5 At least Diploma education Age between 18 to 50 years’ old 18 years 50 years Both Patients with psychiatric disorders including psychotic disorders, substance use disorder and bipolar disorder Patients with neurological, neurological disease and no history of seizures Patients with severe personality disorders including paranoid, schizoid, schizotypal, borderline, antisocial, narcissistic personality disorder Diagnostic criteria of obsessive-compulsive disorder of non-contamination / washing type including ordering, symmetry, checking F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other Intervention group: cognitive behavioral therapy using virtual reality-based exposure and response prevention (VR-ERP) therapy : At first, Participants will complete the questionnaires as a pre-test including: Yale-brown obsessive compulsive scale, Beck Depression Inventory, Beck Anxiety Inventory, Obsessive beliefs questionnaire-44, World Health Organization Disability Assessment Scale-2. Then, they enter the training phase to get used to moving in the virtual environment. In this stage, they encounter a natural environment in the living room and do a number of tasks such as check the room for a few minutes, turn on the TV, Move objects inside the shelves. Then, Then, they enter the experimental phase. This step includes 12 sessions. Individual treatment sessions are held weekly. Each session includes a discussion about the previous week's homework and an obsessive-compulsive self-assessment, cognitive reconstruction of maladaptive thoughts in 20 minutes and virtual reality exposure and response prevention in 25 to 45 minutes. Then next week's assignment, which includes reviewing educational materials, self-examination will be specified. The first two sessions focus on case conceptualization and the introduction of a treatment plan. Session 12 will be devoted to relapse prevention. Participants will then complete the questionnaires as a post-test. In follow-up phase, participants will complete the research questionnaires after 3 months. Control group: Cognitive behavioral therapy: At first, Participants will complete the questionnaires as a pre-test including: Yale-brown obsessive compulsive scale, Beck Depression Inventory, Beck Anxiety Inventory, Obsessive beliefs questionnaire-44, World Health Organization Disability Assessment Scale-2. Then, they receive 12 sessions of cognitive-behavioral therapy. Individual treatment sessions are held weekly. Each session includes a discussion about the previous week's homework and an obsessive-compulsive self-assessment, cognitive reconstruction of maladaptive thoughts in 20 minutes and in-vivo or imaginal exposure and response prevention in 25 to 45 minutes. Then next week's assignment, which includes reviewing educational materials, self-examination will be specified. The first two sessions focus on case conceptualization and the introduction of a treatment plan. Session 12 will be devoted to relapse prevention. Participants will then complete the questionnaires as a post-test. In follow-up phase, participants will complete the research questionnaires after 3 months. Severity of signs and symptoms in patients with obsessive-compulsive disorder. Timepoint: before the intervention, last session, 3 months after the intervention. Method of measurement: Yale-brown obsessive compulsive scale. The symptoms of depression. Timepoint: before the intervention, last session, 3 months after intervention. Method of measurement: Beck Depression Inventory. The symptoms of anxiety. Timepoint: before the intervention, last session, 3 months after intervention. Method of measurement: Beck Anxiety Inventory. Obsessive beliefs. Timepoint: before the intervention, last session, 3 months after intervention. Method of measurement: Obsessive Beliefs Questionnaire-44. Disability. Timepoint: before the intervention, last session, 3 months after intervention. Method of measurement: World Health Organization Disability Assessment Scale-2. Iran University of Medical Sciences Approved 2021-09-28 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, fifth floor Tehran Tehran Iran (Islamic Republic of)