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IRCT20230719058848N1 IRCT 2023-08-28 Zanjan University of Medical Sciences The Effectiveness of Combined Acceptance and Commitment Therapy and Exposure and Response Prevention on Obsessive-Compulsive Disorder The Effectiveness of Combined Acceptance and Commitment Therapy and Exposure and Response Prevention on OCD Symptom Reduction and Related Psychological Factors in Patients with Obsessive-Compulsive Disorder 2023-09-20 anticipated 40 Complete https://irct.ir/trial/71556 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation is done using Excel software. For this, in the first column, we enter 20 numbers 1 and 20 numbers 2 (representing the test and control group, respectively). Then, in the second column, we generate 40 random numbers using the (RAND) function. We sort the data based on column values containing random numbers (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups, Blinding description: In the implementation of this study, blinding will be done in such a way that the therapist and the evaluator are two different people, the therapist is the student, and the evaluator will be a clinical psychology graduate who will not know about the people of both groups in the process of evaluating the occurrence of consequences and reduction of symptoms before and after treatment and also during the follow-up period. N/A Obsessive compulsive disorder. Intervention 1: Intervention group: Including 20 patients with obsessive-compulsive disorder who will receive the combined treatment protocol of ACT and ERP written by Twohig et al. (2011) twice a week for 16 sessions and each session for 120 minutes. And they are evaluated before the start of the intervention, after its completion and 3 months after its completion. The aforementioned treatment protocol combines the two treatments of acceptance and commitment and exposure and response prevention in order to improve the symptoms of obsessive-compulsive disorder and requires that people attend the treatment until the end of 16 sessions in order to achieve therapeutic effects. The tools needed in this treatment are the homework worksheets, which clients are expected to do the exercises at home in addition to doing the exercises in the treatment session and write in the worksheets. Acceptance and commitment therapy includes 6 components: acceptance, living in the present moment, cognitive diffusion, self as context, values, and committed action, these 6 components are the basis of the structure of a main component called psychological flexibility, and the goal of this treatment is to achieve psychological flexibility. In Exposure and response prevention, people are exposed to the anxiety-provoking stimuluses according to the pre-determined hierarchy, and they are also prevented from wanting to engage in their past avoidant or additional behaviors in response to these stimuluses. The process continues and repeats until the person's anxiety is reduced when exposing the said stimuluses. Intervention 2: Control group: Including 20 patients with obsessive-compulsive disorder who do not receive any intervention during the study and are placed on the waiting list to receive the combined ACT and ERP treatment protocol written by Twohig et al. (2011) twice a week for 16 sessions and each session for 120 minutes after the research completion. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Seyyede Elnaz Mousavi
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 elnaz48.mousavi@gmail.com Zanjan University of Medical Sciences scientific Dr. Seyyede Elnaz Mousavi
Department of Clinical Psychology, Dr. Beheshti Psychiatric Hospital, Ark Square
Zanjan Iran (Islamic Republic of) 4513615788 +98 24 3354 4001 elnaz48.mousavi@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) having symptoms of obsessive-compulsive disorder based on the interview (SCID-I, II) and obtaining a score of at least 21 in the OCI-R questionnaire. Age range between 18-60 years. Having a diploma or higher education. Participants` interest to participate in the research based on the provisions of the written consent. 18 years 60 years Both Suffering from severe depression (score ≥ 24 on the Hamilton Depression Inventory), bipolar disorder spectrum, psychotic spectrum disorder, or borderline or schizotypal personality disorder. Drug and alcohol consumption in the last three months. Participation in previous formal ERP or ACT trials for OCD. Taking psychiatric drugs. F42 Obsessive-compulsive disorder Treatment - Other Treatment - Other Intervention group: Including 20 patients with obsessive-compulsive disorder who will receive the combined treatment protocol of ACT and ERP written by Twohig et al. (2011) twice a week for 16 sessions and each session for 120 minutes. And they are evaluated before the start of the intervention, after its completion and 3 months after its completion. The aforementioned treatment protocol combines the two treatments of acceptance and commitment and exposure and response prevention in order to improve the symptoms of obsessive-compulsive disorder and requires that people attend the treatment until the end of 16 sessions in order to achieve therapeutic effects. The tools needed in this treatment are the homework worksheets, which clients are expected to do the exercises at home in addition to doing the exercises in the treatment session and write in the worksheets. Acceptance and commitment therapy includes 6 components: acceptance, living in the present moment, cognitive diffusion, self as context, values, and committed action, these 6 components are the basis of the structure of a main component called psychological flexibility, and the goal of this treatment is to achieve psychological flexibility. In Exposure and response prevention, people are exposed to the anxiety-provoking stimuluses according to the pre-determined hierarchy, and they are also prevented from wanting to engage in their past avoidant or additional behaviors in response to these stimuluses. The process continues and repeats until the person's anxiety is reduced when exposing the said stimuluses. Control group: Including 20 patients with obsessive-compulsive disorder who do not receive any intervention during the study and are placed on the waiting list to receive the combined ACT and ERP treatment protocol written by Twohig et al. (2011) twice a week for 16 sessions and each session for 120 minutes after the research completion. Obsessive-compulsive disorder score in OCI-R questionnaire. Timepoint: Before the start of the intervention, after the end of the intervention, 3 .months after the end of the intervention. Method of measurement: Obsessive-Compulsive Inventory-Revised (OCI-R). Psychological flexibility score. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Acceptance and Action Questionnaire-II (AAQ-II). Experiential avoidance score. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Acceptance and Action Questionnaire-II (AAQ-II). Cognitive fusion score. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Cognitive Fusion Questionnaire-7 (CFQ). Interpretation of intrusions score. Timepoint: Before the start of the intervention, after the end of the intervention, 3 months after the end of the intervention. Method of measurement: Interpretation of Intrusions Inventory-31 (III-31). Zanjan University of Medical Sciences Approved 2023-07-18 Ethics committee of Zanjan University of Medical Sciences Dr. Beheshti Psychiatric Hospital, Ark Square Zanjan Zanjan Iran (Islamic Republic of)