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IRCT20231029059893N1 IRCT 2023-11-25 Shiraz university Comparing the effect of "inference-based therapy and treatment with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors" on obsessive-compulsive disorder The Effectiveness of Inference-based Therapy Combined with Pharmacotherapy with Selective Serotonin Reuptake Inhibitors Compared to Selective Serotonin Reuptake Inhibitors Monotherapy in Treating Patients with Obsessive-Compulsive Disorder with Good Insight 2023-11-11 anticipated 40 Complete https://irct.ir/trial/73437 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 Obsessive Compulsive Disorder. Intervention 1: First intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors and inference-based therapy Inference-based therapy is a cognitive therapy that takes place in 24 sessions of 45 minutes over 6 months. The focus of this therapy is on resolving obsessive doubt by overcoming the process of inferential confusion. To this end, during treatment, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques. Inference-based therapy consists of 3 basic steps: Education, Interventions & Consolidation. The Education phase consists of 4 steps: 1. Educating that most of OCD symptoms are caused by doubt 2. Focusing on reasoning before doubt (inferential confusion) and showing clients that doubt or obsession does not arise without a prelude 3. Exploring how obsessive doubt derives its power and value from a compelling narrative that logically leads to doubt 4. Addressing the selectivity nature of obsessions in OCD by introducing the construct of feared self. The intervention phase consists of: 1. Demonstrating the client that there is no direct here-and-now evidence that would support the OCD doubt & therefore, the OCD story is produced entirely subjectively 2. Demonstrating the client that since obsessive doubt arises purely from within the person and not an external source, it is %100 irrelevant to here and now 3. Assisting the client recognize the exact moment when they have left the world of senses and entered the realm of imagination 4. Describing how obsessive doubt is always false -due to its opposition to reality And finally, the Consolidation phase:1. Encouraging the client to narrate a non-obsessive story 2.Introducing the client to many OCD tricks that make it seem as if the obsessive doubt is connected to reality. 3.Highlighting the selective nature of obsessive doubt besides the vulnerable self-theme that exists in doubt 4. Moving towards a life without OCD, developing a method to enable maintenance of gains and prevention of relapse. Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life. Intervention 2: Second intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life. No - There is not a plan to make this available Justification or reason for not sharing IPD is Despite attempts to anonymize data, there may be a risk of re-identification participants, which is unethical and violates the researcher's commitment to participants. There is also a concern that the original data may be valuable for the researcher's own future research.
public Samaneh Karbakhsh Ravari
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
Shiraz Iran (Islamic Republic of) ۸۴۳۳۴ - ۷۱۹۴۶ +98 71 3613 4000 samaneh.karbakhsh@hafez.shirazu.ac.ir Shiraz University scientific Samaneh Karbakhsh Ravari
Faculty of Educational Sciences and Psychology,Shiraz University, Eram Square,daneshjoo Boulevard
Shiraz Iran (Islamic Republic of) 71946-84334 +98 71 3613 4000 samaneh.karbakhsh@hafez.shirazu.ac.ir Shiraz University Iran (Islamic Republic of) A primary diagnosis of obsessive compulsive disorder with good insight Minimum level of education :High school diploma Age between 18 to 50 Absence of suicidal risk/ current suicidal ideation 18 years 50 years Both current substance abuse comorbid personality disorders, psychotic disorders, an organic mental disorder, a pervasive developmental disorder or mental retardation evidence or diagnosis of bipolar disorder. F42.2 Mixed obsessional thoughts and acts Treatment - Other Treatment - Other First intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors and inference-based therapy Inference-based therapy is a cognitive therapy that takes place in 24 sessions of 45 minutes over 6 months. The focus of this therapy is on resolving obsessive doubt by overcoming the process of inferential confusion. To this end, during treatment, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques. Inference-based therapy consists of 3 basic steps: Education, Interventions & Consolidation. The Education phase consists of 4 steps: 1. Educating that most of OCD symptoms are caused by doubt 2. Focusing on reasoning before doubt (inferential confusion) and showing clients that doubt or obsession does not arise without a prelude 3. Exploring how obsessive doubt derives its power and value from a compelling narrative that logically leads to doubt 4. Addressing the selectivity nature of obsessions in OCD by introducing the construct of feared self. The intervention phase consists of: 1. Demonstrating the client that there is no direct here-and-now evidence that would support the OCD doubt & therefore, the OCD story is produced entirely subjectively 2. Demonstrating the client that since obsessive doubt arises purely from within the person and not an external source, it is %100 irrelevant to here and now 3. Assisting the client recognize the exact moment when they have left the world of senses and entered the realm of imagination 4. Describing how obsessive doubt is always false -due to its opposition to reality And finally, the Consolidation phase:1. Encouraging the client to narrate a non-obsessive story 2.Introducing the client to many OCD tricks that make it seem as if the obsessive doubt is connected to reality. 3.Highlighting the selective nature of obsessive doubt besides the vulnerable self-theme that exists in doubt 4. Moving towards a life without OCD, developing a method to enable maintenance of gains and prevention of relapse. Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life. Second intervention group: Pharmacotherapy with selective serotonin reuptake inhibitors Pharmacotherapy was performed with three drugs, fluoxetine(ABIDI), sertraline(ABIDI), and fluvoxamine(Tehrandarou), which are FDA-approved for the treatment of OCD in terms of effectiveness and side effects. To minimize the side effects of the drugs, such as gastrointestinal side effects, dizziness, and other symptoms, treatment with SSRIs was started at a very low dose and over time, depending on the patient's tolerance to the drug side effects, the dose of the drugs was increased by the psychiatrist every 4-7 days until the target dose was achieved. A specific dose has been considered for each of the 4 drugs used: Recommended dose of sertraline: 50 to 200 mg per day Recommended dose of fluoxetine: 20 to 60 mg per day Recommended dose of fluvoxamine: 100 to 300 mg per day All drugs were used once a day, except for fluvoxamine, which was used twice a day due to its short half-life. The patient's score on Yale-Brown Obsessive-Compulsive Scale. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Yale-Brown Obsessive-Compulsive Scale. The patient's score on the World Health Organization Quality of Life questionnaire - brief version. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: World Health Organization Quality of Life questionnaire - brief version. The patient's score on Beck Depression Inventory. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Beck Depression Inventory. The patient's score on Beck Anxiety Inventory. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Beck Anxiety Inventory. The patient's score on Inferential Confusion Questionnaire, Extended Version. Timepoint: Before the start of the intervention and after the end of the intervention. Method of measurement: Inferential Confusion Questionnaire, Extended Version. Shiraz University of Medical Sciences Shiraz university Shiraz University of Medical Sciences Approved 2023-04-18 Ethics committee of Faculty of Education and Psychology -Shiraz University Faculty of Education and Psychology, Shiraz University, Eram Square, Daneshjoo Blvd Shiraz Fars Iran (Islamic Republic of)