History
# Registration date Revision Id
3 2026-04-05, 1405/01/16 374840
2 2025-10-01, 1404/07/09 358439
1 2023-11-25, 1402/09/04 286284
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  • Protocol summary

    The current study aims to compare the effectiveness of two drug therapy with selective serotonin reuptake inhibitors and inference based therapy on the recovery of patients with obsessive-compulsive disorder with good insight.
    The present study aims to compare the effectiveness of "inference-based therapy in combination with pharmacotherapy with selective serotonin reuptake inhibitors " to "selective serotonin reuptake inhibitors monotherapy" in the treatment of patients with obsessive-compulsive disorder with good insight.
    پژوهش حاضر قصد دارد تا به مقایسه اثربخشي دو درمان دارویي با مهارکننده های انتخابي بازجذب سروتونین و درمان مبتني براستنتاج بر بهبودی بیماران مبتلا به اخت لال وسواسي اجباری با بینش قوی بپردازد.
    پژوهش حاضر قصد دارد تا به مقایسه اثربخشي "درمان مبتنی بر استنتاج در ترکیب با دارودرمانی با مهارکننده های انتخابی بازجذب سروتونین" با "مونوتراپی مهارکننده های انتخابی بازجذب سروتونین" در درمان بیماران مبتلا به اختلال وسواسي اجباری با بینش قوی بپردازد.
    A controlled clinical trial, with parallel groups, purposive sampling, phase 3 on 45 patients. Simple randomization was done.
    A clinical trial, with parallel groups, purposive sampling, phase 2 on 40 patients. Simple randomization was done.
    کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، نمونه گیری هدفمند، فاز 3 بر روی 45 بیمار. تصادفی سازی ساده صورت گرفت.
    کارآزمایی بالینی، با گروه های موازی، نمونه گیری هدفمند، فاز 2 بر روی 40 بیمار. تصادفی سازی ساده صورت گرفت.
    The trial is conducted at the hospital. SSRI within the dose range approved by the Food and Drug Organization of the country starts from the lowest dose and gradually increases. Inference-based therapy is also applied based on the IBT protocol during 12 sessions of 45 minutes.
    The trial was conducted at Ebnesina Hospital in Shiraz. Participants were treated in two treatment groups. SSRIs were started at the lowest dose within the FDA-approved dose range and gradually increased, and three drugs were used: fluoxetine (ABIDI), sertraline (ABIDI), and fluvoxamine (Tehrandaru). IBT was also applied based on the IBT protocol during 24 45-minute sessions. The focus of this therapy is on eliminating obsessive doubt by overcoming the inferential confusion process. For this purpose, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques during treatment. Inference-based therapy consists of 3 basic stages: education, intervention, and stabilization.
    کارآزمایی در محل بیمارستان انجام می شود. SSRI در محدوده دوز تایید شده توسط سازمان غذا و داروی کشور از پایینترین دوز شروع شده و به تدریج افزایش می یابد. درمان مبتنی بر استنتاج نیز براساس پروتکل IBT در طی 12 جلسه 45 دقیقه ای اعمال می شود.
    کارآزمایی در محل بیمارستان ابن سینای شهرستان شیراز انجام شد. شرکت کنندگان در قالب دو گروه درمانی تحت درمان قرار گرفتند. SSRIs در محدوده دوز تایید شده توسط FDA از پایینترین دوز شروع شده و به تدریج افزایش یافتند و از سه داروی فلوکسیتین(عبیدی)، سرترالین(عبیدی) و فلووکسامین(تهران دارو) استفاده گردید. درمان مبتنی بر استنتاج نیز براساس پروتکل IBT در طی 24 جلسه 45 دقیقه ای اعمال شد. تمرکز این درمان بر رفع شک وسواسی ازطریق غلبه بر فرآیند آشفتگی استنتاجی است.بدین منظور بیماران در طی درمان از طریق تکنیک های درمانی شروع به تغییر روایت های وسواسی خود به روایت های غیر وسواسی می نمایند. درمان مبتنی بر استنتاج از 3 مرحله اساسی آموزش،مداخله و تثبیت تشکیل می شود.
    inclusion criteria: at least third middle school education, no diagnosis of psychotic disorders, no use of psychiatric drugs, no chronic physical illness, age range from 18 to 60 years, and voluntary consent of the patient. exclusion criteria: comorbidity with personality disorders, chronic physical illness, mental disability, and substance abuse.
    Inclusion criteria: 1. A primary diagnosis of OCD with good insight 2. Minimum level of education: High school diploma 3. Age between 18 to 50.4. Absence of suicidal risk/ current suicidal ideation. Exclusion criteria: 1. current Substance abuse 2. comorbid personality disorders, psychotic disorders, an organic mental disorder, a pervasive developmental disorder or mental retardation 3. evidence or diagnosis of bipolar disorder.
    ملاکهای ورود به پژوهش عبارتند از: حداقل تحصیلات سوم راهنمایي، فاقد تشخیص اختلالات سایكوتیک، عدم مصرف داروهای روانپزشكي ،فقدان بیماری جسمي مزمن، دامنه سني 18 تا 60 سال و رضایت داوطلبانه بیمار . ملاک های خروج از پژوهش عبارتند از: هم آیندی مرضي با اختلالات شخصیت، داشتن بیماری جسمي مزمن، ناتواني ذهني و سوء مصرف مواد .
    ملاک های ورود به پژوهش عبارتند از: 1.تشخیص اولیه اختلال وسواس فکری-عملی با بینش قوی ۲. حداقل سطح تحصیلات: دیپلم ۳. سن بین ۱۸ تا ۵۰ سال ۴. عدم وجود خطر خودکشی/افکار خودکشی در حال حاضر ملاک های عدم ورود به پژوهش عبارتند از: ۱. سوءمصرف فعلی مواد ۲. همبودی با اختلالات شخصیت ، اختلالات روان‌پریشی، اختلال روان عضوی، اختلال رشدی فراگیر یا عقب‌ماندگی ذهنی ۳. شواهد یا تشخیص اختلال دوقطبی.
    There are 3 levels of intervention: 1. Drug therapy with SSRI and inference-based therapy 2. Drug therapy with SSRI and placebo 3. Control or waiting list group, which receives none of the treatments and placebo.
    There were 2 levels of intervention: 1. Pharmacotherapy with SSRI and inference-based therapy 2. pharmacotherapy with SSRI
    3 سطح مداخله وجود دارد: 1. دارودرمانی با SSRI و درمان مبتنی بر استنتاج 2. دارودرمانی با SSRI و پلاسیبو 3. گروه کنترل یا لیست انتظار، که هیچ یک از درمان ها و دارونما را دریافت نمی کند.
    2 سطح مداخله وجود داشت: 1. دارودرمانی با SSRI و درمان مبتنی بر استنتاج 2. دارودرمانی با SSRI
    score on the Yale Brown Obsessive Compulsive Scale
    The severity of the obsessions and compulsions
    نمره فرد در مقیاس وسواسی اجباری ییل براون
    شدت وسواس ها و اجبارها
  • General information

    60
    50
    Randomized
    Not randomized
    Used
    Not used
    3
    2
    45
    40
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    40
    2024-05-09, 1403/02/20
    2024-11-20, 1403/08/30
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    2023-12-02, 1402/09/11
    empty
    2024-12-24, 1403/10/04
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    2025-06-27, 1404/04/06
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    Completion of the plan
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    تکمیل طرح
    Comparing the Effectiveness of Dug Therapy with Selective Serotonin Reuptake Inhibitors with Inferenced based Therapy Among Obsessive Compulsive Disorder Patients with Good Insight
    Comparing the effect of "inference-based therapy and treatment with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors" on obsessive-compulsive disorder
    مقایسه اثربخشي دارودرماني با مهارکننده های انتخابي بازجذب سروتونین با درمان مبتني بر استنتاج در بین مبتلایان به اختلال وسواسي- اجباری با بینش قوی
    مقایسه اثر " درمان مبتنی بر استنتاج و درمان با مهارکننده های انتخابی بازجذب سروتونین" با "مهارکننده های انتخابی بازجذب سروتونین" بر اختلال وسواس
    Comparing the Effectiveness of Dug Therapy with Selective Serotonin Reuptake Inhibitors with Inferenced based Therapy Among Obsessive Compulsive Disorder Patients with Good Insight
    Comparing the effectiveness of "inference based therapy combined with pharmacotherapy with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors monotherapy" on treatment of obsessive compulsive disorder patients with good insight
    مقایسه اثربخشي دارودرماني با مهارکننده های انتخابي بازجذب سروتونین با درمان مبتني بر استنتاج در بین مبتلایان به اختلال وسواسي- اجباری با بینش قوی
    مقایسه اثربخشی "درمان مبتنی بر استنتاج در ترکیب با دارودرمانی با مهارکننده‌های انتخابی بازجذب سروتونین" با "مونوتراپی مهارکننده‌های انتخابی بازجذب سروتونین" در درمان بیماران مبتلا به اختلال وسواس فکری-عملی با بینش قوی
    Obsessive Compulsive Disorder (OCD) Sufferers with Good Insight
    At least third middle school education
    No diagnosis of psychotic disorders
    Not taking psychiatric drugs
    Lack of chronic physical illness
    Age range from 18 to 60 years
    Voluntary consent of the patient
    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
    مبتلایان به اختلال وسواسی اجباری(OCD) با بینش قوی
    حداقل تحصیلات سوم راهنمایي
    فاقد تشخیص اختلالات سایكوتیک
    عدم مصرف داروهای روانپزشكي
    فقدان بیماری جسمي مزمن
    دامنه سني 18 تا 60 سال
    رضایت داوطلبانه بیمار
    تشخیص اولیه اختلال وسواس فکری عملی با بینش قوی
    حداقل مدرک تحصیلی: دیپلم
    دامنه سني 18 تا 50 سال
    عدم وجود خطر خودکشی/افکار خودکشی فعلی
    Comorbidity with personality disorders
    chronic physical illness
    mental disability
    drug abuse
    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.
    هم آیندی مرضي با اختلالات شخصیت
    داشتن بیماری جسمي مزمن
    ناتواني ذهني
    سوء مصرف مواد
    سوء مصرف فعلی مواد
    همبودی با اختلالات شخصیت ، اختلالات روان‌پریشی، اختلال روانی عضوی، اختلال تحولی فراگیر یا عقب‌ماندگی ذهنی
    شواهد یا تشخیص اختلال دوقطبی
    Among the obsessive-compulsive disorder sufferers with good insight, 45 people will be selected by purposive sampling and will be placed in three groups of (each group, 15 people) drug therapy and inference-based therapy, drug therapy and placebo, and the control group (waiting list) as a simple random replacement. .
    از میان مبتلایان به اختلال وسواس با بینش قوی، 45 نفر به شیوه نمونه گیری هدفمند انتخاب خواهد شد و به صورت جایگزیني تصادفي ساده در سه گروه (هرگروه، 15 نفر) دارودرماني و درمان مبتني بر استنتاج، دارو درماني و پلاسیبو و گروه کنترل(لیست انتظار) قرار خواهند گرفت.
  • Primary outcomes

    #1
    The patient's score on the Yale Brown Obsessive-Compulsive Scale
    The patient's score on Yale-Brown Obsessive-Compulsive Scale
    نمره فرد در مقیاس وسواسي- اجباری ییل براون
    نمره فرد در مقیاس وسواسی- اجباري ییل- براون
    مقیاس وسواسي اجباری ییل- براون
    مقیاس وسواسی- اجباري ییل- براون
  • Secondary outcomes

    #1
    The patient's score on the World Health Organization Quality of Life questionnaire
    The patient's score on the World Health Organization Quality of Life questionnaire - brief version
    نمره فرد در پرسشنامه کیفیت زندگي سازمان جهاني بهداشت
    نمره فرد در پرسشنامه کیفیت زندگي سازمان جهاني بهداشت-فرم کوتاه
    World Health Organization Quality of Life questionnaire
    World Health Organization Quality of Life questionnaire - brief version
    پرسشنامه کیفیت زندگي سازمان جهاني بهداشت
    پرسشنامه کیفیت زندگي سازمان جهاني بهداشت-فرم کوتاه
    #2
    empty
    The patient's score on Beck Depression Inventory
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    نمره فرد در پرسشنامه افسردگی بک
    empty
    Before the start of the intervention and after the end of the intervention
    empty
    قبل از شروع مداخله و بعد از اتمام مداخله
    empty
    Beck Depression Inventory
    empty
    پرسشنامه افسردگی بک
    #3
    empty
    The patient's score on Beck Anxiety Inventory
    empty
    نمره فرد در پرسشنامه اضطراب بک
    empty
    Before the start of the intervention and after the end of the intervention
    empty
    قبل از شروع مداخله و بعد از اتمام مداخله
    empty
    Beck Anxiety Inventory
    empty
    پرسشنامه اضطراب بک
    #4
    empty
    The patient's score on Inferential Confusion Questionnaire, Extended Version
    empty
    نمره فرد در نسخه بسط‎ یافته پرسشنامه سردرگمی استنتاجی
    empty
    Before the start of the intervention and after the end of the intervention
    empty
    قبل از شروع مداخله و بعد از اتمام مداخله
    empty
    Inferential Confusion Questionnaire, Extended Version
    empty
    نسخه بسط‎ یافته پرسشنامه سردرگمی استنتاجی
  • Intervention groups

    #1
    First intervention group: Drug therapy with SSRIs 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 treatment is on the concept of doubt and the process of inferential confusion, as well as providing therapy assignments at the end of each session to increase the effectiveness of the treatment. Drug therapy is done with sertraline tablets from the class of SSRI drugs. The chemical composition of this pill is in the form of hydrochloride. The dosage is 100 to 200 mg once or twice a day. The minimum usage time is 6 months.
    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.
    گروه مداخله اول: دارو درماني با SSRIs و درمان مبتني بر استنتاج درمان مبتنی بر استنتاج یک درمان شناختی است که در طی 24 جلسه 45 دقیقه طی 6 ماه برگزار می شود. تمرکز این درمان بر مفهوم شک و فرآیند آشفتگی استنتاجی و همچنین ارائه تکالیف درمانی در پایان هر جلسه برای افزایش اثربخشی بیشتر درمان است. دارو درمانی با قرص سرترالین از کلاس داروهای SSRI انجام میشود. ترکیب شیمیایی این قرص به صورت هیدروکلراید است. دوز مصرف 100 تا 200 میلی گرمف یک یا دو بار در روز است. حداقل زمان مصرف نیز 6 ماه می باشد.
    گروه مداخله اول: دارو درماني با مهارکننده های انتخابي بازجذب سروتونین و درمان مبتني بر استنتاج درمان مبتنی بر استنتاج یک درمان شناختی است که در طی 24 جلسه 45 دقیقه ای طی 6 ماه برگزار می شود. تمرکز این درمان بر رفع شک وسواسی ازطریق غلبه بر فرآیند آشفتگی استنتاجی است.بدین منظور بیماران در طی درمان از طریق تکنیک های درمانی شروع به تغییر روایت های وسواسی خود به روایت های غیر وسواسی می نمایند. درمان مبتنی بر استنتاج از 3 مرحله اساسی تشکیل می شود:آموزش،مداخله و تثبیت. بخش آموزش شامل 4 گام می گردد: 1. آموزش این نکته که بیشتر علائم اختلال وسواس فکری-عملی ناشی از شک و تردید است. 2. تمرکز بر استدلال قبل از شک (سردرگمی استنتاجی) و نشان دادن این نکته به مراجع که شک یا وسواس بدون مقدمه ایجاد نمی‌شود. 3. بررسی اینکه چگونه شک وسواسی قدرت و ارزش خود را از روایتی قانع‌کننده که منطقاً منجر به شک می‌شود، می‌گیرد 4. پرداختن به ماهیت انتخابی وسواس‌ها در OCD با معرفی سازه خودِ ترسیده. مرحله مداخله شامل: 1. نشان دادن به مراجع که هیچ مدرک مستقیمی در اینجا و اکنون وجود ندارد که شک وسواسی را تأیید کند و بنابراین، داستان وسواسی کاملاً ذهنی تولید می‌شود. 2. نشان دادن به مراجع که از آنجا که شک وسواسی صرفاً از درون فرد ناشی می‌شود و نه یک منبع خارجی، ۱۰۰٪ به اینجا و اکنون بی‌ربط است. 3. کمک به مراجع برای تشخیص لحظه دقیق خروج از دنیای حواس و ورود به قلمرو تخیل.4. توصیف اینکه چگونه شک وسواسی همیشه نادرست است - به دلیل مخالفت آن با واقعیت. و درنهایت، مرحله تثبیت: 1. تشویق مراجع به روایت داستانی غیر وسواسی. 2. آشناکردن مراجع با بسیاری از ترفندهای OCD که باعث می‌شود شک وسواسی به واقعیت مرتبط به نظر برسد. 3. برجسته کردن ماهیت انتخابی شک وسواسی علاوه بر خودمضمون آسیب‌پذیرِ موجود در شک.4. حرکت به سوی زندگی بدون OCD، ایجاد روشی برای حفظ دستاوردها و جلوگیری از عود. دارو درمانی با سه داروی فلوکستین(عبیدی)، سرترالین(عبیدی)، و فلووکسامین(تهران دارو) که ازلحاظ اثربخشی و عوارض جانبی مورد تایید FDA در زمینه درمان OCD هستند، انجام شد. برای کمینه‎ سازی عوارض جانبی داروها مانند عوارض گوارشی، سرگیجه و سایر علائم، درمان با SSRIs با دوز بسیار کم شروع شد و در طی زمان-باتوجه به تحمل بیمار نسبت به عوارض دارویی-، هر 7-4 روز یک‎بار دوز داروها توسط روانپزشک اضافه گردید تا دوز هدف حاصل می‎گردید. برای هر یک از 4 داروی مورد استفاده دوز مشخصی لحاظ شده است: دوز پیشنهادی سرترالین: 50 تا 200میلی گرم در شبانه روز دوز پیشنهادی فلوکستین: 20 تا 60 میلی گرم در شبانه روز دوز پیشنهادی فلووکسامین 100 تا 300 میلی گرم در شبانه روز تمام داروها به صورت یکبار در روز مورد استفاده واقع می شدند به استثنای فلووکسامین که باتوجه به این که نیمه عمر کوتاهی دارد، دوبار در روز مورد استفاده واقع می‎ گردید.
    #2
    Second intervention group: Drug therapy with SSRIs and placebo Drug therapy is done with sertraline tablets from the class of SSRI drugs. The chemical composition of this pill is in the form of hydrochloride. The dosage is 100 to 200 mg once or twice a day. The minimum usage time is 6 months. The placebo group will receive 24 sessions of 45 minutes without receiving treatment and inference-based treatment training will undergo formal psychotherapy.
    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.
    گروه مداخله دوم: دارو درماني با SSRIs و دارونما دارو درمانی با قرص سرترالین از کلاس داروهای SSRI انجام میشود. ترکیب شیمیایی این قرص به صورت هیدروکلراید است. دوز مصرف 100 تا 200 میلی گرمف یک یا دو بار در روز است. حداقل زمان مصرف نیز 6 ماه می باشد. گروه دریافت کننده دارونما 24 جلسه 45 دقیقه ای بدون دریافت درمان و آموزش های درمان مبتنی بر استنتاج به شکل صوری تحت روان درمانی قرار خواهند گرفت.
    گروه مداخله دوم: دارو درماني با مهارکننده های انتخابي بازجذب سروتونین دارو درمانی با سه داروی فلوکستین(عبیدی)، سرترالین(عبیدی)، و فلووکسامین(تهران دارو) که ازلحاظ اثربخشی و عوارض جانبی مورد تایید FDA در زمینه درمان OCD هستند، انجام شد. برای کمینه‎ سازی عوارض جانبی داروها مانند عوارض گوارشی، سرگیجه و سایر علائم، درمان با SSRIs با دوز بسیار کم شروع شد و در طی زمان-باتوجه به تحمل بیمار نسبت به عوارض دارویی-، هر 7-4 روز یک‎بار دوز داروها توسط روانپزشک اضافه گردید تا دوز هدف حاصل می‎گردید. برای هر یک از 4 داروی مورد استفاده دوز مشخصی لحاظ شده است: دوز پیشنهادی سرترالین: 50 تا 200میلی گرم در شبانه روز دوز پیشنهادی فلوکستین: 20 تا 60 میلی گرم در شبانه روز دوز پیشنهادی فلووکسامین 100 تا 300 میلی گرم در شبانه روز تمام داروها به صورت یکبار در روز مورد استفاده واقع می شدند به استثنای فلووکسامین که باتوجه به این که نیمه عمر کوتاهی دارد، دوبار در روز مورد استفاده واقع می‎ گردید.
    #3
    N/A
    empty
    Control group: Wait list and not receiving any type of treatment
    empty
    گروه کنترل: لیست انتظار و عدم دریافت هیچ یک از انواع درمان ها
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: Ebne Sina Hospital
    Name of recruitment center - Persian: بیمارستان ابن سینا
    Full name of responsible person - English: Samaneh Karbakhsh Ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Street address - English: next to Bostan 13 Aban, Hafez St.
    Street address - Persian: خیابان حافظ - جنب بوستان 13 ابان
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7144676541
    Phone: +98 71 3228 9604
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address: https://ebnesina.sums.ac.ir/
    Name of recruitment center - English: Ebne Sina Hospital
    Name of recruitment center - Persian: بیمارستان ابن سینا
    Full name of responsible person - English: Samaneh Karbakhsh Ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Street address - English: Ebne Sina Hospital, next to Bostan 13 Aban, Hafez St, Shiraz
    Street address - Persian: شیراز،خیابان حافظ - جنب بوستان 13 آبان، بیمارستان ابن سینا
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7144676541
    Phone: +98 71 3228 9604
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: shiraz university
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Mohammad hadi sadeghi
    Full name of responsible person - Persian: محمدهادی صادقی
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, Daneshjoo Boulevard
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Fax:
    Email: pr@shirazu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shiraz university
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Bahram Hemmatinejhad
    Full name of responsible person - Persian: بهرام همتی‌نژاد
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, Daneshjoo Boulevard
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Fax:
    Email: pr@shirazu.ac.ir
    Web page address:
    empty
    Yes
    100
    50
    Shiraz University of Medical Sciences
    Shiraz university
    دانشگاه علوم پزشکی شیراز
    دانشگاه شیراز
    #2

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamid Mohammadi
    Full name of responsible person - Persian: حمید محمدی
    Street address - English: Seventh Floor, Shiraz University of Medical Sciences Central Building, Next to the Red Crescent,Zand Ave, Shiraz
    Street address - Persian: شیراز - خیابان زند - جنب هلال احمر - ساختمان مرکزی دانشگاه علوم پزشکی شیراز - طبقه هفتم
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Country: Iran (Islamic Republic of)
    Postal code: 7134814336
    Phone: +98 71 3235 7282
    Fax:
    Email: vcrdep@sums.ac.ir
    Web page address:
    empty
    Yes
    empty
    50
    empty
    Public
    empty
    Domestic
    empty
    Academic
    empty
    Shiraz University of Medical Sciences
    empty
    دانشگاه علوم پزشکی شیراز
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: shiraz university
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: samaneh karbakhsh ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: phd student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.ori1364@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shiraz University
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Samaneh Karbakhsh Ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: shiraz university
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Samaneh Karbakhsh ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: Phd student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology,Shiraz University, Eram Square,daneshjoo Boulevard
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shiraz University
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Samaneh Karbakhsh Ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology,Shiraz University, Eram Square,daneshjoo Boulevard
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 71946-84334
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address:
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: shiraz university
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: samaneh karbakhsh ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: phd student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۸۴۳۳۴ - ۷۱۹۴۶
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.ori1364@gmail.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shiraz University
    Name of organization / entity - Persian: دانشگاه شیراز
    Full name of responsible person - English: Samaneh Karbakhsh Ravari
    Full name of responsible person - Persian: سمانه کاربخش راوری
    Position - English: PhD student
    Position - Persian: دانشجوی دکتری
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
    Street address - Persian: بلوار دانشجو، میدان ارم، دانشگاه شیراز، دانشکده علوم تربیتی و روانشناسی
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 71946-84334
    Phone: +98 71 3613 4000
    Mobile: +98 913 666 7448
    Fax:
    Email: elahe.dori1364@gmail.com
    Web page address:
  • Sharing plan

    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    Due to the fact that consent has not been obtained from the participants in the trial, the release schedule is not yet known.
    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.
    باتوجه به اینکه هنوز از شرکت کنندگان در کارآزمایی رضایت نامه ای برای این امر گرفته نشده است، برنامه انتشار آن هنوز مشخص نیست.
    با وجود تلاش برای ناشناس‌سازی داده‌ها، ممکن است خطر شناسایی مجدد شرکت‌کنندگان وجود داشته باشد که این امر اخلاقی نیست و تعهد محقق به شرکت‌کنندگان را نقض می‌کند. همچنین این نگرانی وجود دارد که داده‌های اولیه ممکن است برای تحقیقات آینده خود محقق ارزشمند باشند.

Protocol summary

Study aim
The present study aims to compare the effectiveness of "inference-based therapy in combination with pharmacotherapy with selective serotonin reuptake inhibitors " to "selective serotonin reuptake inhibitors monotherapy" in the treatment of patients with obsessive-compulsive disorder with good insight.
Design
A clinical trial, with parallel groups, purposive sampling, phase 2 on 40 patients. Simple randomization was done.
Settings and conduct
The trial was conducted at Ebnesina Hospital in Shiraz. Participants were treated in two treatment groups. SSRIs were started at the lowest dose within the FDA-approved dose range and gradually increased, and three drugs were used: fluoxetine (ABIDI), sertraline (ABIDI), and fluvoxamine (Tehrandaru). IBT was also applied based on the IBT protocol during 24 45-minute sessions. The focus of this therapy is on eliminating obsessive doubt by overcoming the inferential confusion process. For this purpose, patients begin to change their obsessive narratives to non-obsessive narratives through therapeutic techniques during treatment. Inference-based therapy consists of 3 basic stages: education, intervention, and stabilization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. A primary diagnosis of OCD with good insight 2. Minimum level of education: High school diploma 3. Age between 18 to 50.4. Absence of suicidal risk/ current suicidal ideation. Exclusion criteria: 1. current Substance abuse 2. comorbid personality disorders, psychotic disorders, an organic mental disorder, a pervasive developmental disorder or mental retardation 3. evidence or diagnosis of bipolar disorder.
Intervention groups
There were 2 levels of intervention: 1. Pharmacotherapy with SSRI and inference-based therapy 2. pharmacotherapy with SSRI
Main outcome variables
The severity of the obsessions and compulsions

General information

Reason for update
Completion of the plan
Acronym
IRCT registration information
IRCT registration number: IRCT20231029059893N1
Registration date: 2023-11-25, 1402/09/04
Registration timing: prospective

Last update: 2025-10-09, 1404/07/17
Update count: 2
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Samaneh Karbakhsh ravari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3372 3936
Email address
elahe.dori1364@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-11, 1402/08/20
Expected recruitment end date
2024-11-20, 1403/08/30
Actual recruitment start date
2023-12-02, 1402/09/11
Actual recruitment end date
2024-12-24, 1403/10/04
Trial completion date
2025-06-27, 1404/04/06
Scientific title
Comparing the effectiveness of "inference based therapy combined with pharmacotherapy with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors monotherapy" on treatment of obsessive compulsive disorder patients with good insight
Public title
Comparing the effect of "inference-based therapy and treatment with selective serotonin reuptake inhibitors" to "selective serotonin reuptake inhibitors" on obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Faculty of Education and Psychology -Shiraz University
Street address
Faculty of Education and Psychology, Shiraz University, Eram Square, Daneshjoo Blvd
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Approval date
2023-04-18, 1402/01/29
Ethics committee reference number
IR.US.PSYEDU.REC.1402.022

Health conditions studied

1

Description of health condition studied
Obsessive Compulsive Disorder
ICD-10 code
F42.2
ICD-10 code description
Mixed obsessional thoughts and acts

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
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

2

Description
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

3

Description
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

4

Description
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

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ebne Sina Hospital
Full name of responsible person
Samaneh Karbakhsh Ravari
Street address
Ebne Sina Hospital, next to Bostan 13 Aban, Hafez St, Shiraz
City
shiraz
Province
Fars
Postal code
7144676541
Phone
+98 71 3228 9604
Email
elahe.dori1364@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz university
Full name of responsible person
Bahram Hemmatinejhad
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, Daneshjoo Boulevard
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Email
pr@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz university
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Mohammadi
Street address
Seventh Floor, Shiraz University of Medical Sciences Central Building, Next to the Red Crescent,Zand Ave, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Samaneh Karbakhsh Ravari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
City
Shiraz
Province
Fars
Postal code
۸۴۳۳۴ - ۷۱۹۴۶
Phone
+98 71 3613 4000
Email
elahe.dori1364@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Samaneh Karbakhsh Ravari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology,Shiraz University, Eram Square,daneshjoo Boulevard
City
Shiraz
Province
Fars
Postal code
71946-84334
Phone
+98 71 3613 4000
Fax
Email
elahe.dori1364@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Samaneh Karbakhsh Ravari
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, Shiraz University, Eram Square, daneshjoo Boulevard,
City
Shiraz
Province
Fars
Postal code
71946-84334
Phone
+98 71 3613 4000
Email
elahe.dori1364@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
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.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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