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The effectiveness of Modified Mindfulness-based Cognitive Therapy for hospitalized Children Hospitalized with Cancer compared to control group in attention problems and internalizing problems.

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History
# Registration date Revision Id
3 2020-08-08, 1399/05/18 165655
2 2013-12-06, 1392/09/15 14018
1
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  • Protocol summary

    This study aimed to investigate the effectiveness of mindfulness based cognitive therapy on improvement of adjustment in hospitalized children with cancer. Entry criteria to study included not receiving psychological therapy for at least one month before participating in the study, having a minimum age of 9 and maximum age of 13 years and staying at least 3 week in hospital. The sample included 33 children with cancer who were randomly assigned to experimental (17 case) and control (16 case) groups. Children in experimental group were trained in 15 sessions of 45 minutes during one month. Findings revealed that mindfulness based cognitive therapy can leads to improvement in children’s psycho-social adjustment in hospitalized children with cancer.
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    ااین مطالعه با هدف بررسی اثربخشی شناخت درمانی مبتنی بر ذهن آگاهی بربهبود و ارتقاء سازگاری کودکان مبتلا به سرطان بستری در بیمارستان انجام شده است. ملاك‌هاي ورود به پژوهش عبارت بودند از عدم دريافت درمان‌هاي روانشناختي حداقل به مدت یک ماه قبل از ورود به پژوهش، عدم مصرف داروهای روانپزشکی حداقل به مدت یکماه قبل از ورود به پژوهش، داشتن سن حداقل 9 سال و حداكثر 13 سال. گروه نمونه شامل33 کودک مبتلا به سرطان بودند که به طور تصادفی به دو گروه آزما یش (17 نفر) و کنترل (16 نفر) اختصاص یافتند. کودکان گروه آزمایشی 15 جلسه در طی یک ماه به مدت 45 دقیقه به صورت گروهی آموزش دیدند. فرض بر آن است که شناخت درمانی مبتنی بر ذهن آگاهی بتواند منجر به بهبود سازگاری روانی-اجتماعی کودکان گردد.
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    The aim of this study is the enhancement of emotional regulation in children with cancer.
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    هدف پژوهش تنظیم هیجانی در کودکان مبتلا به سرطان است.
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    Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45-minutes. Sessions were conducted 5 times weekly for 4 weeks.
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    چهل کودک (از سن 11 تا 13) که تشخیص سرطان دریافت کرده بودند به صورت تصادفی به گروه آزمایش و کنترل تقسیم شدند و هر کدام از گروهها بیست نفر عضو داشتند. علت تغییر دادن پروتکل ذهن آگاهی، سازگار کردن پروتکل درمانی با نیازهای خاص کودکان بستری شده در بیمارستان بود. ما جلسات را به بیست جلسه 45 دقیقه ای برای 4 هفته تغییر دادیم.
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    The study was conducted at the Mahak Hospital and Rehabilitation Complex. located in Tehran, Iran.
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    تحقیق در مجتمع بیمارستانی و توانبخشی محک انجام شدکه در تهران واقع شده است.
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    Hospitalized patients were eligible to participate in the MBCT-C if they were 11 to 13 years of age Patients who were determined to be diagnosed with a terminal illness were excluded.
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    کودکان بستری در بیمارستانی قادر به شرکت در این تحقیق بودند که دارای سن 11 الی 13 سال بودند و بیمارانی که به عنوان یک بیمار در مراحل آخر سرطان تشخیص داده شده باشد، از تحقیق خارج شدند.
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    The primary aim of MBCT-C is to improve effective self-regulation through the development of mindful attention and to decenter from thoughts and emotions. The main component of this therapy is awareness of the present moment, which helps them decide more wisely. Unlike cognitive therapy, no effort is made to restructure or change existing thoughts and emotions. Individuals in this program learn to be mindful in daily life. The control group was 20 children with cancer hospitalized and were not under any psychological and psychiatric therapy.
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    هدف از درمان ذهن آگاهی بهبود کنترل توجه و توجه به زمان حال می باشد. در گروه آزمایش به کودکان تمرین های مختلف شناخت درمانی و ذهن آگاهی اموزش داده شد. این آگاهی به آنها کمک می کند تا از اصول شناخت درمانی برای هوشیاری بیشتر و تصمیمات دلسوزانه جهت پاسخ دهی به رویدادها در هر لحظه استفاده کنند.اعضای گروه کنترل نیز بیست نفر از کودکان مبتلا به سرطان دارای شرایط ورود بودند که تحت تاثیر هیچ مداخله روانشناختی و روانپزشکی نبودند.
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    Change in internalizing and attention problems.
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    تغییر در مشكلات دروني سازی و توجه.

  • General information

    9
    11
    33
    40
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    40
    2012-09-22, 1391/07/01
    2013-09-01, 1392/06/10
    2013-03-19, 1391/12/29
    2014-03-11, 1392/12/20
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    2013-08-31, 1392/06/09
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    2014-03-10, 1392/12/19
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    2014-03-10, 1392/12/19
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    Mindfulness-Based Cognitive Therapy has been focused on the reduction in internalizing and attention problems as well as enhancement in emotional regulation. So, we decided to assess the variables which had more support in the literature review. We selected internalizing and attention problems because more studies examined them. Moreover, we found out in hospitalized children who could stay in the hospital for one month, internalizing and attention problems are more evident than adjustment problems. Hence, we decided to change the independent variable from adjustment to attention and internalizing problems. Besides, parents in the initial interviews reported that their children's internalizing and attention problems are more frequent than the adjustment problems. It became another reason to change the "adjustment" variable to the internalizing and attention issues.
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    به دلیل اینکه شناخت درمانی مبتنی بر ذهن آگاهی به صورت متمرکز بر روی کاهش مشکلات افسردگی و اضطراب و بهبود مهارت های کنترل هیجانی و کنترل توجه ساخته شده بود و پشتوانه پژوهشی که تایید کننده اثر بخشی این پروتکل برای مشکلات درونی سازی و توجه باشد نسبت به اثربخشی در مورد مشکلات سازگاری بیشتر بود ما تصمیم گرفتیم به جای بررسی سازگاری به بررسی مشکلات درونی سازی و توجه بپردازیم. همچنین در کودکان بستری در بیمارستان ما تنها دسترسی به آنها به مدت یک ماه را داشتیم چون احتمال داشت آنها زودتر مرخص شوند و بررسی علایم مشهود تر چون اضطراب، افسردگی، مشکلات توجه و جسمانی سازی در آنها امکان پذیر تر بود ما تصمیم گرفتیم که متغیر وابسته را از سازگاری به مشکلات درونی سازی و توجه تغییر دهیم. علاوه بر این براساس بررسی اولیه ما در مصاحبه اولیه با والدین آنها مشکلات اضطراب و همچنین جسمانی سازی در آنها بیشتر بود نسبت به مشکلات سازگاری بنابراین ما اولویت را به مشکلات درونی سازی و توجه دادیم.
    The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Internalizing and Attention Problems in Children with Cancer
    The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Children with Cancer
    اثربخشی شناخت درمانی مبتنی بر ذهن آگاهی بر کاهش مشکلات درونی سازی و مشکلات توجه کودکان مبتلا به سرطان
    اثربخشی شناخت درمانی مبتنی بر ذهن آگاهی سازگار شده برای کودکان مبتلا به سرطان
    The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Internalizing and Attention Problems in Children with Cancer
    The effectiveness of Modified Mindfulness-based Cognitive Therapy for hospitalized Children Hospitalized with Cancer compared to control group in attention problems and internalizing problems.
    اثربخشی شناخت درمانی مبتنی بر ذهن آگاهی برای مشکلات درونی سازی و توجه کودکان مبتلا به سرطان
    اثربخشی شناخت درمانی مبتنی بر ذهن آگاهی تغییر شکل یافته بر بهبود مشکلات توجه و درونی سازی در کودکان مبتلا به سرطان بستری در بیمارستان در مقایسه با گروه کنترل
    Hospitalized patients were eligible to participate in the Mindfulness-Based Cognitive Therapy for Children (MBCT-C) program in addition to receiving TAU if they were (a) 11 to 13 years of age; (b) had at least average fluency in Persian; (c) had received the first diagnosis of any type of cancer except brain cancers; (d) were undergoing radiation therapy and/or chemotherapy through the hospital’s oncology division; and (e) had not received any psychological interventions or psychiatric medications in the six months preceding the study. Diagnostic inclusion criteria were: (f) a diagnosis of Autism spectrum disorder (ASD) (Diagnostic and Statistical Manual of Mental Disorders (IV) (DSM-IV (American Psychiatric Association, 2000); and (g) at least two comorbid diagnoses in any of four diagnostic categories (anxiety, depression, psychosomatic, or attention deficit disorders). Diagnoses were ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Persian version (K-SADS-PL-P). Additionally, patients needed to be: (h) in the borderline or clinical range for internalizing problems (T-score ≥ 60) and attention problems (T-score ≥ 57) on at least two of four subscales of the Child Behavior Checklist (CBCL) or Youth Self-Report (YSR )(depression/anxiety, withdrawal/depression, somatic complaints, and attention problems) at the screening assessment.
    کودکان بستری در بیمارستانی قادر به شرکت در این تحقیق بودند که علاوه بر شرکت در برنامه های عادی بیمارستان دارای: الف) سن 11 الی 13 سال بودند (ب) حداقل توانایی صحبت روان به زبان فارسی را دارا بودند (ج) اولین تشخیص سرطان را دریافت کرده باشند به جز تومور مغزی (د) دریافت کننده اکنونی رادیوتراپی یا شیمی درمانی در بخش سرطان بیمارستان باشند (ت) در شش ماه گذشته خدمات روانشناختی یا روانپزشکی دریافت نکرده باشد و معیارهای ورودی تشخیصی شامل (ث) ASD(براساس معیارهای تشخیصی انجمن روانپزشکی آمریکا-چاپ پنجم، 2000) و (ح) حداقل دو تشخیص همزمان از چهار دسته بندی (اضطراب، افسردگی، روان تنی، و اختلالات نقص توجه) دارا باشند. تشخيص ها با استفاده از برنامه Kiddie برای اختلالات عاطفی و اسکیزوفرنی- نسخه فعلی و طول زندگی به زبان فارسی (K-SADS-PL-P) بررسی شد. علاوه بر این ، بیماران نیاز داشتند (ه) در دامنه مرزی یا بالینی برای مشکلات درونی سازی (نمرهT بزرگتر یا مساوی با 60) و مشکلات توجه (نمره Tبزرگتر یا مساوی با 57) در حداقل دو از چهار خرده مقیاس چک لیست مشکلات رفتاری کودکان آخنباخ یا در فرم خود گزارشی نوجوانان آحنباخ (افسردگی / اضطراب ، ترک / افسردگی ، شکایات جسمی و مشکلات توجه) در ارزیابی غربالگری داشته باشند.
    Patients who were determined to (i) have a major cognitive dysfunction or developmental disability, or (j) was diagnosed with a terminal illness (defined as having a prognosis of fewer than six months) were excluded. Moreover, Brain cancers were excluded based on research suggesting that these may affect attention (Raghubar et al., 2017), a key outcome variable.
    بیمارانی که دارای: (الف) اختلالات اساسی شناختی یا ناتوانایی های رشدی یا (ب) به عنوان یک بیمار در مراحل آخر سرطان تشخیص داده شده باشد. (تعریف می شود به عنوان کسی که پیش آگهی زنده ماندنش کمتر از شش ماه است) از تحقیق خارج شدند. و همچنین بیمارانی که دارای تومور مغزی بودند چون این مسئله می تواند داده های اصلی مورد ازمایش را تحت تاثیر قرار دهد از تحقیق خارج شدند.
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    We utilized simple randomization through the excel file of random numbers. The unit of randomization was individual.
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    برای تصادفی سازی از جدول اعداد تصادفی اکسل استفاده شد. روش تصادفی ساده بود و هر یک از افراد نمونه به دو گروه کنترل و ازمایش تقسیم شدند. واحد تصادفی سازی فردی بود.
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  • Health conditions studied

    #1
    F43.2
    F06.30
    Adjustment disorders
    Mood disorder due to known physiological condition, unspecified
    Adjustment
    cancer
    سازگاری
    سرطان
    #2
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    F06.4
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    Anxiety disorder due to known physiological condition
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    anxiety
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    اضطراب
    #3
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    F06.31
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    Mood disorder due to known physiological condition with depressive features
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    depression
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    افسردگی
    #4
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    F06.4
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    Anxiety disorder due to known physiological condition
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    somatic complaints
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    جسمانی سازی
    #5
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    F90
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    Attention-deficit hyperactivity disorders
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    attention problems
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    مشکلات توجه

  • Primary outcomes

    #1
    Psychosocial Adjustment
    internalizing and attention problems
    سازگاری روانی-اجتماعی
    تاثیر بر مشکلات درونی سازی و مشکلات توجه
    Before and 3 weeks of treatment
    Before and 4 weeks after the treatment as well as 2-month follow-up
    قبل از مداخله و سه هفته بعد از شروع مداخله
    قبل از مداخله و چهار هفته بعد از شروع مداخله و هم چنین دو ماه بعد از ارزیابی بعد از درمان (به عنوان ارزیابی پیگیری).
    Child Behavior Check List
    CBCL and YSR
    سیاهه رفتار کودک، فرم والد
    سیاهه رفتار کودک، فرم والد و خود گزارشی نوجوان

  • Secondary outcomes

    #1
    More cooperation in medical treatments
    more cooperation in medical treatments in participants
    همکاری کودک در درمانهای پزشکی
    تغییر در سطح همکاری کودک در درمانهای پزشکی
    Befor and after of treatment
    Before and after the treatment as well as at follow-up point
    قبل و بعد از مداخله
    قبل و بعد از مداخله و در زمان پیگیری دو ماهه.
    Interview
    Interviews
    مصاحبه با مادر کودک
    مصاحبه با والد

  • Intervention groups

    #1
    Other
    Treatment - Other
    Experimental group: Participants are 17 boys and girls aged 9‐13 that hospitalized because of cancer. They participated in 15-session program consisting of 45-minute group session per week, focused on mindfulness training.
    Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment as usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45 min. Sessions were conducted 5 times weekly for 4 weeks. Primary outcome measures were the Child Behavior Checklist, Parent Report and its companion instrument, and the Youth Self-Report (YSR). Data were collected at pre-intervention, post-intervention, and at 2 months following the intervention.
    گروه آزمایشی: در 15 جلسه آموزشی 45 دقیقه ای، طی سه هفته، تمرینهایی به منظور آموزش تئوری های مبتنی بر ذهن آگاهی بر روی کودکان انجام می شد
    گروه آزمایش: شامل بیست نفر بودند. در گروه آزمایش افراد به شش گروه کوچک تقسیم شدند. دو گروه که هر کدام 4 آزمودنی داشتند، سه گروه که سه آزمودنی داشتند و یک گروه که دو آزمودنی داشت (یکی از اعضای این گروه بعد از جلسه چهارم درمان را ادامه نداد). همه شش گروه توسط یک خانواده درمانگر هدایت میشدند که قبلا برای هدایت گروه درمانی ذهن آگاهی آموزش دیده بود و هم چنین در درمان کودکان تجربه داشت. هر جلسه به صورت صوتی ضبط می شد و هم چنین میزان وفاداری به پروتکل اصلی توسط روانشناس بالینی ناظر بررسی می شد و بازخورد های لازم به هدایتگر جلسات داده می شد. تعداد جلسات بیست جلسه 45 دقیقه ای بود که 5 بار در هفته به مدت یک ماه انجام شد. شناخت درمانی مبتنی بر ذهن آگاهی با الهام از پروتکل شناخت درمانی مبتنی بر ذهن اگاهی توسط لی و سمپل در سال 2011 انجام شد.
    #2
    Control group: Participants are boys and girls aged 9‐13 (n=16) that hospitalized because of cancer with medical cancer treatment as usual.
    Forty youth were age and gender-matched, and then randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). Mahak hospital provided some welfare services and social work services. Welfare services as well as social work services was equal for both experimental and control group. Social workers were assigned to accompany the child and help the family to become acquainted with the cancer, available services, hospital procedure and personnel, and disjunctive treatment. Moreover, they facilitated a shared playroom that every child welcomed to join. They could use from various toys there and made friend with others. Parents could accompany their children there. And the group was lead by social workers. The room was open 2 hours daily from 2 pm to 4 pm. Children could use from snacks there and remaining there was not mandatory.
    گروه کنترل: 16 نفر از کودکان مبتلا به سرطان 9 تا 13 ساله بدون دریافت مداخله ذهن آگاهی، در پیش آزمون و پس آزمون بررسی شدند.
    گروه کنترل: 40 کودک که از نظر جنس و سن به هم سازگار شده بودند به صورت تصادفی به یکی از گروههای آزمایش و کنترل تقسیم شدند که هر کدام شامل بیست نفر بودند. بیمارستان محک برخی خدمات رفاهی و اجتماعی را ارائه میداد. خدمات رفاهی و همچنین خدمات مددکاری اجتماعی برای گروه آزمایش و کنترل برابر بودند. کارکنان مددکاری اجتماعی کودک و خانواده او را برای آشنایی با سرطان ، خدمات موجود ، اقدامات بیمارستان و پرسنل و معالجات همراهی میکردند. علاوه بر این ، آنها یک اتاق بازی مشترک را که همه کودکان برای استفاده از آن آزاد بودند، فراهم کردند. آنها می توانستند از اسباب بازی های مختلف در آنجا استفاده کرده و با دیگران دوست شوند. والدین می توانستند فرزندان خود را در آنجا همراهی کنند و این تسهیلات توسط مددکاران اجتماعی هدایت می شد. اتاق روزانه 2 ساعت از 2 بعد از ظهر تا 4 بعد از ظهر باز بود. بچه ها می توانستند از میان وعده های آنجا استفاده کنند و باقی ماندن در آنجا اجباری نبود.

  • Recruitment centers

    #1
    Name of recruitment center - English: Mahak Hospital and Rehabilitation Complex
    Name of recruitment center - Persian: بیمارستان فوق تخصصی سرطان کودکان محک
    Full name of responsible person - English: Shima Shirafkan
    Full name of responsible person - Persian: شیما شیرافکن
    Street address - English: MAHAK Highly specialized Pediatric Cancer Hospital & Research Center, MAHAK Blvd., Shahid Majdi Blvd., Artesh Freeway, Tehran - Iran
    Street address - Persian: تهران، انتهای اتوبان امام علی- ابتدای اتوبان ارتش، بلوار شهید مژدی (بلوار اوشان سابق) ، بلوار جنت، بلوار محک، بیمارستان فوق تخصصی سرطان کودکان محک،
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Mahak Hospital and Rehabilitation Complex
    Name of recruitment center - Persian: بیمارستان فوق تخصصی سرطان کودکان محک
    Full name of responsible person - English: Shima Shirafkan
    Full name of responsible person - Persian: شیما شیرافکن
    Street address - English: MAHAK Highly specialized Pediatric Cancer Hospital & Research Center, MAHAK Blvd., Shahid Majdi Blvd., Artesh Freeway, Tehran - Iran
    Street address - Persian: تهران، انتهای اتوبان امام علی- ابتدای اتوبان ارتش، بلوار شهید مژدی (بلوار اوشان سابق) ، بلوار جنت، بلوار محک، بیمارستان فوق تخصصی سرطان کودکان محک،
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1956993461
    Phone: +98 21 2248 0908
    Fax: +98 21 2248 5456
    Email: Info@mahak-charity.org
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Mojtaba Habibi (P.H.D)
    Full name of responsible person - Persian: دکتر مجتبی حبیبی
    Street address - English: Shahid Beheshti University, Evin, Tehran.
    Street address - Persian: تهران، اوین، دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Mojtaba Habibi (P.H.D)
    Full name of responsible person - Persian: دکتر مجتبی حبیبی
    Street address - English: Shahid Beheshti University, Evin, Tehran.
    Street address - Persian: تهران، اوین، دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 29901
    Fax: +98 21 2243 1919
    Email: pr.office@mail.sbu.ac.ir
    Web page address:
    Yes
    empty
    empty
    Private
    empty
    Domestic
    empty
    Persons
    Shahid Beheshti University
    The main researcher (samaneh abedini)
    دانشگاه شهید بهشتی
    محقق اصلی (سمانه عابدینی)

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Mojtaba Habibi
    Full name of responsible person - Persian: مجتبی حبیبی
    Position - English: P.H.D
    Position - Persian: دکتری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Beheshti University, Evin, Tehran.
    Street address - Persian: تهران، اوین، دانشگاه شهید بهشتی.
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 33 1274 4183
    Mobile: 00
    Fax:
    Email: babakhabibius@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Laurentian Universiry
    Name of organization / entity - Persian: Laurentian Universiry
    Full name of responsible person - English: samaneh abedini najafabadi
    Full name of responsible person - Persian: سمانه عابدینی
    Position - English: Ph.D
    Position - Persian: دکتری
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: 866, prete st
    Street address - Persian: آپارتمان هفتم، ساختمان 866، خیابان پرت، سادبری، اونتاریو
    City - English: sudbury
    City - Persian: سادبری
    Province: Ontario
    Province - English: Ontario
    Province - Persian: اونتاریو
    contact.provinces_available:
    Country: Canada
    Postal code: P3E 3Y1
    Phone: +1 647-763-2962
    Mobile: 0016477632962
    Fax:
    Email: sabedini_najafabadi@laurentian.ca
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Mojtaba Habibi
    Full name of responsible person - Persian: مجتبی حبیبی
    Position - English: P.H.D
    Position - Persian: دکتری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Beheshti University, Tehran, Evin
    Street address - Persian: تهران-اوین-دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 33 1274 4183
    Mobile: 00
    Fax:
    Email: babakhabibius@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti University
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Mojtaba Habibi
    Full name of responsible person - Persian: مجتبی حبیبی
    Position - English: P.H.D
    Position - Persian: دکتری
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Beheshti University, Tehran, Evin
    Street address - Persian: تهران-اوین-دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 29901
    Mobile: +98 912 238 7577
    Fax: +98 21 2243 1919
    Email: babakhabibius@yahoo.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti university
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Samaneh Abedini
    Full name of responsible person - Persian: سمانه عابدینی
    Position - English: P.H.D
    Position - Persian: دکتری
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Beheshti University, Evin, Tehran
    Street address - Persian: تهران، اوین، دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 33 1274 4183
    Mobile: 00
    Fax:
    Email: m.dehghani@sbu.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Shahid Beheshti university
    Name of organization / entity - Persian: دانشگاه شهید بهشتی
    Full name of responsible person - English: Samaneh Abedini Najafabadi
    Full name of responsible person - Persian: سمانه عابدینی نجف آبادی
    Position - English: master
    Position - Persian: ارشد
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shahid Beheshti University, Evin, Tehran
    Street address - Persian: تهران، اوین، دانشگاه شهید بهشتی
    City - English: Tehran
    City - Persian: نجف آباد
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1983969411
    Phone: +98 21 29901
    Mobile: 0098 033 530 5841
    Fax: +98 21 2243 1919
    Email: samaneh.abedini88@gmail.com
    Web page address:

  • Sharing plan

    undecided
    yes
    yes
    undecided
    yes
    na
    na
    empty
    we have not decided yet for sharing the data set.
    empty
    ما هنوز در مورد به اشتراک گذاشتن داده های خود تصمیمی نگرفته ایم.
    empty
    to respect to confidentiality, we do not aim to share our participants' names or pictures, but we can share their general demographic features as well as the results of their assessments through our publications or presentations at conferences.
    empty
    با احترام به اصل رازداری ، هدف ما به اشتراک گذاشتن نام یا تصاویر شرکت کنندگان نیست ، بلکه می توانیم مشخصات عمومی جمعیتی و همچنین نتایج ارزیابی های آنها را از طریق مقالات یا ارائه های خود در کنفرانس ها به اشتراک بگذاریم.
    empty
    The results of data analysis will be available for everyone in google scholar when we could publish them in one scientific journal. it seems that in February of 2021 the article derived from the results will be published.
    empty
    زمانی که ما بتوانیم نتایج تحقیق خود را در مجله های علمی چاپ کنیم، نتایج تحلیل داده ها برای همه افراد در وبسایت گوگل اسکولار در دسترس خواهد بود. احتمالا نتیجه این تحقیق در سه ماهه اول سال 1400 در دسترس خواهد بود. احتمالا در فوریه سال 2021 مقاله ناشی از این داده ها چاپ خواهد شد.
    empty
    The results of data analysis will be available for the public.
    empty
    نتایج تحلیل داده ها برای عموم در دسترس خواهد بود.
    empty
    Persons who want to use the results of data analysis have to cite us and our research as a reference.
    empty
    افرادی که می خواهند از نتایج تحلیل داده های ما استفاده کنند باید به اسم محققان و تحقیق اشاره کنند.
    empty
    The results of data analysis can be downloaded from google scholar. Individuals interested in reading the article derived from these data can contact the corresponding author to receive the full-text article. Other researchers can contact Samaneh Abedini through the following email to receive the main article: samaneh.abedini88@gmail.com
    empty
    نتایج تحلیل داده ها می تواند از طریق وبسایت گوگل اسکولار دانلود شوند. این مقاله برای عموم آزاد خواهد بود و متقاضیان نیز می توانند در تماس با نویسنده مسئول فایل کامل مقاله را دریافت کنند. افراد می توانند از طریق آدرس ایمیل زیر با نویسنده اصلی این تحقیق خانم سمانه عابدینی تماس بگیرند. samaneh.abedini88@gmail.com
    empty
    Academic persons who need the data can send an email to the researchers. If they contacted the corresponding author, they could receive the article within one week.
    empty
    افراد دانشگاهی که تمایل به داشتن داده ها دارند می توانند با محققان از طریق ایمیل تماس بگیرند. بعد از تماس با نویسنده مسئول آنها در عرض یک هفته مقاله را دریافت خواهند کرد.

Protocol summary

Study aim
The aim of this study is the enhancement of emotional regulation in children with cancer.
Design
Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45-minutes. Sessions were conducted 5 times weekly for 4 weeks.
Settings and conduct
The study was conducted at the Mahak Hospital and Rehabilitation Complex. located in Tehran, Iran.
Participants/Inclusion and exclusion criteria
Hospitalized patients were eligible to participate in the MBCT-C if they were 11 to 13 years of age Patients who were determined to be diagnosed with a terminal illness were excluded.
Intervention groups
The primary aim of MBCT-C is to improve effective self-regulation through the development of mindful attention and to decenter from thoughts and emotions. The main component of this therapy is awareness of the present moment, which helps them decide more wisely. Unlike cognitive therapy, no effort is made to restructure or change existing thoughts and emotions. Individuals in this program learn to be mindful in daily life. The control group was 20 children with cancer hospitalized and were not under any psychological and psychiatric therapy.
Main outcome variables
Change in internalizing and attention problems.

General information

Reason for update
Mindfulness-Based Cognitive Therapy has been focused on the reduction in internalizing and attention problems as well as enhancement in emotional regulation. So, we decided to assess the variables which had more support in the literature review. We selected internalizing and attention problems because more studies examined them. Moreover, we found out in hospitalized children who could stay in the hospital for one month, internalizing and attention problems are more evident than adjustment problems. Hence, we decided to change the independent variable from adjustment to attention and internalizing problems. Besides, parents in the initial interviews reported that their children's internalizing and attention problems are more frequent than the adjustment problems. It became another reason to change the "adjustment" variable to the internalizing and attention issues.
Acronym
IRCT registration information
IRCT registration number: IRCT2013120614338N1
Registration date: 2013-12-06, 1392/09/15
Registration timing: registered_while_recruiting

Last update: 2021-01-02, 1399/10/13
Update count: 1
Registration date
2013-12-06, 1392/09/15
Registrant information
Name
Samaneh Abedini
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 33 1274 4183
Email address
sama_abedini@yahoo.com
Recruitment status
Recruitment complete
Funding source
Funded by researcher
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2014-03-11, 1392/12/20
Actual recruitment start date
2013-08-31, 1392/06/09
Actual recruitment end date
2014-03-10, 1392/12/19
Trial completion date
2014-03-10, 1392/12/19
Scientific title
The effectiveness of Modified Mindfulness-based Cognitive Therapy for hospitalized Children Hospitalized with Cancer compared to control group in attention problems and internalizing problems.
Public title
The Effectiveness of an Adapted Mindfulness-based Cognitive Therapy for Children with Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients were eligible to participate in the Mindfulness-Based Cognitive Therapy for Children (MBCT-C) program in addition to receiving TAU if they were (a) 11 to 13 years of age; (b) had at least average fluency in Persian; (c) had received the first diagnosis of any type of cancer except brain cancers; (d) were undergoing radiation therapy and/or chemotherapy through the hospital’s oncology division; and (e) had not received any psychological interventions or psychiatric medications in the six months preceding the study. Diagnostic inclusion criteria were: (f) a diagnosis of Autism spectrum disorder (ASD) (Diagnostic and Statistical Manual of Mental Disorders (IV) (DSM-IV (American Psychiatric Association, 2000); and (g) at least two comorbid diagnoses in any of four diagnostic categories (anxiety, depression, psychosomatic, or attention deficit disorders). Diagnoses were ascertained using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Persian version (K-SADS-PL-P). Additionally, patients needed to be: (h) in the borderline or clinical range for internalizing problems (T-score ≥ 60) and attention problems (T-score ≥ 57) on at least two of four subscales of the Child Behavior Checklist (CBCL) or Youth Self-Report (YSR )(depression/anxiety, withdrawal/depression, somatic complaints, and attention problems) at the screening assessment.
Exclusion criteria:
Patients who were determined to (i) have a major cognitive dysfunction or developmental disability, or (j) was diagnosed with a terminal illness (defined as having a prognosis of fewer than six months) were excluded. Moreover, Brain cancers were excluded based on research suggesting that these may affect attention (Raghubar et al., 2017), a key outcome variable.
Age
From 11 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
We utilized simple randomization through the excel file of random numbers. The unit of randomization was individual.
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
Shahid Beheshti University
Street address
Shahid Beheshti University, Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2013-08-27, 1392/06/05
Ethics committee reference number
58/850/ص

Health conditions studied

1

Description of health condition studied
cancer
ICD-10 code
F06.30
ICD-10 code description
Mood disorder due to known physiological condition, unspecified

2

Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

3

Description of health condition studied
depression
ICD-10 code
F06.31
ICD-10 code description
Mood disorder due to known physiological condition with depressive features

4

Description of health condition studied
somatic complaints
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

5

Description of health condition studied
attention problems
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders

Primary outcomes

1

Description
internalizing and attention problems
Timepoint
Before and 4 weeks after the treatment as well as 2-month follow-up
Method of measurement
CBCL and YSR

Secondary outcomes

1

Description
more cooperation in medical treatments in participants
Timepoint
Before and after the treatment as well as at follow-up point
Method of measurement
Interviews

Intervention groups

1

Description
Forty children (ages 11 to 13) diagnosed with cancer were randomly assigned to either a modified MBCT-C group (n = 20) or treatment as usual (TAU) control group (n = 20). To meet the needs of hospitalized participants, the manualized MBCT-C protocol was adapted to consist of 20 sessions, each lasting 45 min. Sessions were conducted 5 times weekly for 4 weeks. Primary outcome measures were the Child Behavior Checklist, Parent Report and its companion instrument, and the Youth Self-Report (YSR). Data were collected at pre-intervention, post-intervention, and at 2 months following the intervention.
Category
Treatment - Other

2

Description
Forty youth were age and gender-matched, and then randomly assigned to either a modified MBCT-C group (n = 20) or treatment-as-usual (TAU) control group (n = 20). Mahak hospital provided some welfare services and social work services. Welfare services as well as social work services was equal for both experimental and control group. Social workers were assigned to accompany the child and help the family to become acquainted with the cancer, available services, hospital procedure and personnel, and disjunctive treatment. Moreover, they facilitated a shared playroom that every child welcomed to join. They could use from various toys there and made friend with others. Parents could accompany their children there. And the group was lead by social workers. The room was open 2 hours daily from 2 pm to 4 pm. Children could use from snacks there and remaining there was not mandatory.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahak Hospital and Rehabilitation Complex
Full name of responsible person
Shima Shirafkan
Street address
MAHAK Highly specialized Pediatric Cancer Hospital & Research Center, MAHAK Blvd., Shahid Majdi Blvd., Artesh Freeway, Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1956993461
Phone
+98 21 2248 0908
Fax
+98 21 2248 5456
Email
Info@mahak-charity.org
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mojtaba Habibi (P.H.D)
Street address
Shahid Beheshti University, Evin, Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
+98 21 2243 1919
Email
pr.office@mail.sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The main researcher (samaneh abedini)
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Laurentian Universiry
Full name of responsible person
samaneh abedini najafabadi
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
866, prete st
City
sudbury
Province
Ontario
Postal code
P3E 3Y1
Phone
+1 647-763-2962
Fax
Email
sabedini_najafabadi@laurentian.ca
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Mojtaba Habibi
Position
P.H.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University, Tehran, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
+98 21 2243 1919
Email
babakhabibius@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti university
Full name of responsible person
Samaneh Abedini Najafabadi
Position
master
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
+98 21 2243 1919
Email
samaneh.abedini88@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
to respect to confidentiality, we do not aim to share our participants' names or pictures, but we can share their general demographic features as well as the results of their assessments through our publications or presentations at conferences.
When the data will become available and for how long
The results of data analysis will be available for everyone in google scholar when we could publish them in one scientific journal. it seems that in February of 2021 the article derived from the results will be published.
To whom data/document is available
The results of data analysis will be available for the public.
Under which criteria data/document could be used
Persons who want to use the results of data analysis have to cite us and our research as a reference.
From where data/document is obtainable
The results of data analysis can be downloaded from google scholar. Individuals interested in reading the article derived from these data can contact the corresponding author to receive the full-text article. Other researchers can contact Samaneh Abedini through the following email to receive the main article: samaneh.abedini88@gmail.com
What processes are involved for a request to access data/document
Academic persons who need the data can send an email to the researchers. If they contacted the corresponding author, they could receive the article within one week.
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