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The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial

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History
# Registration date Revision Id
2 2023-11-14, 1402/08/23 289032
1 2019-03-04, 1397/12/13 81779
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  • Protocol summary

    تعیین اثربخشی درمان گروهی فعال‌سازی رفتاری بر شدّت افسردگی، افکارتکرارشونده و عملکرد دانشجویان
    تعیین اثربخشی درمان گروهی فعال‌سازی رفتاری بر شدّت افسردگی، افکار تکرار شونده و عملکرد دانشجویان
    This double blind randomized clinical trial has an intervention and a control group.
    This double-blind controlled clinical trial has an intervention group and a control group. The participants were screened in two stages, first, they were evaluated using BDI-II, those who scored 14 and highest were invited to interview (n=96). Then participants based on inputs and outputs and diagnosis of Major Depressive Disorder (n=40) were assigned to two groups with the Random number generator V 1.3 (n=20). Finally, the interventions were done and after the interventions and assessments, the information was analyzed by SPSS (n=36).
    این کارآزماییِ بالینیِ شاهددارِ دوسوکور دارای یک گروه مداخله و یک گروه کنترل است.
    این کارآزماییِ بالینیِ شاهددارِ دوسوکور دارای یک گروه مداخله و یک گروه کنترل است. غربالگری شرکت کنندگان در دو مرحله انجام شد، ابتدا با استفاده از ویراست دوم از پرسشنامه افسردگی بک مورد ارزیابی قرار گرفتند، سپس کسانی که نمره 14 و بالاتر داشتند برای ارزیابی ثانویه دعوت شدند (96 نفر). در این مرحله، شرکت کنندگان با مصاحبه بالینی و ارزیابی معیارهای ورود و خروج ارزیابی شدند و کسانی که دارای ملاک‌های اختلال افسردگی اساسی بودند لیست شدند (40 نفر) و با نرم افزار Random number generator V 1.3 به دو گروه اختصاص داده شدند (هر گروه 20 نفر) و مداخلات روی آنها صورت گرفت. در نهایت بعد از انجام مداخلات و ارزیابی‌ها اطلاعات 36 نفر از شرکت کنندگان با استفاده از نرم افزار اس تحلیل شد.
    After a diagnostic interview by a psychiatrist, patients who are diagnosed with major depressive disorder are randomly assigned to intervention and control groups, also assessments will done in one, three, and six months after the intervention.
    After a diagnostic interview by a psychiatrist, patients who are diagnosed with major depressive disorder are randomly assigned to intervention and control groups, also assessment will done in two months after the intervention.
    بعد از مصاحبه تشخیصی توسط روان‌پزشک بیمارانی که تشخیص اختلال افسردگی اساسی می گیرند به صورت تصادفی به دو گروه مداخله و کنترل تخصیص داده می شوند، همچنین ارزیابی هایی با فاصلۀ یک، سه و شش ماه بعد از مداخله صورت می گیرد. محل انجام مصاحبه و مداخلات دپارتمان روانپزشکی و روانشناسی دانشگاه علوم پزشکی زنجان است.
    بعد از مصاحبه تشخیصی توسط روان‌پزشک بیمارانی که تشخیص اختلال افسردگی اساسی می‌گیرند به صورت تصادفی به دو گروه مداخله و کنترل تخصیص داده می‌شوند، همچنین ارزیابی‌ با فاصلۀ دو ماه بعد از مداخله صورت می‌گیرد. محل انجام مصاحبه و مداخلات دپارتمان روانپزشکی و روانشناسی دانشگاه علوم پزشکی زنجان است.
    Inclusion criteria: 1. Being university student 2. Residence in Zanjan while researching 3. Tending to participate in research 4. Scores between 15 - 25 in beck depression inventory second edition and major depressive disorder diagnosis by the psychiatrist. Exclusion criteria: 1. Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders 2. Depression related to medical condition 3. Previous psychological intervention specially cognitive behavioral therapy more than five sessions 4. Consume psychotropic drugs 5. The history of hospitalization and receiving electroconvulsive therapy (ECT)
    Inclusion criteria: 1. Being university student 2. Residence in Zanjan while researching 3. Tending to participate in research 4. Scores between 14 - 25 in beck depression inventory second edition and major depressive disorder diagnosis by the psychiatrist. Exclusion criteria: 1. Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders 2. Depression related to medical condition 3. Previous psychological intervention specially cognitive behavioral therapy more than five sessions 4. Consume psychotropic drugs 5. The history of hospitalization and receiving electroconvulsive therapy (ECT)
    معیار ورود: 1. دانشجو بودن 2. سکونت در شهر زنجان به هنگام انجام پژوهش 3. تمایل به شرکت در پژوهش 4. نمرۀ بین 15 تا 25 در ویرایش دوّم پرسشنامه افسردگی بک و تشخیص اختلال افسردگی توسط روان‌پزشک. معیار خروج: 1. سابقۀ سایکوز، اختلال های مرتبط با سوء مصرف مواد، اختلال دوقطبی و اختلال های شخصیت 2.افسردگی ناشی از بیماری های طبی 3. سابقۀ قبلی مداخله های روان‌شناختی به خصوص درمان شناختی-رفتاری بیشتر از 5 جلسه روان درمانی 4. مصرف داروهای روان‌پزشکی 5. سابقۀ بستری و دریافت الکتروشوک درمانی
    معیار ورود: 1. دانشجو بودن 2. سکونت در شهر زنجان به هنگام انجام پژوهش 3. تمایل به شرکت در پژوهش 4. نمرۀ بین 14 تا 25 در ویرایش دوّم پرسشنامه افسردگی بک و تشخیص اختلال افسردگی توسط روان‌پزشک. معیار خروج: 1. سابقۀ سایکوز، اختلال های مرتبط با سوء مصرف مواد، اختلال دوقطبی و اختلال های شخصیت 2.افسردگی ناشی از بیماری های طبی 3. سابقۀ قبلی مداخله های روان‌شناختی به خصوص درمان شناختی-رفتاری بیشتر از 5 جلسه روان درمانی 4. مصرف داروهای روان‌پزشکی 5. سابقۀ بستری و دریافت الکتروشوک درمانی

  • General information

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    During the research process, modifications were implemented based on existing limitations and opportunities. The key changes include: 1. As the number of patients with a diagnosis interval exceeded expectations and enlarging the sample size had no impact on the research process, a consultation with the scientific research team, including the supervisor, led to an increase in the sample size to 40 individuals. 2. Considering the university's limitation on academic years, the follow-up period was shortened from 6 months to 2 months in collaboration with the department director and supervisor.
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    در روند اجرای پژوهش با توجه به فرصت‌ها و محدودیت‌ها تغییراتی در روند اجرای پژوهش انجام داده شد، که مهترین آنها به شرح زیر است: 1. با توجه اینکه تعداد دانشجویانی مبتلا به افسردگی تشخیص‌گذاری شدند بیشتر از حد انتظار بود و افزایش حجم نمونه مداخله‌ای در روند اجرای پژوهش ایجاد نمی‌کرد، بنابراین با مشورت تیم علمی پژوهش شامل استاد راهنما و مشاور حجم نمونه به 40 نفر افزایش یافت. 2. مدت زمان پیگیری باتوجه به محدودیت سنوات تحصیلی در دانشگاه با هماهنگی مدیر گروه و استاد راهنما از 6 ماه به 2 ماه کاهش یافت.
    Being university student
    Residence in Zanjan while researching
    Tending to participate in research
    Scores between 15 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist
    Being university student
    Residence in Zanjan while researching
    Tending to participate in research
    Scores between 14 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist
    دانشجو بودن
    سکونت در زنجان به هنگام پژوهش
    تمایل به شرکت در پژوهش
    نمرۀ بین 15 تا 25 در نسخه دوّم پرسشنامه افسردگی بک و تشخیص اختلال افسردگی اساسی توسط روان‌پزشک
    دانشجو بودن
    سکونت در زنجان به هنگام پژوهش
    تمایل به شرکت در پژوهش
    نمرۀ بین 14 تا 25 در نسخه دوّم پرسشنامه افسردگی بک و تشخیص اختلال افسردگی اساسی توسط روان‌پزشک
    After diagnosis by the psychiatrist, using the random number generator V 1.3 patients will assign to two treatment and control groups; so that all participants have equal chance of being in the groups.
    After diagnosis by the psychiatrist, a list of patients with inclusion criteria is prepared and numbered and assigned to treatment and control groups by Random number generator V 1.3 software; so that all participants have equal chance of being in the groups.
    بعد از تشخیص گذاری توسط متخصص، بیماران توسط نرم افزار Random number generator V 1.3 به دو گروه درمان و کنترل اختصاص داده می شوند، به طوری که همه شرکت کنندگان شانس برابری برای حضور در گروه ها داشته باشند.
    بعد از تشخیص گذاری توسط متخصص، لیستی از بیماران دارای ملاک‌های ورود تهیه می شود و به صورت شماره گذاری شده و با استفاده از نرم افزار Random number generator V 1.3 به دو گروه درمان و کنترل اختصاص داده می شوند، به طوری که همه شرکت کنندگان شانس برابری برای حضور در گروه ها داشته باشند.

  • Primary outcomes

    #1
    Pre-test, Post-test and follow up (One, Three and six months after post-test)
    Pre-test, Post-test and follow up (Two months after post-test)
    پیش آزمون، پس آزمون و پیگیری (یک، سه و شش ماه بعد از مداخله)
    پیش آزمون، پس آزمون و پیگیری (دو ماه بعد از مداخله)

  • Secondary outcomes

    #1
    Pre-test, Post-test and Follow up (One, Three and Six months after post- test)
    Pre-test, Post-test and Follow up (Two months after post- test)
    پیش آزمون، پس آزمون و پیگیری (یک، سه و شش ماه بعد از پس آزمون)
    پیش آزمون، پس آزمون و پیگیری (دو ماه بعد از پس آزمون)
    #2
    Pre-test, Post-test and Follow up (One, Three and Six months after post- test)
    Pre-test, Post-test and Follow up (Two months after post- test)
    پیش آزمون، پس آزمون و پیگیری (یک، سه و شش ماه بعد از پس آزمون)
    پیش آزمون، پس آزمون و پیگیری (دو ماه بعد از پس آزمون)

  • Intervention groups

    #1
    Intervention group will receive fourteen session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.
    Intervention group will receive ten session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.
    گروه مداخله درمانِ فعّال‌سازی رفتاری گروهی را دریافت می کنند. چهارده جلسه است و به صورت گروهی انجام می شود. این مداخله براساس پروتکل سی دبلیو. لجوز و دِرِک آر. هوپکو است و شامل آموزش روانشناختی، پایش فعالیت، برنامه ریزی فعالیت و روشن سازی ارزشها است.
    گروه مداخله درمانِ فعّال‌سازی رفتاری گروهی را دریافت می کنند. ده جلسه است و به صورت گروهی انجام می شود. این مداخله براساس پروتکل سی دبلیو. لجوز و دِرِک آر. هوپکو است و شامل آموزش روانشناختی، پایش فعالیت، برنامه ریزی فعالیت و روشن سازی ارزشها است.

  • Recruitment centers

    #1
    Name of recruitment center - English: Zanjan University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Omid Saed
    Full name of responsible person - Persian: امید ساعد
    Street address - English: Zanjan University of Medical Sciences, Azadi Square
    Street address - Persian: میدان آزادی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 45156-13191
    Phone: +98 24 3342 0670
    Fax: +98 24 3354 2403
    Email: info@zums.ac.ir
    Web page address: http://zums.ac.ir/
    Name of recruitment center - English: Zanjan University of Medical Sciences
    Name of recruitment center - Persian: دانشگاه علوم پزشکی زنجان
    Full name of responsible person - English: Omid Saed
    Full name of responsible person - Persian: امید ساعد
    Street address - English: Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
    Street address - Persian: زنجان، بلوار دکتر یوسف ثبوتی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Country: Iran (Islamic Republic of)
    Postal code: 4513956184
    Phone: +98 24 3342 0670
    Fax: +98 24 3354 2403
    Email: info@zums.ac.ir
    Web page address: http://zums.ac.ir/

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Soleiman Saberi
    Full name of responsible person - Persian: سلیمان صابری
    Position - English: Masters Student
    Position - Persian: دانشجو کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
    Street address - Persian: میدان ارگ, خیابان بعثت، بیمارستان بهشتی، دپارتمان روانشناسی بالینی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 45136-15788
    Phone: +98 24 3354 2403
    Mobile: +98 939 646 7172
    Fax:
    Email: s.saberipsy@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Soleiman Saberi
    Full name of responsible person - Persian: سلیمان صابری
    Position - English: Psychologist at Student's counselling and Mental Health Office
    Position - Persian: روانشناس اداره مشاوره و سلامت روان دانشجویی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
    Street address - Persian: زنجان، بلوار دکتر یوسف ثبوتی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 4513956184
    Phone: +98 24 3344 5211
    Mobile: +98 939 646 7172
    Fax:
    Email: s.saberipsy@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Omid Saed
    Full name of responsible person - Persian: امید ساعد
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
    Street address - Persian: میدان ارگ، خیابان بعثت، بیمارستان بهشتی، دپارتمان روانشناسی بالینی
    City - English: zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۵۷۸۸-۴۵۱۳۶
    Phone: +98 24 3354 2403
    Mobile: +98 912 842 5270
    Fax:
    Email: o.saed@zums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Omid Saed
    Full name of responsible person - Persian: امید ساعد
    Position - English: Assistant Professor
    Position - Persian: استادیار
    Latest degree: phd
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
    Street address - Persian: میدان ارگ، خیابان بعثت، بیمارستان بهشتی، دپارتمان روانشناسی بالینی
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۵۷۸۸-۴۵۱۳۶
    Phone: +98 24 3354 2403
    Mobile: +98 912 842 5270
    Fax:
    Email: o.saed@zums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Soleiman Saberi
    Full name of responsible person - Persian: سلیمان صابری
    Position - English: Masters Student
    Position - Persian: دانشجو کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
    Street address - Persian: میدان ارگ، خیابان بعثت، بیمارستان بهشتی، دپارتمان روانشناسی بالینی
    City - English: zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۵۷۸۸-۴۵۱۳۶
    Phone: +98 24 3354 2403
    Mobile: +98 939 646 7172
    Fax:
    Email: s.saberipsy@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Soleiman Saberi
    Full name of responsible person - Persian: سلیمان صابری
    Position - English: Psychologist at Student's counselling and Mental Health Office
    Position - Persian: روانشناس اداره مشاوره و سلامت روان دانشجویی
    Latest degree: master
    Area of specialty/work: 48
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
    Street address - Persian: زنجان، بلوار دکتر یوسف ثبوتی، دانشگاه علوم پزشکی زنجان
    City - English: Zanjan
    City - Persian: زنجان
    Province: Zanjan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: ۱۵۷۸۸-۴۵۱۳۶
    Phone: +98 24 3344 5211
    Mobile: +98 939 646 7172
    Fax:
    Email: s.saberipsy@gmail.com
    Web page address:

  • Sharing plan

    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    undecided
    yes
    Start the access period from 2020
    Start the access period from 2023
    شروع دوره دسترسی از سال 1399
    شروع دوره دسترسی از سال 1402
    1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed 2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi, Mobile: +989396467172
    1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed 2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi
    1. بیمارستان شهید بهشتی زنجان، دپارتمان روانشناسی بالینی، دکتر امید ساعد 2. بیمارستان شهید بهشتی زنجان، دپارتمان روانشناسی بالینی، سلیمان صابری، موبایل: 09396467172
    1. بیمارستان شهید بهشتی زنجان، دپارتمان روانشناسی بالینی، دکتر امید ساعد 2. بیمارستان شهید بهشتی زنجان، دپارتمان روانشناسی بالینی، سلیمان صابری
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    Researchers can contact S.saberipsy@gmail.com to access the results and details.
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    محققان می‌توانند با مکاتبه با ایمیل S.saberipsy@gmail.com از نتایج و جزئیات پژوهش فوق بهره‌مند شوند.

Protocol summary

Study aim
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
Design
This double-blind controlled clinical trial has an intervention group and a control group. The participants were screened in two stages, first, they were evaluated using BDI-II, those who scored 14 and highest were invited to interview (n=96). Then participants based on inputs and outputs and diagnosis of Major Depressive Disorder (n=40) were assigned to two groups with the Random number generator V 1.3 (n=20). Finally, the interventions were done and after the interventions and assessments, the information was analyzed by SPSS (n=36).
Settings and conduct
After a diagnostic interview by a psychiatrist, patients who are diagnosed with major depressive disorder are randomly assigned to intervention and control groups, also assessment will done in two months after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Being university student 2. Residence in Zanjan while researching 3. Tending to participate in research 4. Scores between 14 - 25 in beck depression inventory second edition and major depressive disorder diagnosis by the psychiatrist. Exclusion criteria: 1. Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders 2. Depression related to medical condition 3. Previous psychological intervention specially cognitive behavioral therapy more than five sessions 4. Consume psychotropic drugs 5. The history of hospitalization and receiving electroconvulsive therapy (ECT)
Intervention groups
Intervention group will receive behavioral activation group therapy; and control group will receive only behavioral activation booklet.
Main outcome variables
Depression severity, repetitive thoughts and educational social function

General information

Reason for update
During the research process, modifications were implemented based on existing limitations and opportunities. The key changes include: 1. As the number of patients with a diagnosis interval exceeded expectations and enlarging the sample size had no impact on the research process, a consultation with the scientific research team, including the supervisor, led to an increase in the sample size to 40 individuals. 2. Considering the university's limitation on academic years, the follow-up period was shortened from 6 months to 2 months in collaboration with the department director and supervisor.
Acronym
IRCT registration information
IRCT registration number: IRCT20181128041782N1
Registration date: 2019-03-04, 1397/12/13
Registration timing: registered_while_recruiting

Last update: 2023-12-20, 1402/09/29
Update count: 1
Registration date
2019-03-04, 1397/12/13
Registrant information
Name
Soleiman Saberi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 910 472 0804
Email address
S.saberipsy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-07-14, 1398/04/23
Scientific title
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students with major depressive disorder: A double blind randomized clinical trial
Public title
The effectiveness of behavioral activation group therapy in severity of depression, repetitive thoughts and functions of students
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being university student Residence in Zanjan while researching Tending to participate in research Scores between 14 - 25 in beck depression inventory second edition and dajor depressive disorder diagnosis by the psychiatrist
Exclusion criteria:
Having a history of psychosis, substance abuse, bipolar mood disorder and personality disorders Depression related to medical condition Previous psychological intervention specially cognitive behavioral therapy more than five sessions Consume psychotropic drugs The history of hospitalization and receiving electroconvulsive therapy (ECT)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 32
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
After diagnosis by the psychiatrist, a list of patients with inclusion criteria is prepared and numbered and assigned to treatment and control groups by Random number generator V 1.3 software; so that all participants have equal chance of being in the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
After sampling, any of participant will not aware from randomization and allocation to groups. The data analyzer is selected outside of the study and all of datas will be given to him as a code.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Scienses
Street address
Zanjan University of Medical Sciences, Azadi Square
City
Zanjan
Province
Zanjan
Postal code
45156-13191
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.ZUMS.REC.1397.255

Health conditions studied

1

Description of health condition studied
Major Depressive Disorder - Mild
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild

2

Description of health condition studied
Major Depressive Disorder - Moderate
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate

Primary outcomes

1

Description
Depression Severity
Timepoint
Pre-test, Post-test and follow up (Two months after post-test)
Method of measurement
Beck Depression Inventory-II (BDI-II)

Secondary outcomes

1

Description
Repetitive thoughts
Timepoint
Pre-test, Post-test and Follow up (Two months after post- test)
Method of measurement
Repetitive Thinking Questionnaire-31

2

Description
Function of students
Timepoint
Pre-test, Post-test and Follow up (Two months after post- test)
Method of measurement
Work (Educational) and Social Adjustment Scale

Intervention groups

1

Description
Intervention group will receive ten session of Behavioral Activation Group Therapy. This intervention based on C. W. Lejuez and Derek R. Hopko's protocol and includes psycho-education, activity monitoring, activity planning and values clarification.
Category
Behavior

2

Description
Control group will receive only behavioral activation booklet، which contains the same topics with the intervention group and will be checked weekly by internet and and guidance will be provide if needed.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Street address
Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0670
Fax
+98 24 3354 2403
Email
info@zums.ac.ir
Web page address
http://zums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Blvd
City
zanjan
Province
Zanjan
Postal code
45136-15788
Phone
+98 24 3342 0651
Email
info@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
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
Zanjan University of Medical Sciences
Full name of responsible person
Soleiman Saberi
Position
Psychologist at Student's counselling and Mental Health Office
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3344 5211
Email
s.saberipsy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Omid Saed
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Department of Clinical Psychology, Beheshti Hospital, Besat Ave, Arg Square
City
Zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3354 2403
Email
o.saed@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Soleiman Saberi
Position
Psychologist at Student's counselling and Mental Health Office
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Zanjan University of Medical Sciences, Dr.Sobouti Blvd., Zanjan, Iran
City
Zanjan
Province
Zanjan
Postal code
۱۵۷۸۸-۴۵۱۳۶
Phone
+98 24 3344 5211
Email
s.saberipsy@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the information related to main outcome will be published.
When the data will become available and for how long
Start the access period from 2023
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Access to documents is possible to inform other researchers. Access to documents is possible to work with the researcher.
From where data/document is obtainable
1. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Dr Omid Saed 2. Dr. Beheshti Hospital, Zanjan, Department of Clinical Psychology, Soleiman Saberi
What processes are involved for a request to access data/document
Documents will be shared only when the reason for the request is announced by phone or e-mail.
Comments
Researchers can contact S.saberipsy@gmail.com to access the results and details.
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