The efficacy of Transdiagnostic Cognitive Behavior Therapy on emotional, cognitive and behavioral constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
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Protocol summary
Determinationt the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep and emtion regualtion in people with emotional disorders comorbid with insomnia disorder
Determinationt the efficacy of Transdiagnostic Cognitive Behavior Therapy on emotional, behavioral and cognitive constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
Determinationt the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severityemotional, beliefs about sleepbehavioral and emtion regualtioncognitive constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
تعیین اثر بخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابی، باورهای مرتبط با خواب و تنظیم هیجان مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
تعیین اثر بخشی درمان شناختی رفتاری فراتشخیصی بر سازه های هیجانی،رفتاری و شناختی مرتبط با بی خوابی در مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
تعیین اثر بخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابیسازه های هیجانی، باورهایرفتاری و شناختی مرتبط با خواب و تنظیم هیجانبی خوابی در مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep and emtion regualtion in people with emotional disorders comorbid with insomnia disorder
the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep, emtion regualtion,sleep quality and bedtime procrastination in people with emotional disorders comorbid with insomnia disorder
the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep, emtion regualtion,sleep quality and emtion regualtionbedtime procrastination in people with emotional disorders comorbid with insomnia disorder
پیامد اولیه یا پیامدهای موردمطالعه: اثر بخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابی، باورهای مرتبط با خواب و تنظیم هیجان مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
پیامد اولیه یا پیامدهای موردمطالعه: اثر بخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابی، باورهای مرتبط با خواب، تنظیم هیجان،کیفیت خواب و اهمال کاری زمان خواب در مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
پیامد اولیه یا پیامدهای موردمطالعه: اثر بخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابی، باورهای مرتبط با خواب و، تنظیم هیجان،کیفیت خواب و اهمال کاری زمان خواب در مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
General information
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Some variables are not registered in the previous edition designs
Some variables are not registered in the previous edition designs
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ثبت نشدن برخی متغیر ها در ویرایش قبلی طرح
ثبت نشدن برخی متغیر ها در ویرایش قبلی طرح
The efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep and emtion regulation in people with emotional disorders comorbid with insomnia disorder
The efficacy of Transdiagnostic Cognitive Behavior Therapy on emotional, cognitive and behavioral constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
The efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severityemotional, beliefs about sleepcognitive and emtion regulationbehavioral constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
اثربخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابی، باورهای مرتبط با خواب و تنظیم هیجان مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی در جمعیت دانشجویی
اثربخشی درمان شناختی رفتاری فراتشخیصی بر سازه های هیجانی،رفتاری و شناختی مرتبط با خواب در مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی
اثربخشی درمان شناختی رفتاری فراتشخیصی بر شدّت بی خوابیسازه های هیجانی، باورهایرفتاری و شناختی مرتبط با خواب و تنظیم هیجاندر مبتلایان به اختلال های هیجانی همبود با اختلال بی خوابی در جمعیت دانشجویی
Primary outcomes
#1
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Sleep-related beliefs
Sleep-related beliefs
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باورهای مرتبط با خواب
باورهای مرتبط با خواب
empty
Before intervention, after intervention and 3-month follow-up
Before intervention, after intervention and 3-month follow-up
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قبل مداخله، بعد مداخله و پیگیری 3 ماهه
قبل مداخله، بعد مداخله و پیگیری 3 ماهه
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Sleep-related beliefs scale
Sleep-related beliefs scale
empty
مقیاس باورهای مربوط به خواب
مقیاس باورهای مربوط به خواب
#2
empty
Emotion Regulation
Emotion Regulation
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تنظیم هیجان
تنظیم هیجان
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Before intervention, after intervention and 3-month follow-up
Before intervention, after intervention and 3-month follow-up
empty
قبل مداخله، بعد مداخله و پیگیری 3 ماهه
قبل مداخله، بعد مداخله و پیگیری 3 ماهه
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Difficult Emotion Regulation Scale
Difficult Emotion Regulation Scale
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مقیاس مشکل در تنظیم هیجانی
مقیاس مشکل در تنظیم هیجانی
Secondary outcomes
#1
Sleep-related beliefs
Sleep Quality
Sleep-related beliefs Quality
باورهای مرتبط با خواب
کیفیت خواب
باورهای مرتبط باکیفیت خواب
Sleep-related beliefs scale
Pittsburgh Sleep Quality Index
Pittsburgh Sleep-related beliefs scale Quality Index
مقیاس باورهای مربوط به خواب
شاخص کیفیت خواب پیتزبورگ (psqi)
مقیاس باورهای مربوط بهشاخص کیفیت خواب پیتزبورگ (psqi)
Determinationt the efficacy of Transdiagnostic Cognitive Behavior Therapy on emotional, behavioral and cognitive constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
Design
First, a sample of 300 people is selected from the population and after the initial screening of students, they are selected based on the cut line of Beck Depression Anxiety and Anxiety Tests and then Anxiety Disorders Interview Schedule for DSM-IV–Lifetime Version (ADIS-IV-L) and diagnostic interview is performed. A sample of 32 eligible students will be selected and will be randomly divided into two groups of 16 intervention and control based on their homogenization.
Settings and conduct
Study at Shahid Dr. Beheshti Educational and Medical Center in Zanjan on students of Zanjan University of Medical Sciences, without a placebo. Researchers and participants will be unaware of how randomization occurs.
Participants/Inclusion and exclusion criteria
Entry conditions:having a cut-off on Beck Depression and Anxiety Tests, Diagnosis of one of the emotional disorders based on the Anxiety Disorders Interview Schedule for DSM-IV–Lifetime Version (ADIS-IV-L), Morin's sleep scale cut-off. No entry conditions: ,Dont participate in one of the three evaluation stagesوHistory of psychological interventions, especially cognitive-behavioral therapy, in more than five psychotherapy sessions
Intervention groups
In this study, Barlow unified protocol will be used to perform the intervention. - It will take 6 months. 18 sessions of approximately one hour. The control group will not receive any treatment.
Main outcome variables
the efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia severity, beliefs about sleep, emtion regualtion,sleep quality and bedtime procrastination in people with emotional disorders comorbid with insomnia disorder
General information
Reason for update
Some variables are not registered in the previous edition designs
Acronym
IRCT registration information
IRCT registration number:IRCT20200112046097N1
Registration date:2020-07-26, 1399/05/05
Registration timing:registered_while_recruiting
Last update:2021-08-28, 1400/06/06
Update count:1
Registration date
2020-07-26, 1399/05/05
Registrant information
Name
Mahdiyeh Mohammadi jam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5537 6333
Email address
m.mohamadi.g@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-10, 1399/04/20
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Transdiagnostic Cognitive Behavior Therapy on emotional, cognitive and behavioral constructs sleep-related in people with emotional disorders comorbid with insomnia disorder
Public title
The efficacy of Transdiagnostic Cognitive Behavior Therapy on insomnia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Living in the city of Zanjan while doing research
The desire to participate in research
Having a cut-off line score on Beck Depression and Anxiety Inventory
Diagnosis of one of the emotional disorders based on the Anxiety Disorders Interview Schedule for DSM-IV–Lifetime Version (ADIS-IV-L)
Morin's sleep scale cut-off line score
Full consent of the candidate to participate in the project
Exclusion criteria:
Absence of more than two consecutive sessions in the integrated protocol
Dont participate in one of the three evaluation stages
History of psychological interventions, especially cognitive-behavioral therapy, in more than five psychotherapy sessions
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
In the first stage, participants will be asked about Beck Depression and Anxiety Inventory and the Maureen Insomnia Scale. . In the next step, with random number generator software in Excel, we assign qualified people to two intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and researchers were unaware of assignment to intervention and control groups, data evaluators were unaware of the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethice committee of Zanjan University of Medical Sciences
Street address
Azadi Boulevard, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
45136-15788
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.ZUMS.REC.1399.110
Health conditions studied
1
Description of health condition studied
insomnia
ICD-10 code
G47.0
ICD-10 code description
Insomnia
2
Description of health condition studied
Depressive episode
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
3
Description of health condition studied
Social phobias
ICD-10 code
F40.1
ICD-10 code description
Social phobias
4
Description of health condition studied
Panic disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia
5
Description of health condition studied
Phobic anxiety disorder
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders
6
Description of health condition studied
Agoraphobia
ICD-10 code
F40.0
ICD-10 code description
Agoraphobia
7
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
8
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Insomnia Severity
Timepoint
Before intervention, after intervention and 3-month follow-up
Method of measurement
Insomnia Severity Index
2
Description
Sleep-related beliefs
Timepoint
Before intervention, after intervention and 3-month follow-up
Method of measurement
Sleep-related beliefs scale
3
Description
Emotion Regulation
Timepoint
Before intervention, after intervention and 3-month follow-up
Method of measurement
Difficult Emotion Regulation Scale
Secondary outcomes
1
Description
Sleep Quality
Timepoint
Before intervention, after intervention and 3-month follow-up
Method of measurement
Pittsburgh Sleep Quality Index
2
Description
bedtime procrastination
Timepoint
Before intervention, after intervention and 3-month follow-up
Method of measurement
bedtime procrastination scale
Intervention groups
1
Description
intervention group: treatment, Barlow Unified protocol - 18 sessions of 60 minutes on the intervention group
Category
Behavior
2
Description
Control group: The control group was without action and no therapeutic intervention was performed
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Omid Saed (PhD)
Street address
Azadi Boulevard, Zanjan University of Medical Sciences
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 5244 0015
Fax
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
Azadi Boulevard, Zanjan University of Medical Sciences
City
zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3353 3400
Email
info@zums.ac.ir
Web page address
http://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
Omid Saed
Position
P.H.D
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ark Square - Shahid Dr. Beheshti Medical Center
City
zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 5244 0015
Fax
Email
o.saed@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahdieh Mohammadi Jam
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Saadi Crossroads, Ark Gate, Shahid Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1194753415
Phone
+98 21 5537 6333
Email
m.mohamadi.g@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahdieh Mohammadi Jam
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Saadi Crossroads, Ark Gate, Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 242433424766
Email
m.mohamadi.g@zums.ac.ir
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