Protocol summary
-
Study aim
-
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
-
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
1
-
Sponsor
-
-
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
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
-
I have not made a decision yet
-
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