Evaluating effects of cognitive behavioral therapy on illness perception in chronic insomnia disorder
Design
Randomized clinical trial with control group (waiting list). Both intervention group and control group include 1 participant. Randomization will carry out by someone who will blinded about study goals
Settings and conduct
After ending of recruitment of patients from a health centers and taking initial evaluation and checking out inclusive and exclusive criteria, patients will allocated randomly to two intervention and control group. During receiving and after end of treatments, all patients will assess five times by evaluator. Randomizer will unaware of the study goal. Researchers and therapists will have no role in evaluation of study outcomes. Also, evaluator will unaware of who belong to which group and the study goal.
Participants/Inclusion and exclusion criteria
Inclusive criteria: Age between 18 to 55 years old; Suffering from insomnia for three months or more; Education equal to or more than 12 grade in Iran; Completing informed consent form.
Exclusive criteria: Suffering from an unstable or undiagnosed disorder or disease; Comorbidity with schizophrenia, epilepsy, traumatic brain injury (TBI), bipolar disorder, and other sleep disorders; Taking a medication for treating insomnia disorder; Suffering from a cognitive impairment that makes it impossible to follow treatment instructions; Consuming drugs and alcohol until equal to or less than six months before the study begins; Having night or unstable work shift.
Intervention groups
Cognitive behavioral therapy include stimulus control therapy, sleep restriction therapy, sleep hygiene education, and cognitive therapy
Main outcome variables
Illness perception; sleep efficiency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043300N2
Registration date:2019-06-12, 1398/03/22
Registration timing:retrospective
Last update:2019-06-12, 1398/03/22
Update count:0
Registration date
2019-06-12, 1398/03/22
Registrant information
Name
Behzad Salmani
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 31 5568 3234
Email address
std_b.salmani@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-09, 1397/11/20
Actual recruitment start date
2018-11-06, 1397/08/15
Actual recruitment end date
2019-02-09, 1397/11/20
Trial completion date
2019-03-01, 1397/12/10
Scientific title
Evaluating effects of cognitive behavioral therapy compare to waiting list on illness perception in people with insomnia
Public title
Effects of cognitive behavioral therapy on illness perception in chronic insomnia disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 55 years old
Suffering from insomnia for three months or more
Education equal to or more than 12 grade in Iran
Completing informed consent form
Exclusion criteria:
Suffering from an unstable or undiagnosed disorder or disease
Comorbidity with schizophrenia, epilepsy, traumatic brain injury (TBI), bipolar disorder, and other sleep disorders
Taking a medication for treating insomnia disorder
Suffering from a cognitive impairment that makes it impossible to follow treatment instructions
Consuming drugs and alcohol until equal to or less than six months before the study begins
Having night or unstable work shift
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
2
Actual sample size reached:
2
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used. In order to randomization, researchers were used sealed pocket. Someone who was not in charge of applying interventions and evaluating of outcomes and was unaware of the study goals, run randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Control group: waiting list
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Kharazmi University
Street address
Somayyeh building, Kharazmi University, South Moffateh st, Tehran
Intervention group: Cognitive behavioral therapy: Eight weekly sessions; include stimulus control therapy, sleep restriction therapy, sleep hygiene education, and cognitive therapy. Duration of each session: 30 to 90 minutes.
Category
Behavior
2
Description
Control group: Waiting list
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Health Center
Full name of responsible person
Mehdi Khoobi
Street address
Standard st, Danesh boulevard
City
Kashan
Province
Isfehan
Postal code
8739114384
Phone
+98 31 5568 3234
Email
std_b.salmani@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research & technology assistance of Kharazmi University
Full name of responsible person
Dr. Jaafar Jahan Panah
Street address
Research & technology assistance, Somayyeh building, Kharazmi University, South mofatteh st
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8884 8944
Email
jahanpanah@khu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research & technology assistance of Kharazmi University
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
Kharazmi University
Full name of responsible person
Dr. Behzad Salmani
Position
Ph.D. in Health Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Maarefat 5 alley, enghelab town, Meshkat
City
Kashan
Province
Isfehan
Postal code
87391-14384
Phone
+98 31 5568 3234
Email
std_b.salmani@khu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Behzad Salmani
Position
دکترای تخصصی در روانشناسی سلامت
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Maarefat 5 alley, enghelab town, Meshkat
City
Kashan
Province
Isfehan
Postal code
87391-14384
Phone
+98 31 5568 3234
Email
b.salmani1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr. Jaafar Hasani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Somayyeh building, Kharazmi University, South mofatteh
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 8884 8944
Email
hasanimehr57@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Privacy in personal information
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available