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The effectiveness of cognitive behavioral group intervention on insomnia, bedtime procrastination and negative affect in student.

Protocol summary

Summary
Brief implementation method: The research method of this study is a clinical trial. First, according to the statistical population of this study, which will include all students of Zanjan University of Medical Sciences, a sample of 160 people will be available, then a questionnaire for insomnia (ISI) and symptoms of mental disorders, 25 questions (SCL-25) They will be implemented. Of those who scored ISI scores above 15 and SCL-25 scores below 45, and who have been suffering from insomnia for at least one month, a sample of 32 subjects was selected in a simple random manner and divided into two groups of 16 and control will be made. In the next step and in the pretest, a negligible questionnaire for BTPS, PANAS's positive and negative affective questionnaire will be implemented. In order to implement cognitive-behavioral insomnia for insomnia, the experimental group will use the protocol of Edinger and Carney (2008) as a group therapy, in the form of a 8-week 90-minute intervention, put a sleep hygiene leaflet to the control group to influence the cognitive domain. To be after performing group therapy intervention, the questionnaires are re-implemented and eventually follow-up one month after the intervention by re-running the questionnaires.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061834608N2
Registration date: 2017-10-10, 1396/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-10-10, 1396/07/18
Registrant information
Name
Zolfaghar Hosnavydehshams
Name of organization / entity
university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 914 871 1337
Email address
z.hosnavy@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive behavioral group intervention on insomnia, bedtime procrastination and negative affect in student.
Public title
The effectiveness of cognitive behavioral group intervention on insomnia, bedtime procrastination and negative affect.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion major conditions: sleep quality score higher than 15; less than 45 in test score of SCL-25; volunteered to participate in the plan satisfied Exclusion major conditions: sleep quality score below 15; score higher than 45 on tests of mental disorder symptoms SCL-25.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences Ethics Committee
Street address
Zanjan University Of Medical Sience, Azadi Blvd, Zanjan
City
Zanjan
Postal code
4515613191
Approval date
2017-05-27, 1396/03/06
Ethics committee reference number
ZUMS.REC.1396.35

Health conditions studied

1

Description of health condition studied
INSOMNIA
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep

Primary outcomes

1

Description
Insomnia
Timepoint
Pre test, Post test and one month Follow up
Method of measurement
Insomnia severity index

Secondary outcomes

1

Description
Negative affect
Timepoint
Pre test, Post test and one month Follow up
Method of measurement
Positive and Negative Affect Scale

2

Description
Bedtime procrastination
Timepoint
Pretest, Posttest and one month Follow up
Method of measurement
Bedtime Procrastination Scale

Intervention groups

1

Description
The implementation of the cognitive-behavioral group therapy for insomnia using the Edinger-Carney protocol in 8 sessions of 90 minutes on the experimental group includes the following sessions: 1. First and second sessions: Measures and therapeutic preparations (psycho-education) a. assessing the nature of sleeplessness and the suitability of the patient for cognitive-behavioral therapy, b. Review sleep baseline report. 2. Third and fourth sessions: Performing behavioral therapy component. a. Describe the logic of treatment and sleep training plan, b. Working on sleep rules, c. Calculating the initial time prescribed for bedding, d. assign homework. 3. Fifth and sixth sessions: using cognitive therapy strategies. a. review and comment on the results of a sleep report, b. explaining cognitive logic to the patient, c. discussing constructive worries. C. discussing the method of the memo of thoughts, d. assign homework. 4. Seventh and eighth sessions: principles of relapse prevention and problem-solving techniques. a. recommendations for adjusting the time spent in bed, b. reviewing and reinforcing compliance with treatment, c. resolving the difficulty of behavioral components, d. resolving the difficulty of cognitive components, e. terminating the treatment
Category
Other

2

Description
There is no treatment for the control group at the same time as working on the experimental group. But at the end of the work on experimental group, the same treatment will be performed on the control group.
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
Zanjan University of Medical Sciences, Azadi Blvd, Zanjan
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi Blvd, Zanjan.
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zolfaghar Hosnavy Dehshams
Position
M.Sc.candidate in clinical psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad, Zanjan.
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
zolfaghar.hosnavy@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zolfaghar Hosnavy Dehshams
Position
M.Sc. condidate in clinical psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad, Zanjan.
City
Zanjan
Postal code
Phone
+98 24 3353 4500
Fax
Email
Zolfaghar.hosnavy@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Zolfaghar Hosnavy Deshams
Position
MS candidate in clinical psychology
Other areas of specialty/work
Street address
Beheshti Hospital, Gate the Ark, Sadi Crossroad.
City
Zanjan
Postal code
Phone
+98 44 5846 1948
Fax
Email
Zolfaghar.hosnavy@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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