(1) Objectives: This study aimed to assess the efficacy of cognitive-behavioral therapy for insomnia on different aspects of sleep and quality of life in elderly women . (2) Design: This study is a Quasi-Experimental Research Method, containing pretest and post test design and a control group. The statistical population was all elderly women in Mashhad city that 20 people of them were selected voluntarily by Insomnia Severity Index and randomly divided into two 10 control and experimental groups .(3) Setting and conduct: at the baseline Both groups completed Insomnia Severity Index, Pittsburgh sleep quality and lei pad quality of life questionnaires and then The experimental group received treatment for 4 weeks with 2 sessions per week in 60 minutes but control group did not receive any treatment. After intervention, both groups completed the questionnaires again. (4) Participants including major eligibility criteria: The sample of this study includes and elderly women with primary insomnia disorder older than 60 years old, having the entry and exit conditions. (5) Intervention: Experimental group went under cognitive behavioral therapy for insomnia based on the Morin instruction including sleep hygiene, sleep restriction, modifying beliefs and cognitive errors.(6)Main outcome measures: Quality of life, Quality of sleep and Insomnia severity.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015091223955N2
Registration date:2017-05-04, 1396/02/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Mohammad Javad Asghari Ebrahimabad
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 5869
Email address
mjasghari@um.ac.ir
Recruitment status
Recruitment complete
Funding source
By researcher
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-07-23, 1393/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive-Behavioral Therapy for Insomnia on Severity and Quality of Sleep and Quality of Life in Elderly women
Public title
Effectiveness of Cognitive-Behavioral Therapy for Insomnia on Severity and Quality of Sleep and Quality of Life in Elderly women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The score higher than 7 in Insomnia Severity؛ The age over than 60 years old؛ Ability to write؛ Absence of Dementia and other Cognitive and major psychiatric deficits؛ Ability to understand and analyze؛ Desire to participate in the intervention.
Exclusion criteria: Secondary insomnia disorder؛ Medical problems and general medicine that leads to insomnia؛ Senior’s disinterest about the program؛ The participant’s death.
Age
From 60 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Ethics Committee of Ferdowsi University of Mashhad
Street address
Faculty of pschology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad
City
Mashhad
Postal code
Approval date
2014-06-11, 1393/03/21
Ethics committee reference number
567
Health conditions studied
1
Description of health condition studied
Nonorganic Insomnia
ICD-10 code
F51.0
ICD-10 code description
A condition of unsatisfactory quantity and/or quality of sleep
Primary outcomes
1
Description
Quality of Life
Timepoint
Before intervention - After intervention
Method of measurement
LEIPAD elderly quality of life questionaire
2
Description
Quality of sleep
Timepoint
Before intervention - After intervention
Method of measurement
The Pittsburgh Sleep Quality Index
3
Description
Insomna severity
Timepoint
Pre test - Post test
Method of measurement
Insomna Severity Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cognitive behavior intervention comes in group sessions based on Morin instruction twice a week 60 minutes per sessions for 4 weeks. This approach comes with instruction for sleep restriction, sleep hygiene, muscle relaxation, problem solving methods, training obstruction thought, mental imagery, opposite planning, clearing thoughts and skills to summarize distressing thoughts in a particular hours of a day.
Category
Behavior
2
Description
Control group: Control group had received no intervention at all they were analyzed for the sleep quality and quality of life before the intervention and after that using Insomnia severity index, Pittsburgh Sleep Quality and Leipad Quality of Life questionnaires.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculity of Education and Psychologys Clinic
Full name of responsible person
Dr.Seeyed Mohsen Asgari Nekah
Street address
Faculity of Education and Psychologys clinic, Ferdowsi University of Mashhad, Mashhad
City
Mashhsd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Ferdowsi University of Mashhad
Full name of responsible person
Bahrami Ahmad
Street address
Vice president for research, Ferdowsi University of Mashhad , Azadi, Sq, Mashhad, Iran, Mashhad
City
Mashhad
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 Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Malihe Hajary
Position
Master in Clinical Psychology
Other areas of specialty/work
Street address
faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3225 4084
Fax
Email
hajary_m@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Mohammad Javad Asghari Ebrahimabad
Position
PH.D Assistant Professor at Department of Clinical Psychology- Faculty of Education and Psychology
Other areas of specialty/work
Street address
Faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Ira
City
Mashhad
Postal code
Phone
+98 51 3880 5869
Fax
Email
mjasghari@um.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Malihe Hajary
Position
Master in Clinical Psychology
Other areas of specialty/work
Street address
Faculty of Education and Psychology, Fersowsi University of Mashhad,Azadi Sq, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 3225 4084
Fax
Email
hajary_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)