Determining the Effect of Group Cognitive-Behavioral Therapy(CBT) on Sleep disorders in Postmenopausal Women
Design
This study is a randomized controlled trial in which randomization will be done using block randomization method
Settings and conduct
The study will be done on postmenopausal women with sleep disorders, who will be referred to the Menopausal Clinic at Ahvaz Imam Khomeini Hospital. The study will be a randomized controlled trial with two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Postmenopausal women that at least one year and up to five years passed from their menopause, with age of 40 to 60 years, and those who will be eligible to participate in the study according to the questionnaire of identifying sleep problems. No-inclusion criteria: Severe anxiety and depression; taking antipsychotics drugs.
Intervention groups
At first, participants will be evaluated for sleep disorders using the related questionnaires Then women with sleep disorders will randomly be assigned into two groups of intervention and control. Then 6 counseling sessions according to the cognitive-behavior treatment for insomnia will be held for postmenopausal women in intervention group. For the control group, participants will complete the sleep disorder questionnaires and they will receive the routine care from postmenopausal clinic at the Imam Khomeini Hospital in Ahvaz.
Main outcome variables
Sleep disorders
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039082N1
Registration date:2018-06-26, 1397/04/05
Registration timing:retrospective
Last update:2018-06-26, 1397/04/05
Update count:0
Registration date
2018-06-26, 1397/04/05
Registrant information
Name
Hadis Moradifarsani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 5205
Email address
moradifarsani.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Group Cognitive-Behavioral Therapy(CBT) on Sleep disorders in Postmenopausal Women
Public title
The Effect of Group Cognitive-Behavioral Therapy(CBT) on Sleep disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being at the age of 40- 60 years
Passing for at least one year and up to 5 years from menopause
Being married
Literacy at least at a high school education
Having sleep disorder, according to the Insomnia Severity Index and Pitsburg Sleep Quality questionnaire
Willingness to participate in this study and providing written consent
Exclusion criteria:
Presence of medical problems Interfering with sleep disorders
Work at night shift
recent participation in psychotherapy or cognitive-behavioral therapy for other problems.
Recent severe trauma during the last three months
Taking sleeping and antipsychotics medications
Having mental illnesses such as severe depression and severe anxiety, that may leading to sleep problems
Smoking (more than 10 cigarettes a day), drug and alcohol use
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
In order to do the intervention, the women will be divided into two groups of 23 participant as control and intervention groups using block randomization with a block size of four and allocation ratio of one. For allocation concealment of women in the intervention and control groups, 23 4-digit even numbers will be chosen from random numbers as codes for participants of control group and 23 4-digit odd numbers for participants of intervention group will be chosen from random numbers table and they will be written according to the order of blocks. Then, the number of intervention and control groups will put in the opac envelops and then the envelops will be closed and they will be given randomly to the eligible women in the study by the secretary of menopause clinic (the researcher and the participant will not informed about allocation until the last moment
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A randomized controlled trial with a control group, randomized, with a block allocation to the groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University Medical Science, Golestan Ave. Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.AJUMS.REC.1397.014
Health conditions studied
1
Description of health condition studied
sleep disorders in menopausal women
ICD-10 code
G47
ICD-10 code description
Sleep disorders
Primary outcomes
1
Description
Sleep disorders
Timepoint
Sleep disorders (at the beginning of the intervention), before the intervention, 3, 6, and 10 weeks after the intervention.
Intervention group:for this group 6 sessions of 90 minutes counseling of cognitive behavior therapy will be held weekly.The content of sessions will be as follow: First session: introduction and orientation with group members, concept of menopause and changes during menopause, concept of insomnia models, sleep restriction and controlling the stimulants.Second and third sessions: management of sleep health and therapeutic cognitive with the aim of modifying the dysfunctional beliefs about sleep and effects of insomnia on daily performance will be tought. Fourth and fifth sessions: cognitive-behavioral treatment principles will be reinforced, and the sleep program will be adjusted according to the information of daily sleep log report. Sixth session: it will be focused on prevention from relapse and skills to deal with failures.
Category
Treatment - Other
2
Description
Control group: For this group, participants will complete the sleep disorder questionnaires and they will receive the routine care at postmenopausal clinic of the Imam Khomeini Hospital in Ahvaz.