Comparisons of healthy sleep education alone and combined with pharmacotherapy in the treatment of sleep disturbances in Non-psychotic depressed patients
1) Objectives:
Main aim: Efficacy of healthy sleep education and pharmacotherapy alone or in combination for the treatment of sleep disorders in Non-psychotic depressed patients.
Goals: A- Determine of the effect of healthy sleep education in the treatment of sleep disorders in Non-psychotic depressed patients. B- Determine of the effect of Lorazepam in the treatment of sleep disorders in Non-psychotic depressed patients. C- Determine of the effect of healthy sleep education with Lorazepam in the treatment of sleep disorders in Non-psychotic depressed patients.
(2) Design: The study is a randomized clinical trial.
(3) Setting and conduct: Research environment is Farshchian psychiatry hospital in Hamedan city. 90 Non-psychotic depressive disorder patients will be in three therapeutic groups with random method. A- Healthy sleep education B- Pharmacotherpay C- Combination method. Non-psychotic depressive disorder will diagnose using DSM-IV criteria. Patients will assess with the Hamilton Depression Inventory and sleep disorders questionnaire before and after treatment.
(4) Participants including major eligibility criteria: Participants included Non-psychotic depressive disorder patients with inclusion middle age group (35-60)؛ No history of psychiatric disorders associated؛ No history of serious physical illness؛ Treated with SSRI antidepressants؛ The ability to read and write. Exclusion criteria included Electroconvulsive therapy؛ Having physical pain from chronic diseases؛ History of substance abuse.
(5) Intervention: Group 1: Patients in group 1 will receive Lorazepam 1mg per night for 4 week.
Group 2: Patients in group 2 will receive sleep hygiene education face to face training and pamphlets.
Group 3: Patients in group 3 will receive sleep healthy education face to face training and pamphlets and Lorazepam 1mg per night for 4 week.
(6) main outcome measures (variables): status of sleep disorders and depressive level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012100411004N1
Registration date:2013-07-09, 1392/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
Registrant information
Name
Farshid Shamsaei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
shamsaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical SciencesAdd: Hamadan University of Medical Sciences, Shahid Fahmideh Bulv, Hamedan, Postal cod: 65178
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparisons of healthy sleep education alone and combined with pharmacotherapy in the treatment of sleep disturbances in Non-psychotic depressed patients
Public title
Treatment of sleep disorders in patients with non-psychotic depressed
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Middle age group (35-60؛ No history of psychiatric disorders associated؛ No history of serious physical illness؛ Treated with SSRI antidepressants؛ The ability to read and write. Exclusion criteria included Electroconvulsive therapy؛ Having physical pain from chronic diseases؛ History of substance abuse.
Age
From 35 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Hamadan university of medical sciences
Street address
Vice chancellor for research, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv.
City
Hamedan
Postal code
65178
Approval date
2013-05-20, 1392/02/30
Ethics committee reference number
709/9/35/16/P/D
Health conditions studied
1
Description of health condition studied
Depressive disorder
ICD-10 code
F30, F31,
ICD-10 code description
Mood [affective] disorders
Primary outcomes
1
Description
Sleep disorders
Timepoint
Before and 4 week after
Method of measurement
Sleep Disorders Inventory
Secondary outcomes
1
Description
Depressive level
Timepoint
Before and four weeks after
Method of measurement
Hamilton Depression Scale
Intervention groups
1
Description
Group 1: patients in group 1 will receive Lorazepam 1mg per night for 4 week.
Category
Treatment - Drugs
2
Description
Group 2: patients in group 2 will receive sleep healthy education face to face training and pamphlets.
Category
Other
3
Description
Group 3: patients in group 3 will receive sleep healthy education face to face training and pamphlets and Lorazepam 1mg per night for 4 week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian psychiatry hospital
Full name of responsible person
Farshid Shamsaei
Street address
Farshchian psychiatry hospital, Research center for behavioral disorders and substance abuse, Dibaj Ave
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan university of medical sciences
Full name of responsible person
Hidar Tavilani
Street address
Vice chancellor for research, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv, Hamedan
City
Hamedan
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, Hamadan 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
Hamadan university of medical sciences
Full name of responsible person
Farshid Shamsaei
Position
Assistan Professor
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, Hamadan University of Medical Sciences, Shahid Fahmideh Bulv, Hamedan
City
Hamedan
Postal code
65178
Phone
+98 81 1823 2193
Fax
Email
shamsaei68@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of medical sciences
Full name of responsible person
Farshid Shamsaei
Position
Assistant Prof.
Other areas of specialty/work
Street address
Farshchian psychiatry hospital, Research center for behavioral disorders and substance abuse, Dibaj Ave.
City
Hamedan
Postal code
Phone
+98 81 1827 1066
Fax
+98 81 1827 1066
Email
shamsaei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Research Center for Behavioral Disorders and Substance Abuse, Hamadan University of Medical Sciences
Full name of responsible person
Farshid Shamsaei
Position
Assistan Prof.
Other areas of specialty/work
Street address
Farshchian Psychiatry Hospital, Research Center for Behavioral Disorders and Substance Abuse, Dibaj Ave.
City
Hamedan
Postal code
Phone
+98 81 1827 1066
Fax
+98 81 1827 1066
Email
shamsaei@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)