This study is a double blind randomized clinical trial. The participants are substance dependent patients aged 18-60 years that are managed with methadone maintenance therapy in Shafa Hospital. These patients have insomnia that is confirmed by Pittsburgh Sleep quality index (PSQI) and psychiatric interview (on DSM-IV-TR criteria). After considering inclusion criteria, 30 patients are enrolled. After informing written consent, the patients are allocated randomly to treatment or control groups. At first, a demographic questionnaire is filled and a urinary screening test for substance (opium, methamphetamine, benzodiazepine) is performed. In treatment group, the patients participate in weekly cognitive behavioural therapy sessions for 8 weeks. A clinical psychologist manages this 45 minutes sessions. In control group, the patients participate in weekly placebo behavioural therapy sessions for 8 weeks. A psychitric resident manages this 45 minutes sessions. The urinary screening test for substance is performed weekly. In the end of 4th and 8th weeks, another psychiatric resident fills PSQI questionnaire.
General information
Acronym
Cognitive behavioral therapy - CBT
IRCT registration information
IRCT registration number:IRCT201206011483N3
Registration date:2012-06-09, 1391/03/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-09, 1391/03/20
Registrant information
Name
Mir Mohammad Jalali
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 3085
Email address
mmjalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice-chancellorship for research, Guilan university of medical sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
cognitive – behavior therapy effect on insomnia in patients undergoing methadone maintenance treatment at Shafa hospital , Rasht
Public title
psychotherapy effect on insomnia in patients undergoing methadone maintenance treatment at Shafa hospital , Rasht
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age between 18-60
2- Academic level above high school
3- Pittsburgh Sleep Quality Index >= 5 and confirmation of this diagnosis in psychiatric interview (on DSM-IV-TR criteria).
4- No comorbid psychiatric disorders (Bipolar I or II disorder, Scihzophrenia, Major depression disorder in last month, Anxiety disorder)
5- No related chronic medical disease with insomnia
6- Known stabilization dosage of methadone maintenance therapy
7- No sedative drugs usage in last week
Exclusion criteria:
1- No continuous presence in weekly treatment sessions
2- No comorbid substance abuse or usage of sedative drugs in period of methadone maintenance therapy ( except nicotine usage)
3- Discontinuation of methadone maintenance therapy
4- Substance withdrawal symptoms
Age
From 18 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
vice-chancellorship for research, Guilan university of medical sciences
Street address
Siadetii street, Namjoo street
City
Rasht
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
1910095607
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 [insomnias]
Primary outcomes
1
Description
PSQI score
Timepoint
before intervention, the end of fourth and eighth weeks
Method of measurement
PSQI test
Secondary outcomes
empty
Intervention groups
1
Description
participation in Behavioral Placebo Therapy sessions for 8 weeks
Category
Other
2
Description
participation in Cognitive Behavioral Therapy sessions for 8 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa Hospital
Full name of responsible person
Dr Robabeh Soleimani Talemi
Street address
Shafa hospital, Heshmat Square, Rasht
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Abdorrasool Sobhani
Street address
Namjoo street- Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan 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
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
Email
soleimani_dr@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, Rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
Email
soleimani_dr@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani Talemi
Position
Assistant professor of psychiatry
Other areas of specialty/work
Street address
Shafa hospital, Heshmat square, rasht
City
Rasht
Postal code
41939-55599
Phone
+98 13 1666 6268
Fax
Email
soleimani_dr@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)