This study aims to compare the efficacy of two following approaches in the treatment of tension headache as one of the most common headache types; Stress Inoculation Training (SIT) and pharmacotherapy. From those patients who referred to neurology Clinic of Alavi Hospital (Ardabil City) and physicians offices during June and July of 2003 complaining chronic headache, 30 patients were randomly selected and divided into three groups; two intervention groups and one control group. The patients in the first group underwent pharmacotherapy (with Amitriptylline 60mg at night for 6 months) and the second group received SIT intervention (in the three phases as noted in the SIT protocol). Third group received no intervention (control group). Headache indices (frequency, severity, and duration) were evaluated for all subjects in three phases before treatment, shortly after treatment and one month later using Headache Daily questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810022913N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Parviz Molavi
Name of organization / entity
Ardabil University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
p.molavi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan Univeristy
Expected recruitment start date
2003-08-12, 1382/05/21
Expected recruitment end date
2003-11-12, 1382/08/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the efficacy of stress inoculation training (SIT) with pharmacotherapy in the management of chronic tension headache
Public title
The comparison of the efficacy of stress inoculation training (SIT) with pharmacotherapy in the management of chronic tension headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having a chronic pain, no brain damage, and no other psychiatric disorder
Exclusion criteria: recent medical prophylaxis for tension headache, recent psychotherapy, recent pregnancy, migraine headache longer than one day per month, pain disorders (like Arthritis), mental disorder and finally patients disinclination to for the rest of cooperation
Age
From 20 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Isfahan University
Street address
Hezar Jarib Street
City
Isfahan
Postal code
Approval date
2001-01-28, 1379/11/09
Ethics committee reference number
2452-1735
Health conditions studied
1
Description of health condition studied
Tension headache
ICD-10 code
G44.2
ICD-10 code description
Chronic tension-type headache
Primary outcomes
1
Description
frequency, severity and duration of headache
Timepoint
before treatment, after treatment and 1 month after treatment
Method of measurement
headche daily questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group: Stress Inoculation training
Category
Behavior
2
Description
In the Intervention group: Amitriptyline 60mg at night for six months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurlogy Clinic of Alavi Hospital
Full name of responsible person
Street address
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Psychology School of Isfahan University
Full name of responsible person
Ahmad Ahmadi
Street address
Hezar Jarib Street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Psychology School of Isfahan University
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
Ardabil University of Medical Sciences
Full name of responsible person
Dr Parviz Molavi
Position
Associate Professor
Other areas of specialty/work
Street address
Fatemi Hospital
City
Ardabil
Postal code
Phone
00982188614346-00982188614348
Fax
Email
p.molavi@arums.ac.ir p.molavi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Parviz Molavi
Position
Associate Professor of Psychiatry
Other areas of specialty/work
Street address
Fatemi Hospital
City
Ardabil
Postal code
Phone
00982188614346-00982188614348
Fax
Email
p.molavi@arums.ac.ir p.molavi@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)