Protocol summary

Summary
Objective: This study has been conducted to investigate the effectiveness of cognitive behavior therapy on severity of pain and psychological distress among women with chronic back pain. Method: This research was conducted by using semi- experimental study with pretest-posttest design, using control group. So, from females with chronic back pain who appointed in Emam Khomeini hospital and a private clinic in Tehran in 2010, 30 participants were selected and randomly assigned in two equal experimental and control groups. Experimental group experienced 12 weeks over 90 minutes of Turk and Free cognitive behavior therapy, while control group were just followed. All of the participants completed the items of DASS, and pain scales prior to and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110143457N4
Registration date: 2012-04-16, 1391/01/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-04-16, 1391/01/28
Registrant information
Name
Masuod Janbozorgi
Name of organization / entity
Behavioral Science Research Center, Shahid Beheshti Medical University
Country
Iran (Islamic Republic of)
Phone
+98 919 151 9526
Email address
psychjan@gmail.com
Recruitment status
Recruitment complete
Funding source
Pyame Noor University
Expected recruitment start date
2010-04-04, 1389/01/15
Expected recruitment end date
2010-05-07, 1389/02/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of cognitive behavior therapy on declining severity of pain and psychological distress among women with chronic back pain
Public title
The efficacy of cognitive behavior therapy on declining severity of pain and psychological distress among women with chronic back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Included criteria: being female, having chronic back pain, higher pain score of pain scale , non of surgery background, completing consent paper Excluded criteria having personality disorder, any psychological disorder, any medical problems, taking any analgesics
Age
From 20 years old to 45 years old
Gender
Female
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Payame Noor University
Street address
Nejatollahi st.
City
Tehran
Postal code
Approval date
2009-02-18, 1387/11/30
Ethics committee reference number
پ0089-130

Health conditions studied

1

Description of health condition studied
Chronic back pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Declining pain
Timepoint
Prior to and after intervention
Method of measurement
Quebec Back Pain Disability Scale

Secondary outcomes

1

Description
Psychological Distress
Timepoint
Prior to and after intervention
Method of measurement
Depression, Anxiety, Stress Scale(DASS)

Intervention groups

1

Description
Intervention plan is based on Turk(2004) and Free (2007) cognitive- behavior and it is for the control of chronic pains and included 12 sessions over 90 minutes
Category
Treatment - Other

2

Description
They had no treatment and were in waiting list
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Dr. Yousefi
Street address
Keshavarz Boulvar. Emam Khomeini Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hooze and University
Full name of responsible person
Gharavi
Street address
Qum-
City
Qum
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hooze and 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
Hoze and Daneshgah
Full name of responsible person
Masoud Janbozorgi
Position
MSc, in psychology
Other areas of specialty/work
Street address
12- negar - akhteyareyee
City
Tehran
Postal code
Phone
+98 21 2257 2274
Fax
Email
Janbozorgi@sbmu.ac.irpsychjan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hawze and Daneshgah
Full name of responsible person
Masoud Janbozorgi
Position
MSc, in psychology
Other areas of specialty/work
Street address
12- negar- akhteyareye
City
Tehran
Postal code
Phone
+98 21 2257 2274
Fax
Email
janbozorgi@sbmu.ac.irpsychjan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hoze and Daneshgah
Full name of responsible person
Masoud Janbozorgi
Position
MSc, in psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Janbozorgi@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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