The purpose of this study is to evaluate the effectiveness of cognitive-behavioral group therapy on quality of life in patients with rheumatoid arthritis.
A randomized single blind design will be employed in which the participants will be drawn from a rheumatology clinic in Arak.
Eligibility is defined as documented diagnosis of rheumatoid arthritis for at least one but no more than eight years, female aged 18 to 65 years and Disease Activity Score(DAS28) ≤5.1.
Patients with DAS28 >5.1 in follow-up, history of debilitating medical conditions or mental illnesses and occurrence of stressful life events will be excluded.
A sample size of 30 participants will be randomized in group cognitive behavioural therapy plus standard pharmaceutical care and standard pharmaceutical care conditions.
Group cognitive behavioral therapy consists of twelve weekly sessions about 90 minutes each according to manuals of Cognitive Therapy of Chronic Pain and Cognitive-Behavioral Interventions for Arthritis Pain Management.
Intervention course will be three months.
Primary outcome will be physical and mental components of quality of life measured before and after the 12-weeks intervention.
Disability, pain, fatigue, anxiety and depression will be measured as secondary outcomes of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010531711N2
Registration date:2017-04-05, 1396/01/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Mohsen Ghasemi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3638
Email address
m.ghasemi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Office of the Vice-chancellor for Research, Dr. Mohammad Rafiei
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Cognitive-Behavioral Group Therapy on Quality of Life in Patients With Rheumatoid Arthritis
Public title
Effect of Group Psychotherapy in Patients With Rheumatoid Arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosed with rheumatoid arthritis of at least one year duration by a rheumatologist according to American College of Rheumatology criteria; disease duration of less than 8 years;18 to 65 years for age; female patients; be able to read and write and completed at least 5 grades in elementary school; Disease Activity Score(DAS28) ≤5.1; Body Mass Index(BMI) <35; signed informed consent
Exclusion criteria: A DAS28 >5.1 in follow-up; history of debilitating medical conditions including chronic obstructive pulmonary disease, end stage renal disease, epilepsy, migraine, multiple sclerosis, malignant neoplasms, AIDS, amputated limb and pregnancy; debilitating mental illnesses including major depressive disorder, bipolar mood disorder and psychotic disorders; occurrence of stressful life events including death of a first-degree relative, imprisonment, divorce, addiction, car accident or fire in the course of the study
Age
From 18 years old to 65 years old
Gender
Female
Phase
2
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
Ethics Committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences Complex, Basij Square, Arak
City
Arak
Postal code
3848176941
Approval date
2015-08-09, 1394/05/18
Ethics committee reference number
IR.ARAKMU.REC.1394.121
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05, M06
ICD-10 code description
Seropositive rheumatoid arthritis, Other rheumatoid arthritis
Intervention condition consists of 12 weekly sessions of group cognitive behavioural therapy about 90 minutes each according to manuals of Cognitive Therapy of Chronic Pain and Cognitive-Behavioral Interventions for Arthritis Pain Management in addition to standard pharmaceutical care
Category
Behavior
2
Description
Control condition consists of standard pharmaceutical care.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Specialty and Subspecialty Polyclinic
Full name of responsible person
Nima Tavakoli
Street address
Imam Reza Specialty and Subspecialty Polyclinic, Shahid Shiroodi Street, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences, Office of the Vice-chancellor for Research
Full name of responsible person
Mohammad Rafiei, Vice-chancellor for Research
Street address
Office of the Vice-chancellor for Research, Arak University of Medical Sciences Complex, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences, Office of the Vice-chancellor for Research
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
Arak University of Medical Sciences
Full name of responsible person
Nima Tavakoli
Position
Resident in Psychiatry
Other areas of specialty/work
Street address
Amirkabir Education and Treatment Center, Parastar Square, Alam al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 4717
Fax
Email
drnimatavakoli@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohsen Ghasemi
Position
M.D., Assistant Professor of Psychiatry
Other areas of specialty/work
Street address
Arak University of Medical Sciences Complex, Basij Square
City
Arak
Postal code
Phone
+98 86 3417 3638
Fax
Email
m.ghasemi@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nima Tavakoli
Position
Resident in Psychiatry
Other areas of specialty/work
Street address
Amirkabir Education and Treatment Center, Parastar Square, Alam al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 4717
Fax
Email
drnimatavakoli@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)