This study was performed to investigate the effect of fordyce happiness model on depression, anxiety, stress, and fatigue of multiple sclerosis patients' .Design of this study was randomized clinical trial. The fordyce happiness program applied in trial group and then stress; anxiety; depression; and fatigue questionnaires completed before and after intervention.Participants of this study included patients and their families that had the main inclusion criteria such as enabling read and write; having age range between 18 - 60; and complete the informed consent and main exclusion criteria include having history of other diseases such as mental disorders include major depression (according to records of the patient and the treating physician) or bipolar disorder; addiction; other neurological disorders; and history of steroid use or relapse during the past 6 weeks. Educational intervention after obtained the consent form applied eight sessions (each sessions: ninety-minute )once a week in trial group and fourteen principle of fordyce happiness model were taught. Specified goals and tasks for each session and feedback was requested.The questionnaires includes demographic and DASS-21 questionnaire for depression, anxiety and stress and Piper for fatigue before and after the program education.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112420064N1
Registration date:2015-04-02, 1394/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-02, 1394/01/13
Registrant information
Name
Fereydoon Khayeri
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1000
Email address
khayeri.f@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of rehabilitation center of Tehran University of Medical Sciences
Expected recruitment start date
2013-05-15, 1392/02/25
Expected recruitment end date
2013-09-16, 1392/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fordyse happiness model on depression, anxiety and fatigue of multiple sclerosis patients
Public title
The effect of fordyse happiness model on depression, stress, anxiety and fatigue of multiple sclerosis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Main inclusion criteria include enabling read and write; having age range between 18 - 60 and complete the informed consent and main exclusion criteria include having history of other diseases such as mental disorders include major depression (according to records of the patient; and the treating physician) or bipolar disorder; addiction; other neurological disorders; and history of steroid use or relapse during the past 6 weeks.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
140
Randomization (investigator's opinion)
N/A
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
Ethic commite of Tehran University of Medical Sciences
Street address
Ethic commite of Vice chancellor of international spinsl cord research center of Tehran University of Medical Sciences, keshavarz Avenue, Imam Khomeini hospital, Reihane bulding, Tehran.
City
Tehran
Postal code
8196131489
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
125899
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Stress
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
DASS21 Standard Questionnaire
2
Description
Anxiety
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
DASS21 Standard Questionnaire
3
Description
fatigue
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
Piper Standard Questionnaires
4
Description
Depression
Timepoint
Baseline; Imediately After; 2 months After
Method of measurement
DASS21 Standard Questionnaire
Secondary outcomes
1
Description
Quality of life
Timepoint
6months After intervention
Method of measurement
SF-36 Standard Questionnaire
Intervention groups
1
Description
after obtaining the consent from from trial group, fordyce happiness program carried out in 8 sessions of 90 minutes once a week and happy principle taught with 14 element.
Specified goals and tasks for each session and requested feedback from the people designed and followed during the program educating. During the meetings of audiovisual equipment and techniques were also used questions and answers.
Category
Behavior
2
Description
In the control group during the routine activities are follow-up and after the collection of questionnaires in in both groups, fordyce happiness program was taught in two sessions in the control group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Multiple Sclerosis Society
Full name of responsible person
Dr.Reza Masoudi
Street address
Number2, first flour, Behesht building, Alkarim Mosque, Bozorgmehr Avenue, Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of rehabilitation center of Tehran University of Medical Sciences
Full name of responsible person
Abbas Norouzi Javidan
Street address
7flour, Vice chancellor for research, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
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 of rehabilitation center of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Freidoon Khayeri
Position
Lecturer, Exective member of Neurosience Department