Protocol summary

Summary
1. Objectives: To assess the effectiveness of Acceptance and commitment therapy based on well-being and psychological adjustment of patients with multiple sclerosis. 2. Design: This study is experimental with pre and post-test and follow-up, study is not blind. 3. Setting and conduct: The study population All women with MS referred to the MS Society is the city of Kermanshah, of which 30 samples randomly into two groups (n = 15) and control ( 15) are randomly assigned. 4. Participants including major eligibility criteria: Inclusion criteria: patients with MS being; woman; having a higher education cycle Exclusion criteria: having a physical illness and other mental disorders; being illiterate 5. Intervention: experimental group received 8 sessions of treatment are based on commitment and acceptance, but the control group did not receive psychological services. 6. main outcome measures (variables): : the promotion of psychological well-being and psychological adjustment in patients with MS is that the questionnaire California Psychological well-being and psychological adjustment can be calibrated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020625433N2
Registration date: 2016-03-09, 1394/12/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Fatemeh Dehghan
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 1439
Email address
srghasemi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences Kermanshah, Vice chancellor for research
Expected recruitment start date
2016-05-31, 1395/03/11
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of commitment and acceptance based therapy on adjustment psychological and well-being of women with MS of Kermanshah
Public title
The effectiveness of commitment and acceptance based therapy on adjustment psychological and well-being of women with MS
Purpose
Treatment
Inclusion/Exclusion criteria
Entry conditions: patients with multiple sclerosis; female; cycle of higher education Exclusion criteria:physical illness; other mental disorders; illiteracy.
Age
From 95 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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
University of Medical Sciences Kermanshah, Ethics Committee
Street address
Building No. 2, Kermanshah University of Medical Sciences, Iran martyr Beheshti, Kermanshah
City
Kermanshah
Postal code
6715847141
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
kums.rec.1394.327

Health conditions studied

1

Description of health condition studied
MS
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Psychological Well-Being
Timepoint
A month before the intervention, after the intervention, six months after the intervention
Method of measurement
Psychological well-being questionnaire

2

Description
adjustment psychological
Timepoint
A month before the intervention, after the intervention, six months after the intervention
Method of measurement
California adjustment psychological

Secondary outcomes

empty

Intervention groups

1

Description
examination group: treatment based on commitment and acceptance during the eight 90-minute sessions for two months
Category
Behavior

2

Description
Control group: Other therapeutic interventions except for psychological intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Society Farabi Hospital in Kermanshah
Full name of responsible person
Masoud Moradi
Street address
Farabi Hospital, Dolat Abad road, Kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Medical Sciences Kermanshah, Vice chancellor for research
Full name of responsible person
Kyrus Hamzehee
Street address
Building No. 2, Kermanshah University of Medical Sciences, Iran martyr Beheshti, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Medical Sciences Kermanshah, 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
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan
Position
Researcher
Other areas of specialty/work
Street address
Part 18, Block 2, alleys action 21, Tang Knsh streets, Zfr- town, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3432 1439
Fax
Email
fateme.dehghan1368@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh dehghan
Position
MA
Other areas of specialty/work
Street address
Part 18, Block 2,alleys action 21, Tang Knsh streets, Zfr- town, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3432 1439
Fax
Email
fateme.dehghan1368@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Fatemeh Dehghan
Position
MA
Other areas of specialty/work
Street address
Part 18, Block 2, alleys action 21, Tang Knsh streets, Zfr- town, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3432 1439
Fax
Email
fateme.dehghan1368@gmail.com
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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