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The Effectiveness of Cognitive- Behavioral Group Therapy (CBGT) on Anxiety, Self-Esteem, Quality of Life, Pain Self-Efficacy and Hope in Patients with Multiple Sclerosis (MS)

Protocol summary

Study aim
The Aim of Study Will be to Investigate the Effectiveness of Cognitive- Behavioral Group Therapy (CBGT) on Anxiety, Self- Esteem, Quality of Life, Pain Self-Efficacy and Hope in Patients with Multiple Sclerosis (MS).
Design
In an Experimental Study With a Pretest-Posttest Control Group Design, 20 Patients With (MS) Will be Selected Through Convenience Sampling Method.
Settings and conduct
The Society for the Protection of Patients With Multiple Sclerosis in Mashhad and Will be Assign to Two Experimental and Control Groups, Each Contain 10 Individuals.
Participants/Inclusion and exclusion criteria
The inclusion criteria: Aged between 20 to 50 years, having at least a high school diploma, Willingness to participate in the study and being randomly into one of the study groups, Diagnosis of MS by a neurologist, Anxiety disorder based on Beck Anxiety Inventory with a score higher than 26,Completing the agreement form. The exclusion criteria: Having physical and mental diseases, Receiving intrudent pharmacological and non pharmacological treatments, Patients with any serious psychological disorders (including psychotic disorders or active substance abuse), Having a neurological disorder other than MS, Education less than fifth elementary.
Intervention groups
Experimental Group: The Intervention group will attend Cognitive- Behavioral Group Therapy Sessions for 6 Weeks (10 sessions of two hour). In General, the Treatment Plan for this Group Will be to at Assess Previous Session Homework, Teaching a New Technique and Giving Homework for Future Session. Control group:The control group simultaneously (10 two-hour sessions for 10 weeks) will continue Center’s usual care plan of the group.
Main outcome variables
Increase Self- Esteem, Hope, Pain Self-Efficacy, Improvement of Quality of Life and Decreased Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150413021727N3
Registration date: 2019-01-02, 1397/10/12
Registration timing: prospective

Last update: 2019-01-02, 1397/10/12
Update count: 0
Registration date
2019-01-02, 1397/10/12
Registrant information
Name
Zahra Gholami
Name of organization / entity
Islamic Azad University of Torbat-e-Jam.
Country
Iran (Islamic Republic of)
Phone
+98 51 5251 0552
Email address
zahragholami014@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Cognitive- Behavioral Group Therapy (CBGT) on Anxiety, Self-Esteem, Quality of Life, Pain Self-Efficacy and Hope in Patients with Multiple Sclerosis (MS)
Public title
The Effect of Cognitive- Behavioral Group Therapy (CBGT) on Anxiety, Self- Esteem, Quality of Life, Pain Self-Efficacy and Hope in Patients with Multiple Sclerosis (MS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 20 to 50 years Having at least a high school diploma Willingness to participate in the study and being randomly into one of the study groups Diagnosis of MS by a neurologist Anxiety disorder based on Beck Anxiety Inventory with a score higher than 26 Completing the agreement form
Exclusion criteria:
Patients with any serious psychological disorders (including psychotic disorders or active substance abuse). Receiving intrudent pharmacological and non pharmacological treatments Having a neurological disorder other than MS Education less than fifth elementary
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects Will be Assigned to Experimental and Control Groups Randomly With the Aid of Random Numbers Table.
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 Committee of Hakim Sabzevari University
Street address
Tohid Shahr ,Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Approval date
2018-11-13, 1397/08/22
Ethics committee reference number
IR.HSU.REC.1397.018

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple Sclerosis (MS)

Primary outcomes

1

Description
Anxiety Score in Beck Anxiety Inventory
Timepoint
Measurement of Anxiety before Intervention and 80 Days after the Onset of Cognitive- Behavioral Group Therapy.
Method of measurement
Beck Anxiety Inventory (BAI)

2

Description
Self- Esteem Score in Coopersmith Inventory
Timepoint
Measurment of Self- Esteem before Intervention and 80 Days after Onset of Cognitive- Behavioral Group Therapy
Method of measurement
Coopersmith Self-Esteem Inventory

3

Description
Quality of Life Score in Quality of Life Inventory
Timepoint
Measurement of Quality of Life before Intervention and 80 Days after the Onset of Cognitive- Behavioral Group Therapy.
Method of measurement
The Short Form Quality of Life Inventory

4

Description
Hope Score in Adult Hope Inventory
Timepoint
Measurement of Hope before Intervention and 80 Days after the Onset of Cognitive- Behavioral Group Therapy.
Method of measurement
Adult Hope Inventory

5

Description
Pain Self-Efficacy Score in Self Pain Efficacy Inventory
Timepoint
Measurement of Pain Self-Efficacy before Intervention and 80 Days after the Onset of Cognitive- Behavioral Group Therapy.
Method of measurement
Self Pain Efficacy Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The control group simultaneously (two-hour sessions for 10 weeks) will continue Center’s usual care plan of the group
Category
Behavior

2

Description
Experimental group: The Intervention group will attend cognitive- behavioral group therapy sessions for 10 weeks (10 sessions of two hour). In general, the treatment plan for this group will be to at assess previous session homework, teaching a new technique and giving homework for future session.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
The Society Protection of Patients With MS
Full name of responsible person
Zahra Robati
Street address
No. 50, Ahmad Abad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9194864361
Phone
+98 51 3844 6347
Fax
+98 51 3844 6348
Email
robati.zahra@yahoo.com
Web page address
https://msmashhad.com/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Hakim Sabzevari University
Full name of responsible person
Ahmad Farzaneh
Street address
Tohid Shahr, Hakim Sabzevari University
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Fax
+98 51 4401 2607
Email
Research@hsu.ac.ir
Web page address
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, Hakim Sabzevari University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Semnan- Mahdishahr
Full name of responsible person
Zahra Robati
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Darband, Mahdishahr
City
Semnan
Province
Razavi Khorasan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
+98 23 3362 6888
Email
robati.zahra@yahoo.com
Web page address
http://psy.semnan.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Tohid Shahr Street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617666666
Phone
+98 51 4441 9050
Fax
+98 51 4441 4244
Email
hsharreh@yahoo.com.au
Web page address
http://www.hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Semnan- Mahdishahr
Full name of responsible person
Zahra Robati
Position
Master of Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Darband, Mahdishahr
City
Mahdishahr
Province
Semnan
Postal code
3564111156
Phone
+98 23 3362 3300
Fax
+98 23 3362 6888
Email
robati.zahra@yahoo.com
Web page address
http://psy.semnan.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No More Information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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