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The Effectivness of Group Therapy Based on Acceptance and Commitment on Meaning in Life,Distress Tolerance, Pain Self-Efficacy and Quality of Life in Patients whit Multiple Sclerosis (MS)

Protocol summary

Study aim
The Aim of Study Will be to Investigate the Effectiveness of Acceptance and Commitment Group Therapy on Meaning Life, Distress Tolerance , Quality of Life and Pain Self-Efficacy 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,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 Acceptance and Commitment Group Therapy Sessions for 8 Weeks (8 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 (8 two-hour sessions for 8 weeks) will continue Center’s usual care plan of the group.
Main outcome variables
Increase Meaning Life, Distress Tolerance , Pain Self-Efficacy and Improvement of Quality of Life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180218038786N1
Registration date: 2019-02-08, 1397/11/19
Registration timing: registered_while_recruiting

Last update: 2019-02-08, 1397/11/19
Update count: 0
Registration date
2019-02-08, 1397/11/19
Registrant information
Name
Zahra Robati
Name of organization / entity
Semnan University
Country
Iran (Islamic Republic of)
Phone
+98 23 3362 4250
Email address
robati.zahra@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectivness of Group Therapy Based on Acceptance and Commitment on Meaning in Life,Distress Tolerance, Pain Self-Efficacy and Quality of Life in Patients whit Multiple Sclerosis (MS)
Public title
The Effect of Group Therapy Based on Acceptance and Commitment on Meaning Life,Distress Tolerance, Pain Self-Efficacy and Quality of Life in Patients whit 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 being randomly into one of the study groups Diagnosis of MS by a neurologist
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
The allocation method will be simple random. Hiding the assignment using a computer is that the computer creates random numbers between zero and one. If the random number is less than 0/005, the individual will be assigned to the test group, and if the random number is greater than 0/005, the individual will be entered into the control group. In this process, people who enter the study list will not be aware of how the treatment is allocated before the intervention.
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.1397.019

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
Quality of Life Score in Quality of Life Inventory
Timepoint
Measurement of Quality of Life before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
The Short Form Quality of Life Inventory

2

Description
Meaning Life Score in Meaning in Life Question
Timepoint
Measurement of Meaning Life before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Meaning in Life Question

3

Description
Distress Tolerance Score in Distress Tolerance Scale
Timepoint
Measurement of Distress Tolerance before Intervention and 60 Days after the Onset of Acceptance and Commitment Group Therapy.
Method of measurement
Distress Tolerance Scale

4

Description
Pain Self-Efficacy Score in Self Pain Efficacy Inventory
Timepoint
Measurement of Pain Self-Efficacy before Intervention and 60 Days after the Onset of Acceptance and Commitment 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 8 weeks) will continue Center’s usual care plan of the group
Category
Behavior

2

Description
Intervention group: The Intervention group will attend acceptance and commitment group therapy sessions for 8 weeks (8 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
Faezeh Dalalmoghadam
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
f.dalalmoghadam2016@gmail.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
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 Islamic Azad University of Neyshabour
Full name of responsible person
Faezeh Dalalmoghadam
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pajohesh Squar
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319774446
Phone
+98 51 4330 5000
Fax
+98 51 4330 5234
Email
f.dalalmoghadam2016@gmail.com
Web page address
http://www.iau-neyshabur.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 Islamic Azad University of Neyshabour
Full name of responsible person
Faezeh Dalalmoghadam
Position
Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pajohesh Squar
City
Neyshabour
Province
Razavi Khorasan
Postal code
9319774446
Phone
+98 51 4330 5000
Fax
+98 51 4330 5234
Email
f.dalalmoghadam@gmail.com
Web page address
http://www.neyshabur.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
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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