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The Effectiveness of Group Metacognitive Therapy on Defense Mechanisms, Resiliency and Self Efficacy of Females with Multiple Sclerosis

Protocol summary

Summary
Objective: This study aims to investigate the effectiveness of cognitive group therapy in cognitive components, resilience, self-efficacy and defensive styles of females with multiple sclerosis. Design: This research is a quasi-experimental study with a pretest-posttest control group design accompanied by a two-step follow-up procedure. Of all the patients with multiple sclerosis referring to the MS Society of Khorasan-e- Razavi in 2014, 30 individuals were selected through available sampling method and were randomly assigned to two experimental and control groups. Implementation: The experimental group underwent metacognitive therapy during 8 weeks while the control group followed the ordinary course of the sessions provided by the MS Society. Metacognition questionnaire-30 (MCQ-30), Connor and Davidson Resilience Scale ‎‎(CD-RISC), Sherer General Self-Efficacy Scale and Defense Style Questionnaire (DSQ) were used in the pretest, posttest and follow-ups.‎ Inclusion criteria consisted of the following: The final diagnosis of developing MS by the neurologist, signing a written consent form to participate in the study, having at least a diploma and achieving scores 1 to 4 in EDSS diagnosed by the neurologist. Exclusion criteria were as follows: Receiving psychological treatments at least one month prior to entering the study, a history of metabolic diseases like thyroid and absence of more than two sessions. Interventions: The experimental group underwent metacognitive therapy during 8 weeks while the control group followed the ordinary course of the MS Society sessions. Metacognition questionnaire-30 (MCQ-30), Connor and Davidson Resilience Scale ‎‎(CD-RISC), Sherer General Self-efficacy Scale and Defense Style Questionnaire (DSQ) were applied in the pretest, posttest and follow-ups. The main outcome variables: Cognitive components, resilience, self-efficacy, defensive styles

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015091624054N1
Registration date: 2015-12-11, 1394/09/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Elahe Asgharkhah
Name of organization / entity
Islamic Azad University of Neyshabur
Country
Iran (Islamic Republic of)
Phone
+98 51 3759 3284
Email address
elaheasgharkhah@ymail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Group Metacognitive Therapy on Defense Mechanisms, Resiliency and Self Efficacy of Females with Multiple Sclerosis
Public title
The Effect Metacognitive Therapy on patient with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion and exclusion criteria: Inclusion criteria: The final diagnosis of developing MS by the neurologist, signing a written consent form to participate in the study, having at least a diploma and achieving scores 1 to 4 in EDSS diagnosed by the neurologist. Exclusion criteria: Receiving psychological treatments at least six month prior to entering the study, a history of metabolic diseases like thyroid and absence of more than two sessions.
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
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
Of all the patients with multiple sclerosis referring to the MS Society of Khorasan-e- Razavi in 2014, 30 individuals were selected through available sampling method and were randomly(Using a table of random numbers) assigned to two experimental and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Azad University of Neyshabur
Street address
Complex of Islamic Azad University of Neyshabur, Pazhouhesh Street, Neyshabur Branch, Khorasan e Razavi, Iran
City
Neyshabur
Postal code
Approval date
2014-08-16, 1393/05/25
Ethics committee reference number
23420701922036

Health conditions studied

1

Description of health condition studied
Multiple SCLEROSIS
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Metacognitive Components
Timepoint
pre test, Post test, two-step follow-up
Method of measurement
Metacognition Questionnaire -30 (MCQ-30)

2

Description
Resiliency
Timepoint
pre test, Post test, two-step follow-up
Method of measurement
Connor and Davidson Resilience Scale (CD-RISC)

3

Description
Self-Efficacy
Timepoint
pre test, Post test, two-step follow-up
Method of measurement
General Self-Efficacy Questionnaire

4

Description
Defense Mechanisms
Timepoint
pre test, Post test, two-step follow-up
Method of measurement
Defense Styles Questionnaire (DSQ)

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group received metacognitive therapy for eight weeks
Category
Behavior

2

Description
the control group spent the routine process of the sessions held by the MS Society.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Society in Khorasan-e- Razavi
Full name of responsible person
Docter Hossein Shareh
Street address
Unit 3, Negin building, Aref Avenue, Ahmadabad Street, Mashhad Khorasan-e- Razavi, Islamic Republic Of Iran
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Investigator
Full name of responsible person
elahe asgharkhah
Street address
Khorasan-e- Razavi
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Hakim Sabzevari University
Full name of responsible person
Dr Hossein Shareh
Position
PhD
Other areas of specialty/work
Street address
Hakim Sabzevari University, Tohid City, Sabzevar, Khorasan-e- Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 7740
Fax
+98 44410460051
Email
Email: hsharreh@yahoo.com.au
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shareh
Position
PhD
Other areas of specialty/work
Street address
Hakim Sabzevari University, Tohid City, Sabzevar, Khorasan-e- Razavi, Iran
City
Mashhad
Postal code
Phone
+98 51 3841 7740
Fax
+98 51 4441 0460
Email
hsharreh@yahoo.com.au
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Neyshabur
Full name of responsible person
elahe Asgharkhah Farkhani
Position
MA student in clinical psychology
Other areas of specialty/work
Street address
Complex of Islamic Azad University of Neyshabur, Pazhouhesh Street, Neyshabur Branch, Khorasan e Razavi, Iran
City
Mashhad
Postal code
91449 94611
Phone
+98 51 3759 3284
Fax
Email
elaheasgharkhah@ymail,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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