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Comparison of the Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) and memory specificity training (MEST) on Depression,Anxiety, psychological well-being and cognitive strategies of emotional regulation in Hemodialysis Patients

Protocol summary

Study aim
Reduction Of Psychological Disorders in Patients with Hemodialysis such as Anxiety and Aepression. Increase Control and Emotion Regulation and Psychological Well-Being Hemodialysis Patients. Increased Recognition and the Knowledge of Specialists
Design
Clinical Trial with Intervention and Control Group, a Semi-experimental Design with PRE-TEST , POST- TEST and Follow-up with Control Group, Purposive Sampling and Substitution inIintervention and Control Groups Randomly.
Settings and conduct
The statistical population were of hemodialysis patients referred to hemodialysis centers of Hajar hospital in Tehran in 2017. To collect information after obtaining the necessary permissions, the sample was selected. The sampling method was purposeful. At first, the application form for voluntary participation in hemodialysis centers was distributed among the statistical community. 36 hemodialysis patients were selected in Purposive sampling and then 12 were replaced in each intervention and control group. Subjects were then assigned to education intervention groups and Then questionnaires were distributed among the Subjects and data were analyzed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Hemodialysis,Female, Willingness to Participate and continue Pherapy sessions,Diploma and Higher Education, Not Taking Part in any Other Psychological Treatment Exclusion criteria:Man, Taking Medications that Reduce Consciousness, Trauma or Brain Damage ,Lack of Motivation to Participate in Meetings
Intervention groups
Intervention group: Individuals Undergoing Training on Mindfulness Therapy are Placed in Eight Sessions. Intervention group 2 :Memory Specificity Training in six sessions Control group: There is no Training for this Group
Main outcome variables
Depression, Anxiety, Psychological Well-Being, Cognitive Emotion Regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190202042582N1
Registration date: 2019-05-31, 1398/03/10
Registration timing: retrospective

Last update: 2019-05-31, 1398/03/10
Update count: 0
Registration date
2019-05-31, 1398/03/10
Registrant information
Name
Marziyeh Noorifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3280 3566
Email address
m_nuorifard57@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-20, 1396/01/31
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
2017-04-20, 1396/01/31
Actual recruitment end date
2017-06-21, 1396/03/31
Trial completion date
2018-02-14, 1396/11/25
Scientific title
Comparison of the Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) and memory specificity training (MEST) on Depression,Anxiety, psychological well-being and cognitive strategies of emotional regulation in Hemodialysis Patients
Public title
Comparison of the Effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) and memory specificity training (MEST) on Mental and Emotional Health in Hemodialysis Patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate and continue Therapy Sessions Diploma and Higher Education Not taking Part in any other Psychological Treatment
Exclusion criteria:
Taking Medications that Reduce Ronsciousness Trauma or Brain Damage Lack of Motivation to Participate in Meetings
Age
From 25 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Not 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
Ethics committee of Islamic Azad University-Isfahan(Khorasgan)Branch
Street address
University Blvd.,East Gay Ave., Arghavaniyeh
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.255

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F30-F39
ICD-10 code description
Mental and behavioural disorders

2

Description of health condition studied
Anxiety
ICD-10 code
F40-F48
ICD-10 code description
Mental and behavioural disorders

Primary outcomes

1

Description
Depression Score in Beck Questionnaire
Timepoint
The end of the intervention
Method of measurement
BAI - Beck Depression Inventory

2

Description
Anxiety Score in Beck Questionnaire
Timepoint
The end of the intervention
Method of measurement
BAI - Beck Anxiety Inventory

3

Description
Psychological well-being score in psychological well-being questionnaire
Timepoint
The end of the intervention
Method of measurement
psychological well-being questionnaire

4

Description
Emotion Score in Cognitive Emotion Regulation Questionnaire (CERQ)Questionnaire
Timepoint
The end of the intervention
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The structure of the training sessions is based on memory specificity training (MEST) developed by Maxwell et al. (2015). It consists of 6 sessions one hour and is proposed in six consecutive weeks, including exercises and assignments to remember certain memories. memory specificity training (MEST) is , including psychological training on memory function in relation to the disorder and problems related to it. The most important goal of teaching instruction is that participants, when they recount personal events from the history of memory (personal memory), remind them in a specific and individual ways.
Category
Behavior

2

Description
Intervention group: The structure of treatment sessions based on the Mindfulness Cognitive Therapy Package is an eight-week treatment for up to 12 participants and includes a combination of cognitive meditation exercises.The agenda of the sessions is based on the protocol for treatment of mindfulness therapy (Segal et al., 2002).This treatment includes eight sessions of group training that lasts once a week and lasts for two hours.In this tutorial, patients learn how to interact in a way that is different from their negative thoughts and feelings, and focus on changing their beliefs and thoughts.They also learn how to shape their thoughts, change their habits, rumors, their thoughts, and their negative emotions, become aware of them, and see them in a wider perspective
Category
Behavior

3

Description
Control group: The control group did not participate in any kind of intervention
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital
Full name of responsible person
Mohammad Kamali
Street address
Hajar Hospital.Valiasr intersection.Shahid Beheshti Ave.Teharn.Iran
City
Tehan
Province
Tehran
Postal code
1585737311
Phone
+98 21 8871 0294
Email
m_nuorifard57@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
MS.saadat
Street address
University Blvd., Arghavaniyeh,. East Gay Ave
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m_nuorifard57@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad 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
Islamic Azad University
Full name of responsible person
Marziyeh Noorifard
Position
Ph.D. Student Department of Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Blvd., Arghavaniyeh,. East Gay Ave
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m_nuorifard57@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hamid Taher Neshat Doost
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Facing the Central Building,. Faculty of Education and Psychology,. Isfahan University,. Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 5500
Email
h.neshat@edu.ui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marziyeh Noorifard
Position
Ph.D. Student Department of Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
University Blvd., Arghavaniyeh,. East Gay Ave
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m_nuorifard57@yahoo.com

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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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