Protocol summary

Study aim
Reduction of Psychological Disorders in Patients with Hemodialysis such as Anxiety and Aepression. Increased the Knowledge of Specialists about Psychological Problems and their Treatment in Hemodialysis Patients
Design
Clinical trial with 3 intervention and control groups, semi-experimental with pretest-posttest design and follow up in the control group, purposive sampling and non-random assignment to intervention and control groups
Settings and conduct
The research population included patients under hemodialysis referring to Hajar Hospital of Tehran in 2017. For data collection, sample selection was done. Sampling was done by purposive method. On this basis, first application form of voluntary participation was distributed among the population in hemodialysis treatment centers, and 48hemodialysis patients were selected by purposive sampling. Then, 12 people were assigned to each of the control and intervention groups. Subjects were then assigned to education intervention group . Then, questionnaires were distributed among the subjects and data analysis was done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: undergoing hemodialysis; diploma and higher education; not taking part in any other psychological treatment. Exclusion criteria: male gender; taking medications that reduce consciousness; trauma or brain damage; lack of motivation to participate in meetings.
Intervention groups
Intervention group1: individuals undergoing training on mindfulness combination with memory specificity training (MB-MEST) are placed in ten sessions. Intervention group 2: individuals undergoing training on mindfulness therapy are placed in eight sessions. Intervention group 3: memory specificity training (MEST) in six sessions. Control group: there is no training for this group.
Main outcome variables
Depression; anxiety; well-being; physical symptoms; emotion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190202042582N4
Registration date: 2019-08-27, 1398/06/05
Registration timing: retrospective

Last update: 2019-08-27, 1398/06/05
Update count: 0
Registration date
2019-08-27, 1398/06/05
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
A Comparative Study of the Effectiveness (mindfulness combination with memory specificity training (MB-MEST) with mindfulness & memory specificity training (MEST) on Anxiety, Depression and Mental Well-being, Physical Symptoms, and Cognitive Emotion Regulation Strategies in Hemodialysis Patients
Public title
The Effectiveness of Three Treatments (mindfulness combination with memory specificity training (MB-MEST)) with mindfulness & memory specificity training (MEST) on Mental and Physical Health of 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 Consciousness 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: 48
Actual sample size reached: 48
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
Major depr
ICD-10 code description
F32.1

2

Description of health condition studied
Anxiety
ICD-10 code
Generalize
ICD-10 code description
F41.1

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 a Mindfulness-Based Cognitive Therapy Package integrated with the MEST Proprietary Memory Training Package, designed and tested by researchers (Nouri Fard, Neshat Dost and Sajjadian, 2017). Which includes 10 sessions of training and therapy in 10 weeks and each session is 2 hours. In this therapeutic package, patients undergoing hemodialysis are undergoing training in a mind-boggling training program with a specialist memory training program, In this intervention, the program utilizes the integration of the protocol of treatment of mindfulness and the treatment protocol of personalized memory education, while treating it challenging the memory, thoughts and irrational beliefs of chronic disease with depression and anxiety. Emotional regimes associated with unresectable renal therapy, positive thoughts, substitute negative thoughts.
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
Intervention group: Participants in the intervention group included 12 hemodialysis patients, trained with specialist memory education package designed by Maxwell et al. (2015), including 6 sessions. The goal is to retrieve autobiographical memories. After completing the training, the subjects responded to the questionnaires.
Category
Behavior

4

Description
Control group: The control group did not participate in any kind of intervention
Category
N/A

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
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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