Protocol summary

Study aim
Comparison of the effectiveness of reality therapy and positive psychotherapy on emotional reactions, quality of life, and sleep quality of patients with multiple sclerosis
Design
The research is quasi-experimental with pre-test and post-test designs for two experimental groups and one control group. The clinical trial consisted of 30 members for intervention groups and 15 members for control group (randomized parallel groups). The first stage will be performed as available and the second stage will be randomly performed and patients will receive three questionnaires of emotional reactions, quality of life and sleep quality. The intervention process was performed on experimental groups in 8 sessions, then both experimental and control groups will fill all three questionnaires again as post-tests, and the data related to these 45 individuals will be analyzed.
Settings and conduct
The research will be carried out in Mehr-Ara Clinic with the permission of the Guilan MS Association and under the supervision of the Guilan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
45 female patients with MS who are the members of Guilan MS Association. The selecting criteria: age between 17 and 55 years, having literacy, not being in the acute stage of the disease, not having a history of hospitalization due to mental illnesses, regular participation in medical meetings, not being addicted to any drugs. no hearing or speech issues.
Intervention groups
There are two groups of reality therapy and positive psychotherapy, and one control group that does not receive any intervention.
Main outcome variables
Emotional reactions; Quality of life; Sleeping quality

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200616047804N1
Registration date: 2020-07-16, 1399/04/26
Registration timing: retrospective

Last update: 2020-07-16, 1399/04/26
Update count: 0
Registration date
2020-07-16, 1399/04/26
Registrant information
Name
Seyyad Hadi Rafiee
Name of organization / entity
Department of Psychology, Ardabil Branch, Islamic Azad University, Ardabil, Iran
Country
Iran (Islamic Republic of)
Phone
+98 13 3314 2921
Email address
hrafiee1363@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-05-04, 1399/02/15
Actual recruitment start date
2020-05-23, 1399/03/03
Actual recruitment end date
2020-05-28, 1399/03/08
Trial completion date
2020-06-30, 1399/04/10
Scientific title
The Effectiveness of Reality Therapy & Positive psychotherapy on Emotional Reactions and the Quality of Life and Sleep of Female Patients with Multiple Sclerosis
Public title
The Effectiveness of Reality Therapy & Positive psychotherapy on Emotional Reactions and the Quality of Life and Sleep of Patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 17 and 55 years old Reading and writing literacy Not being in the critical level of the disease Not being hospitalized due to mental illnesses Regular participation in therapeutic meetings
Exclusion criteria:
Not participating in the therapeutic meetings or using other psychotherapy methods during the research No drug addiction Having no hearing or speaking issues Do not attend a maximum of one-third of the training sessions
Age
From 17 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
About 60 female patients who are members of the MS Association of Guilan Province were introduced to the researcher by the director of the association according to the criteria for admission. After placing the names of the individuals individually in the lottery bag, 45 people in three groups of 15 (two experimental groups and one control group) were randomly removed from the lottery bag by the clinic secretary.
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 Guilan University of Medical Sciences
Street address
Head Office of Guilan University of Medical Sciences - Fifth Floor of central office, in front of Azodi Stadium, Namjoo St, Rasht; Contact Number: 33310209- 33329706 - 013 Telegram: 33329706; Email: ravabetomomi@gums.ac.ir
City
Rasht
Province
Guilan
Postal code
1311141937
Approval date
2020-05-27, 1399/03/07
Ethics committee reference number
IR.GUMS.REC.1399.067

Health conditions studied

1

Description of health condition studied
Multiple Sclerosis.
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
emotional reactions
Timepoint
Beginning of study, end of study (eighth week)
Method of measurement
depression, anxiety and stress questionnaire (DASS21)

2

Description
quality of life
Timepoint
Beginning of study, end of study (eighth week)
Method of measurement
MS quality of life scale (MSIS-29)

3

Description
sleep quality
Timepoint
Beginning of study, end of study (eighth week)
Method of measurement
sleep quality questionnaire (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
In this study, group reality therapy will be used. In this study, 30 female patients who are members of Guilan Province MS Association were randomly selected and were divided to two experimental and control groups. The data collection and then intervention on the experimental group were performed for eight 90-minute sessions during a 2-month period and during this period no intervention will be applied to the control group.
Category
Treatment - Other

2

Description
In this study, the method of positive psychotherapy will be used. The number of samples in this study are 30 female patients who are members of the MS Association of Guilan Province are randomly selected and divided into two groups of 15 people for experimental and control one. Data collection and then intervention on the experimental group will be performed for 8 sessions of 90 minutes for 2 months and during this period no intervention will be applied on the control group.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan MS Association
Full name of responsible person
Seyyed Hadi Rafiee
Street address
Guilan MS Association، Nabat Building, Poursina Crossroads, Poursina Street, Rasht, Iran.
City
Rasht
Province
Guilan
Postal code
4193743138
Phone
+98 13 3333 7656
Fax
+98 13 3332 6065
Email
Hrafiee1363@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Department of Psychology,Islamic Azad University of Ardabil, Ardabil, Iran
Full name of responsible person
Dr. Aref Jalili Irani, Director of Research and Technology, Islamic Azad University (Ardabil)
Street address
Basij Square, Islamic Azad University of Ardabil, Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8029
Fax
+98 45 3372 7799
Email
info@iauardabil.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Department of Psychology, Islamic Azad University, Ardabil Branch, Ardabil, Iran
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Islamic Azad University of Ardabil, Ardabil, Iran
Full name of responsible person
Dr. Somayyeh Taklavi
Street address
Basij Square, Islamic Azad University of Ardabil, Ardebil, Iran
City
Ardrbil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8029
Email
staklavi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Department of Psychology - Islamic Azad University of Ardabil, Ardabil, Iran
Proportion provided by this source
100
Public or private sector
Private
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
Department of Psychology, Islamic Azad University, Ardabil Branch, Ardabil, Iran
Full name of responsible person
Seyyed Hadi Rafiee
Position
PhD Student in General Psychology, Department of Psychology, Islamic Azad University, Ardabil Branc,
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Basij Square, Islamic Azad University Complex, Ardabil Branch، Ardabil, Iran
City
Ardebil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8029
Email
Hrafiee1363@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Psychology, Islamic Azad University, Ardabil Branch, Ardabil, Iran
Full name of responsible person
Seyyed Hadi Rafiee
Position
PhD Student in Psychology, Department of Psychology, Ardabil Branch, Islamic Azad University, Ardabi
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Basij Square, Islamic Azad University of Ardabil, Ardabil Twon
City
Ardebil
Province
Ardabil
Postal code
5615731567
Phone
+98 45 3372 8029
Email
Hrafiee1363@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Department of Psychology, Ardabil Branch, Islamic Azad University, Ardabil, Iran
Full name of responsible person
Seyyed Hadi Rafiee
Position
PhD Student in Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Psychology,7th Floor, Imam Sajjad Clinic, in front of Azodi Stadium, Rasht, Iran
City
Rasht
Province
Guilan
Postal code
5615731567
Phone
+98 13 3314 2921
Fax
+98 45 3372 7799
Email
Hrafiee1363@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Not applicable
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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