Protocol summary

Study aim
Determining the effect of positive thinking techniques on resilience, anxiety and depression and the quality of life of patients with multiple sclerosis (MS)
Design
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 0 on 20 patients, was used for randomization.
Settings and conduct
MS Clinic of Qaim Mashhad Hospital. The analyst was blinded. Patients in the intervention group will undergo group therapy sessions (positive psychological interventions) for 14 sessions of 90 minutes. And in the control group, no psychological treatment will be done for the patients. And during this time, a movie will be played for them. Finally, three questionnaires of resilience and quality of life of patients with MS, before and after the intervention, and Leviband's anxiety, stress and depression questionnaire are evaluated. . After the end of the treatment, the control group will receive two sessions of positive intervention training. The treatment method used will be planned based on the Rashid and Seligman treatment protocol.
Participants/Inclusion and exclusion criteria
Admission: Age between 18-60 years, minimum education diploma, diagnosis of MS, no drug addiction, no psychiatric diseases. Failure to enter: lack of informed consent to participate in the study, failure to participate in at least 2 treatment sessions, failure to complete the questionnaire
Intervention groups
Patients in the intervention group will undergo treatment sessions (positive psychology interventions) for 14 sessions of 90 minutes. Control group: In the control group, no psychological treatment will be done for the patients. And during this time, a movie will be played for them. After the end of the treatment, the control group will receive two sessions of positive intervention training.
Main outcome variables
Resilience; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240515061811N1
Registration date: 2024-06-22, 1403/04/02
Registration timing: prospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Mahshid Mahmoodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3878 2578
Email address
mahmoodi.mahshid@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of positive psychological interventions on resilience, anxiety, depression and quality of life of of Multiple sclerosis patients
Public title
The effect of positive training on resilience and quality of life in patients with multiple sclerosis (MS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum education is diploma History of MS diagnosis No drug addiction Not suffering from psychiatric diseases
Exclusion criteria:
Failure to participate in at least 2 treatment sessions Lack of informed consent to participate in the study Failure to complete the questionnaire
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method will be used to generate a sequence of random numbers. In this method, 5 blocks of size 4 and 10 blocks of size 2 are randomly selected from the combination of letters A and B with a table of random numbers. The list of blocks with size two is 1:AB and 2:BA. The list of blocks with size four is: 1:AABB, 2:ABBA, 3:BBAA, 4:BAAB, 5:BABA, 6:ABAB. To select blocks of size 2, 10 numbers are randomly selected from the table of random numbers, then if this number is from 0 to 4, the first block is selected, and if the number is from 5 to 9, the second block is selected. To select blocks of size 4, 5 numbers between 1 and 6 are randomly selected from the table of random numbers, then if this number is 1, the first block is size 4 and if the selected number is 2, then the second block and so on for other blocks. are selected.
Blinding (investigator's opinion)
Single blinded
Blinding description
This randomized, single-blind clinical trial will be conducted with a control group in patients referred to the MS clinic of Ghaem Hospital. Blinding means that the analyst is not aware of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ibne Sina Hosp., Horre Ameli Ave., Toos Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.401

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
Endurance of MS patients
Timepoint
Before and after the intervention
Method of measurement
Connor and Davidson Resilience Questionnaire

2

Description
Quality of life of MS patients
Timepoint
Before and after the intervention
Method of measurement
Leviband Questionnaire (DASS21)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: group therapy sessions (positive psychology interventions), for 14 weekly sessions of 90 minutes, each client determines his personality strengths from the positive introduction he has written, and about the conditions that these strengths have in the past He has helped, discusses and talks.
Category
Treatment - Other

2

Description
Control group: no psychological treatment will be done for the patients. And during this time, a movie will be played for them. After the end of the treatment, the control group will receive two sessions of positive intervention training.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ibne Sina Hospital
Full name of responsible person
Zanireh salimi
Street address
Toos Ave, Horre Ameli Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3711 2709
Email
SalimiZN@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreishi Department, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91375
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Zanireh Salimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Horre Ameli Blvd., Toos Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3712 4452
Email
SalimiZN@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zanireh Salimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Horre Ameli Blvd., Toos Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3712 4452
Email
SalimiZN@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahshid Mahmudi
Position
Psychiatry Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Horre Ameli., Toos Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
83134- 91959
Phone
+98 51 3712 4452
Email
Mahmoodi.mahshid@gmail.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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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