Protocol summary

Study aim
investigate The effectiveness of Stress Management With Cognitive-Behavioral Approach on Distress Tolerance and Cognitive Emotion Regulation Strategies in patients with Multiple Sclerosis
Design
Clinical trial with control group, randomized, phase 2 on 30 patients,
Settings and conduct
Cognitive-behavioral stress management treatment sessions will be held in groups for 120 minutes at the Chronic Disease Care Research Center of the School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences. After 10 sessions of treatment, all subjects (experiment and control groups) will answer the questions of fatigue questionnaires and coping styles again in one post-test session. In order to observe the ethical principles in the research, after the intervention, briefing sessions will be held for the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: 18-45 years old, definitive diagnosis by a neurologist, informed consent to participate in the study Exclusion criteria included: receiving psychiatric treatment, absence of more than two sessions in educational interventions, willingness to leave the study
Intervention groups
The strategies and techniques used in the sessions are taken from Anthony, Ironson, and Schneiderman, a practical guide to cognitive-behavioral stress management, written in 2007 and translated by Al-Mohammad, Jokar, and Neshat Doost in 2009. The number of sessions is 10 sessions and the duration of the sessions is 120 minutes. While each session consists of two parts: one part includes stress management techniques that form the cognitive part of stress management therapy and the other part, relaxation exercises that teach the behavioral part of stress management treatment.
Main outcome variables
Stress Management With Cognitive-Behavioral Approach, Distress Tolerance, Cognitive Emotion Regulation Strategies,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210414050967N1
Registration date: 2021-05-08, 1400/02/18
Registration timing: retrospective

Last update: 2021-05-08, 1400/02/18
Update count: 0
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Mohammadreza Pirmoradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 0418
Email address
pirmoradi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2017-01-20, 1395/11/01
Trial completion date
2017-04-21, 1396/02/01
Scientific title
The effectiveness of Stress Management With Cognitive-Behavioral Approach on Distress Tolerance and Cognitive Emotion Regulation Strategies in patients with Multiple Sclerosis.
Public title
Effect of Stress Management in Multiple Sclerosis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All MS patients are members of Ahwaz MS Association. Age range between 18 and 45 years Have at least a diploma Definitive diagnosis of the disease by a neurologist
Exclusion criteria:
Non-membership in Ahwaz MS Association. Age under 18 and over 45 years Having an undergraduate education
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple random sampling method was selected. If a sample of size n is selected from a community of size N in such a way that each possible sample of n has the same chance of being selected, it is called simple random sampling. For this purpose, The names of patients with a fatigue score higher than 36 were written in the list and a code was considered for each patient regardless of the specific order. Then all patients with even codes were selected as a sample.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Iran, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2016-09-15, 1395/06/25
Ethics committee reference number
ajums.REC.1392.60

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
Distress Tolerance
Timepoint
Before and after the intervention (pre-test and post-test)
Method of measurement
Distress Tolerance Scale

2

Description
Cognitive Emotion Regulation Strategies
Timepoint
Before and after the intervention (pre-test and post-test)
Method of measurement
Cognitive Emotion Regulation Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive-behavioral stress management treatment during 10 120-minute group sessions performed weekly.
Category
Behavior

2

Description
Control group: Does not receive intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
انجمن ام اس اهواز
Full name of responsible person
Hani Rahimi
Street address
بلوار امام خمینی، کوچه 31
City
Evaz
Province
Fars
Postal code
74331-84799
Phone
+98 71 5251 7627
Email
hani.psy86@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hani Rahimi
Street address
Imam Khomeini Boulevard, 31 Alley
City
Evaz
Province
Fars
Postal code
74331-84799
Phone
+98 71 5251 7627
Email
hani.psy86@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ahwaz University of Medical Sciences
Proportion provided by this source
1
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
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Rahimi
Position
دانشجوی دکترا
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
بلوار امام خمینی، کوچه 31
City
Evaz
Province
Fars
Postal code
74331-84799
Phone
+98 71 5251 7627
Email
hani.psy86@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Rahimi
Position
دانشجوی دکترا
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
بلوار امام خمینی، کوچه 31
City
Evaz
Province
Fars
Postal code
74331-84799
Phone
+98 71 5251 7627
Email
hani.psy86@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Rahimi
Position
دانشجوی دکترا
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
بلوار امام خمینی، کوچه 31
City
Evaz
Province
Fars
Postal code
74331-84799
Phone
+98 71 5251 7627
Email
hani.psy86@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data of this project will be available for researchers working in academic and scientific institutes
Under which criteria data/document could be used
Any use of data must be done in coordination with the developer
From where data/document is obtainable
Shahid Chamran University of Ahvaz
What processes are involved for a request to access data/document
Applicants should first correspond with the responsible author by e-mail and if possible, the desired information will be provided
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