Protocol summary

Study aim
Investigate the effectiveness of group intervention focused on intolerance of uncertainty on psychological distress and quality of life in multiple sclerosis patients
Design
Clinical trial with control group, randomized, phase 2 on 60 patients
Settings and conduct
Group therapy sessions focusing on the inability to tolerate uncertainty and cognitive-behavioral therapy were conducted online and through Skype software during 12 weekly sessions. At the end of the intervention and in the post-test and follow-up phase, all three groups again completed the research questionnaires online.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: definitive diagnosis of the disease by a neurologist, age range 18-55 years, informed consent to participate in the study, non-inclusion requirements include: undergraduate education and severe psychiatric disorders (psychotic disorders or bipolar disorder) based on DSM_5, Exclusion criteria included: recurrence of the disease, absence of more than three sessions in educational interventions and willingness to leave the study.
Intervention groups
Group intervention focused on intolerance of uncertainty, based on the protocol of Molton et al., Which was performed in 12 sessions of 2 hours per week. In these sessions, the role of uncertainty in MS, effective strategies to increase tolerance of uncertainty such as mindfulness meditation and acceptance and awareness of life values and following them were discussed. Cognitive-behavioral group therapy is based on the protocol of Free et al., Which was performed in 10 sessions of 2 hours per week. The content of the sessions includes identifying cognitive distortions about the disease and teaching cognitive techniques to challenge these distortions and respond to negative thoughts by evaluating and finding more useful options.
Main outcome variables
psychological distress, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210414050967N2
Registration date: 2022-03-12, 1400/12/21
Registration timing: retrospective

Last update: 2022-03-12, 1400/12/21
Update count: 0
Registration date
2022-03-12, 1400/12/21
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
2020-12-29, 1399/10/09
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
2020-12-29, 1399/10/09
Actual recruitment end date
2021-04-03, 1400/01/14
Trial completion date
2021-10-06, 1400/07/14
Scientific title
The effectiveness of group intervention focused on intolerance of uncertainty on psychological distress and quality of life in multiple sclerosis patients
Public title
Effect of intervention focused on intolerance of uncertainty in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of the disease by a neurologist Age range 18 to 55 years Have at least a diploma Having a medical record in the MS community Score between 0 and 5 on the Extensive Disability Status Scale (EDSS) Having the necessary facilities for online participation in various stages of research (laptop or Mobile with high-speed Internet connection)
Exclusion criteria:
Severe psychiatric disorders (psychotic or bipolar disorders) based on DSM_5 drug use disorder based on DSM-5 the presence of a physical illness that prevented them from attending treatment sessions.
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Considering the inclusion and non-inclusion criteria, 60 patients who wished to participate in the study (with written consent) were randomly substituted into three groups of 20 intervention (the group that received routine drug therapy and group intervention focused on intolerance of uncertainty), the first control (group receiving routine drug therapy and cognitive-behavioral group therapy as gold standard) and the second control (group receiving only routine drug therapy) were divided. The method of randomization was that first, codes were assigned to all three groups and then, by drawing lots, the order of the groups was determined as the intervention focused on intolerance of uncertainty, cognitive-behavioral therapy and waiting list. In the next step, the code was assigned to the sample people. In one pot, 60 codes (20 codes for each group) and in another pot, 60 people were sampled. Then, randomly, a piece of paper was taken out of each pot, and based on the code that came out, the patient was placed in the group corresponding to the same code, until the codes were completed. Thus, 20 people were placed in each of the mentioned groups.
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 Iran University of Medical Sciences
Street address
Hemmat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-12-27, 1399/10/07
Ethics committee reference number
IR.IUMS.REC.1399.1073

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
psychological distress
Timepoint
Before and after the intervention (pre-test and post-test), Three-month follow-up
Method of measurement
Depression, Anxiety, Stress Questionnaire (DASS-21)

2

Description
Quality of life
Timepoint
Before and after the intervention (pre-test and post-test), Three-month follow-up
Method of measurement
MS Quality of life (MSQoL-54)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Group therapy focused on the inability to tolerate uncertainty was based on the protocol of Molton et al., performed in 12 sessions of two hours on a weekly basis. It is designed considering some basic principles of cognitive-behavioral therapy as well as acceptance and commitment therapy. This treatment focuses on recognizing the controllable and uncontrollable aspects of MS, setting personal goals for accepting the disease regardless of uncertainty, as well as mindfulness exercises, and finding ways to live alongside personal values despite uncertainty about the future.
Category
Behavior

2

Description
Control group: Cognitive-behavioral group therapy was based on the protocol of Van den Akker et al., performed in 12 sessions of two hours on a weekly basis. This treatment focuses on identifying cognitive distortions associated with MS; challenging cognitive distortions associated with the disease; and cognitive reconstruction of these beliefs, practicing to reduce attention to symptoms through attention distraction techniques, regulating sleep pattern, empowering patients to develop social activities by teaching communication skills and encouraging and supporting patients to increase mental activities such as reading or working with a computer.
Category
Behavior

3

Description
Control group: The group that receives only the usual drug treatment in MS patients and does not receive any other intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Iran MS Society
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

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran 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
Iran University of Medical Science
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
Academic

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
Imam Khomeini Boulevard, 31 Alley
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
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
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

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hani Rahimi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
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

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
Iran University of Medical Science
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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