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Effectiveness of unified protocol of transdiagnostic treatment on psychological symptoms, fatigue, emotion regulation, health anxiety, sleep quality, and sexual satisfaction in patients with multiple sclerosis

Protocol summary

Study aim
Present study aims to investigate the effectiveness of unified protocol of transdiagnostic treatment (UP) on psychological symptoms, fatigue, emotion regulation, health anxiety, sleep quality, and sexual satisfaction in patients with multiple sclerosis (MS).
Design
This randomized and single-blind clinical trial with parallel and control groups will be conducted on 48 patients who will be randomly selected using the simple random.
Settings and conduct
Patients referring to Moheb Mehr Hospital Neurology Clinic, Tehran, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment and control group will not receive the treatment intervention. The responsible for data collection is blind to group allocation and the type of intervention.
Participants/Inclusion and exclusion criteria
Statistical society of the study includes all of the MS patients in Tehran, and selected sample will be 48 patients referred to neurology clinic of Moheb Mehr Hospital. Main inclusion criteria include confirmation of diagnosis of MS, being at least 20 y/o, being sexually active, fixed dosage of medicine since 3 month before the beginning of treatment, and not having severe psychiatric and physical illnesses.
Intervention groups
Intervention group will receive 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment and control group will not receive the treatment intervention.
Main outcome variables
Improving psychological symptoms (depression, anxiety, stress), fatigue, emotion regulation, health anxiety, sleep quality, and sexual satisfaction in MS patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221230056986N1
Registration date: 2023-06-17, 1402/03/27
Registration timing: prospective

Last update: 2023-06-17, 1402/03/27
Update count: 0
Registration date
2023-06-17, 1402/03/27
Registrant information
Name
Amir Mahdi Katani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
katani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of unified protocol of transdiagnostic treatment on psychological symptoms, fatigue, emotion regulation, health anxiety, sleep quality, and sexual satisfaction in patients with multiple sclerosis
Public title
Effectiveness of transdiagnostic treatment on psychological parameters in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of relapsing-remitting multiple sclerosis diagnosis by neurologist Age least 20 years Being sexually active Mastery in Persian language and reading and writing literacy Fixed dosage of medicine from 3 months before beginning the treatment Being physically able to participate in weekly sessions Not being diagnosed with severe psychiatric disorders Not being diagnosed with another serious or chronic physical illness Not having the history of receiving psychological treatments
Exclusion criteria:
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
The process of random allocation of study participants to two groups; intervention group and control group included both creating a random sequence and concealing the random allocation. Firstly, using the random sequence rule, 48 papers for participants of the intervention and control groups (which are marked with A and B and are not defined to avoid bias) were thrown into a lottery container and then the papers were removed from the lottery container -without replacement- and the created sequence is recorded Then, using the snooze method, 48 envelopes were prepared and each of the random sequences created is recorded on a card and placed in the envelopes in order, and the envelopes were also numbered. Then, the envelopes were given to the participants based on the order of entering the study, so the grouping of each was determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients referring to Moheb Mehr Hospital Neurology Clinic, Tehran, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment and control group will not receive the treatment intervention. The responsible for data collection is blind to group allocation and the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.MSP.REC.1398.669

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 symptoms
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Depression, Anxiety, Stress Scale (DASS-21)

2

Description
Fatigue
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Fatigue Severity Scale (FSS)

3

Description
Quality of sleep
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

4

Description
Sexual Satisfaction
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Larson Sexual Satisfaction Questionnaire (LSSQ)

5

Description
Emotion regulation
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Cognitive Emotion Regulation Questionnaire (SERQ)

6

Description
Health anxiety
Timepoint
Before intervention, after intervention, three month after intervention
Method of measurement
Health Anxiety Questionnaire (HAQ)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 12 sessions of online psychotherapy based on unified protocol of transdiagnostic treatment
Category
Treatment - Other

2

Description
Control group: Not receiving treatment intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Moheb Mehr Hospital Neurology Clinic
Full name of responsible person
Reza Hajmanouchehri
Street address
Khalilzadeh alley, after Vanak square, Valiasr St.
City
تهران
Province
Tehran
Postal code
1319919697
Phone
+98 21 85555
Email
info@moheb.com
Web page address
https://www.moheb.com/mohebmehr/home/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Web page address
https://research.sbmu.ac.ir/index.jsp?pageid=2554&p=1
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mahdi Katani
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 11, west Eram alley, south Bahar St, west Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
1484647366
Phone
+98 21 4411 6678
Email
amir.katani.1993@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mahdi Katani
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 11, west Eram alley, south Bahar St, west Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
1484647366
Phone
+98 21 4411 6678
Email
amir.katani.1993@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mahdi Katani
Position
Phd Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No 11, west Eram alley, south Bahar St, west Ferdows Blvd.
City
Tehran
Province
Tehran
Postal code
1484647366
Phone
+98 21 4411 6678
Email
amir.katani.1993@gmail.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
SPSS file of participants data, treatment protocol of study, and informed consent form will be available if necessary.
When the data will become available and for how long
After execution of study
To whom data/document is available
Editor in chief of scientific journals
Under which criteria data/document could be used
At request of editor in chief of scientific journals
From where data/document is obtainable
By email: amir.katani.1993@gmail.com
What processes are involved for a request to access data/document
Data will be sent by email after request.
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