The Efficacy of Unified Trans diagnostic Treatment on Cognitive Mechanisms of Emotion Regulation, Sleep Disorder and Symptoms Remission of Premenstrual Syndrome (PMS)
The aim of present study is the Efficacy of Unified Trans diagnostic Treatment on Cognitive Mechanisms of Emotion Regulation, Sleep Disorder and Symptoms Remission of Premenstrual Syndrome (PMS).
Design
A randomized, double -blind, with parallel groups clinical trial. 40 patients with Premenstrual symptoms in two groups (20 people) of experimental and control are assigned randomly.
Settings and conduct
Location is Taleghani hospital.40 patients are selected. 20 patients in experimental group and 20 patients in control group are assigned randomly. In this double-blind study, the psychiatrist and data analyzer were kept blind to the treatment. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of premenstrual syndrome based on diagnostic and Statistical Manual of Mental Disorders (DSM), Lack of mental retardation, No use of psychiatric drugs before the study.
Exclusion criteria:Dissatisfaction to participate in study, Psychiatric comorbidity, Drug allergy.
Intervention groups
Intervention group:The first group was treated with Unified Trans diagnostic Treatment: The first group participates in Unified Trans diagnostic Treatment session for 8 weeks (One session per week).
Control group: The control group does not receive any treatment.
Main outcome variables
Symptoms of Premenstrual, Quality of sleep, Cognitive emotion regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049518N1
Registration date:2020-12-05, 1399/09/15
Registration timing:prospective
Last update:2020-12-05, 1399/09/15
Update count:0
Registration date
2020-12-05, 1399/09/15
Registrant information
Name
Nazanin Ahangari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7717 4767
Email address
drahangari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-04, 1399/10/15
Expected recruitment end date
2021-02-03, 1399/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Unified Trans diagnostic Treatment on Cognitive Mechanisms of Emotion Regulation, Sleep Disorder and Symptoms Remission of Premenstrual Syndrome (PMS)
Public title
Unified Trans diagnostic Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of premenstrual syndrome based on diagnostic and Statistical Manual of Mental Disorders (DSM)
Lack of mental retardation
No use of psychiatric drugs before the study
Exclusion criteria:
Dissatisfaction to participate in study
Psychiatric comorbidity
Drug allergy
Age
From 17 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is a simple randomization method. The unit of randomization is individual. Using the table of random numbers, patients are randomly divided into two groups: experimental and control. Even numbers are considered for the experimental group and odd numbers are for the control group. Random allocation is done by the researcher and the clinical caregiver and data analyzer are not aware of the allocation of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatment allocation was concealed from the psychiatrist and the data analyzer who rated patients by using successively numbered, opaque, and sealed envelopes. In fact, participants pick up envelopes inside the box randomly which are in an unspecified wrapper. They are aware which experimental group they were assigned to.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Taleghani hospital, Yemen street, Shahid Chamran road, Shahid Beheshti University of Medical Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.SBMU.MSP.REC.1398.668
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Symptoms of Premenstrual
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group premenstrual symptoms are evaluated.
Method of measurement
Premenstrual Syndrome Screening (PSST)
2
Description
Quality of sleep
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group quality of sleep is evaluated.
Method of measurement
Iowa Sleep Disturbances Inventory (ISDI)
3
Description
تنظیم شناختی هیجان
Timepoint
At the first of study (before the intervention), 4 and 8 week after starting psychotherapy sessions in experimental and control group cognitive emotion regulation is evaluated.
Method of measurement
Cognitive Emotion Regulation Questionnaire (CERQ)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The first group was treated with Unified Trans diagnostic Treatment: The first group participates in Unified Trans diagnostic Treatment session for 8 weeks (One session per week).
Category
Treatment - Other
2
Description
Control group: The control group does not receive any treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Nazanin Ahangari
Street address
Taleghani hospital, Yemen street, Shahid Chamran high way, Shahid Beheshti University of Medical Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
drahangari@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
ایران، تهران، دانشگاه علوم پزشکی شهید بهشتی، بزرگراه شهید چمران، خیابان یمن، بیمارستان طالقانی
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9331
Email
zarghi@sbmu.ac.ir
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
Khoram-Abad University of Medical Sciences
Full name of responsible person
Saba Hasanvandi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Lorestan University of Medical Sciences, Kilometer 5 Road of Tehran-Khorram Abad, Khorram Abad, Lorestan, Iran.
City
Khorram Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3324 2643
Email
s.hasanvandi@alzahra.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Ahangari
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Taleghani hospital, Yemen street, Shahid Chamran road, Shahid Beheshti University of Medical Science, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
drahangari@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nazanin Ahangari
Position
phd
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahid Beheshti University of Medical Sciences, Yemen street, Shahid Chamran high way, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
drahangari@sbmu.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only part of the data, such as information related to main outcome or like that , can be share.
When the data will become available and for how long
Start of access, 6 months after publishing the results
To whom data/document is available
Only people working in academic institutions could apply.
Under which criteria data/document could be used
People who are conducting clinical trials in this field could apply.
From where data/document is obtainable
By referring to the electronic address: drahangari@sbmu.ac.ir
What processes are involved for a request to access data/document
The applicant can receive information by registering the exact personal details.