Determining the effectiveness of stress inoculation training approach on anxiety and depression of students with premenstrual syndrome
Design
Randomized controlled clinical trial
Settings and conduct
Dormitory students of Babol University of Medical Sciences are selected as available, then they are given a 14-question anxiety/depression questionnaire. Any person who has a score of 8 or higher in one of the following components, i.e. depression or anxiety, will enter the study with the diagnosis of depression/anxiety symptoms. Students who meet the study entry criteria are randomly assigned to two intervention and control groups. Then, all of them are given questionnaires 5 days before menstruation and maximum in the first 2 days of menstruation, and students with moderate and high PMS are included in the study based on the PSST questionnaire.
Participants/Inclusion and exclusion criteria
Inclusion criteria: students with premenstrual syndrome. Exclusion criteria: students without premenstrual syndrome.
Intervention groups
Recipient of six training sessions on the stress inoculation approach
Main outcome variables
Change in anxiety and depression scores
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230130057274N2
Registration date:2023-12-31, 1402/10/10
Registration timing:retrospective
Last update:2023-12-31, 1402/10/10
Update count:0
Registration date
2023-12-31, 1402/10/10
Registrant information
Name
Hajar Adib-Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9592
Email address
adibrad2015@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-30, 1401/08/08
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
2022-10-30, 1401/08/08
Actual recruitment end date
2023-06-21, 1402/03/31
Trial completion date
2023-06-21, 1402/03/31
Scientific title
Effectiveness of stress inoculation training (SIT) counseling approach on anxiety, and depression of students with premenstrual syndrome
Public title
Effectiveness of stress inoculation training approach on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being Iranian
Students living in the student dormitory of Babol University of Medical Sciences
Declaration of consent to participate in the study
Having premenstrual syndrome
Having regular menstrual cycles with intervals of 21 to 35 days and a duration of 3 to 7 days at least during the last six months
Having 5 symptoms of premenstrual syndrome for two consecutive months
Having symptoms of depression or anxiety with a score of 8 or higher
Access to the smartphone
Age range from 18 to 38 years
Exclusion criteria:
Use of antidepressants and anxiety medications during the study
Participation in other psychological interventions such as psychotherapy, meditation, yoga
Occurrence of stressful events at least six months before the start of the study
Suffering from genital diseases and known and chronic underlying diseases
Taking birth control pills
Hormonal disorders and irregular menstruation
Current or history of severe mental illness such as severe depression, bipolar disorder, and suicidal thoughts
Drug addiction and consumption of psychoactive substances or alcohol
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are randomly divided into two groups after applying the inclusion and exclusion criteria in the form of random allocation using the alternative block method. The size of the blocks is 4 and using the statistical software, 4 blocks will be produced 25 times. Considering that the sampling is done in one center, a sample list of 100 items will be produced. Using this randomly generated list, the participants are assigned to two groups of 50 people. The random sequence of people in the intervention or control groups is done through block building with a ratio of 1:1, and the researcher cannot predict the placement of the next person in any of the two 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
Health Research Institute - Babol University of Medical Sciences (Research Ethics Committee)
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
47176-47745
Approval date
2022-10-30, 1401/08/08
Ethics committee reference number
IR.MUBABOL.HRI.REC.1401.156
Health conditions studied
1
Description of health condition studied
Anxiety and depression
ICD-10 code
F41.2
ICD-10 code description
Mixed anxiety and depressive disorder
Primary outcomes
1
Description
Anxiety
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Hospital anxiety and depression questionnaire
2
Description
Depression
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Hospital anxiety and depression questionnaire
Secondary outcomes
1
Description
Stress
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Perceived Stress Questionnaire 14
2
Description
Performance
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Sheehan's Disability Questionnaire
3
Description
Psychological well-being
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Riff's Psychological Well-Being Questionnaire
4
Description
Symptoms of premenstrual syndrome
Timepoint
Before the intervention, immediately after the end of the intervention in the luteal phase, the first and second menstrual cycle after the intervention
Method of measurement
Premenstrual Symptoms Screening Questionnaire
Intervention groups
1
Description
Intervention group: In the intervention group, SIT therapy method is performed individually, which includes 6 consecutive sessions (one session per week) and the duration of each session is 30-45 minutes. The content of the meetings includes:The first session: Conceptualization of the therapeutic model, gaining awareness about the relationship between premenstrual syndrome and negative emotions, acquiring the skills to identify and evaluate thoughts and feelings, relaxation techniquesThe second session: acquiring the ability to identify negative automatic thoughts and begin to change them, relaxation techniquesThe third session: acquiring the ability to recognize cognitive errors, relaxation techniquesThe fourth session: acquiring the skill of correcting auto-negative thoughts, calming techniques The fifth session: acquiring the ability to evaluate daily activities, stress coping techniques, relaxation techniquesThe sixth session: developing effective coping plans for stress, challenges of ending treatment, complete relaxation techniques
Category
Treatment - Other
2
Description
Control group: This group of students does not receive SIT treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences dormitories
Full name of responsible person
Mahbobeh Faramarzi
Street address
School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9595
Fax
Email
mahbob330@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mehdi Rajab Nia
Street address
Vice-Chancellor's Office for Research, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 4720
Email
ramazan69@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hajar Adib-Rad
Position
Faculty member - Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
Department of Midwifery, School of Medicine, Babol University of Medical Sciences, Ganj Afrooz St., Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 0597
Email
Adibrad2015@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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