Protocol summary

Study aim
Comparing the effectiveness of metacognitive therapy, acceptance and commitment therapy and Pilates exercise on emotional self-regulation, loneliness, dysfunctional attitudes and distress tolerance of women with premenstrual syndrome.
Design
Experimental research method, 80 people with premenstrual syndrome, available sampling method 4 groups in simple randomization with sealed envelopes, with unblinded parallel groups The experimental groups included metacognition, acceptance-commitment therapy and Pilates exercise Follow-up phase is two months later
Settings and conduct
In the Islamic Azad University in Doroud city in the form of group training of students to improve premenstrual syndrome. First, the subjects were pre-tested, then the interventions were performed on three groups, and the control group did not receive any intervention, then the post-test was performed by filling in the questionnaires, and a follow-up was performed after two months. Blinding is not done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of the syndrome of the sample based on the screening questionnaire (cut point 28 and above) Lack of medication for menstrual problems before the research Exclusion criteria: Taking psychiatric and psychoactive drugs and other therapies Suffering from psychiatric disorders based on the person's own report
Intervention groups
Acceptance and Commitment Therapy Metacognitive Therapy Pilates exercises control group
Main outcome variables
The most important outcome of this research is comparing the effectiveness of therapeutic interventions of acceptance and commitment, metacognition and Pilates exercises on dysfunctional attitudes, loneliness feelings, psychological distress and emotional self-regulation in women with premenstrual syndrome

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230123057194N1
Registration date: 2023-06-13, 1402/03/23
Registration timing: retrospective

Last update: 2023-06-13, 1402/03/23
Update count: 0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Azadeh Niroomand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4251 8000
Email address
az.niroomand@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-08, 1401/11/19
Expected recruitment end date
2023-02-14, 1401/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of metacognitive therapy, acceptance and commitment therapy and Pilates exercises on emotional self-regulation, loneliness feeling, dysfunctional attitudes, and distress tolerance in the women with premenstrual syndrome
Public title
The comparison of the effectiveness of metacognitive therapy, acceptance and commitment therapy and Pilates exercises in the women with premenstrual syndrome
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of the syndrome of the subjects based on the screening questionnaire (cut point 28 and above) Informed consent to participate in research Lack of medication for menstrual problems before the study No abuse of tobacco, drugs and cigarettes
Exclusion criteria:
Taking psychiatric and psychoactive drugs Absence of more than 2 sessions in treatment sessions Simultaneous participation in other courses and therapeutic interventions at the same time as research Drug abuse and smoking Having psychiatric disorders based on the person's self-report
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Available sampling method, simple randomization: each person was presented with 4 sealed envelopes in the number of groups (three experimental groups and one control), based on the choice of an envelope by the subject himself, his placement in a group is done. Individual unit
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 in Research of Islamic Azad University, Borujerd Branch
Street address
No 26, Moazami Alley, Golstan Blvd. Takhti St.
City
Borujerd
Province
Lorestan
Postal code
6915973863
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.IAU.B.REC.1401.009

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
Premenstrual syndrome cut point score is 28
Timepoint
pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session)
Method of measurement
Premenstrual Screening Questionnaire (PSST) Steiner et al. (2003)

Secondary outcomes

1

Description
the intervention should increase self-emotional regulation
Timepoint
pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session)
Method of measurement
Emotional self-regulation questionnaire (ERQ) Gross and John (2003)

2

Description
the intervention should decrease the loneliness feeling
Timepoint
pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session)
Method of measurement
Loneliness Scale-Third Edition (UCLA LS3) Russell (1996)

3

Description
the intervention should decrease the dysfunctional attitudes
Timepoint
pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session)
Method of measurement
Dysfunctional Attitudes Questionnaire (DAS) by Beck and Wiseman (1978)

4

Description
the intervention should increase the distress tolerance
Timepoint
pre-test (before the intervention), post-test (after the last intervention session), follow-up (two months after the last intervention session)
Method of measurement
Distress Tolerance Scale (DTS) Simmons and Gaher (2005)

Intervention groups

1

Description
The structure of the acceptance and commitment treatment protocol sessions, which is taken from the article by Hayes et al. (2016), is implemented in a group for eight weeks and a two-hour session every week for women with PMS.
Category
Other

2

Description
The structure of the sessions of metacognitive therapy protocol, which is taken from the article of Wells (2009), is implemented for ten weeks and a two-hour session every week for women with premenstrual syndrome.
Category
Other

3

Description
The structure of the Pilates exercise protocol session, which is taken from the research of Taghizadeh et al. (2020) and Ghorbanian and Mahmoodpoor (2019), is performed for eight weeks and three one-hour sessions every week for women with premenstrual syndrome as a group.
Category
Other

4

Description
Control group: without intervention
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Doroud Branch
Full name of responsible person
Azadeh Niroomand
Street address
No. 26, Moazami Alley, Golstan Blvd, Takhti St.
City
Borujerd
Province
Lorestan
Postal code
6915973863
Phone
+98 66 4253 0877
Email
az.niroomand@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Personal
Full name of responsible person
Azadeh Niroomand
Street address
Takhti St.
City
Borujerd
Province
Lorestan
Postal code
6915973863
Phone
+98 66 4253 0877
Email
az.niroomand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Personal
Proportion provided by this source
100
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
Islamic Azad University. Borujerd Branch
Full name of responsible person
Azadeh Niroomand
Position
Ph. D Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Nawab Square - Yadgar Imam St.
City
Borujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Fax
+98 66 4251 8013
Email
az.niroomand@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azadeh Niroomand
Position
PhD. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Navab Sq. Yadegare Emam Street
City
Borujerd
Province
Lorestan
Postal code
6915973863
Phone
+98 66 4251 8000
Fax
Email
az.niroomand@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azadeh Niroomand
Position
PhD. student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Navab Sq. Yadegare Emam Street
City
Borujerd
Province
Lorestan
Postal code
6915973863
Phone
+98 66 4251 8000
Fax
Email
az.niroomand@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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