Protocol summary
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Study aim
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The aim of this study was to investigate the effect of social network-based cognitive-behavioral therapy intervention on the severity of PMS symptoms.
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Design
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Clinical trial with control group, with randomized parallel groups, without blinding, phase 3 on 140 patients
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Settings and conduct
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This randomized controlled trial study will be performed in comprehensive health centers affiliated to Guilan University of Medical Sciences, Rudbar city. The social media -based CBT program will be provided in 8 consecutive weeks within 14 separate sections of introductory, cognitive strategies, suggestions for behavioral lifestyle changes, and ends with relapse prevention. The Cognitive Strategies provides information and strategies for identifying and correcting dysfunctional cognitions, especially specific PMS cognitions and specific PMS behaviors and misconceptions. The other sections include suggestions for lifestyle changes such as stress reduction, exercise, and diet Cover a balanced diet. In the last section, a summary and a plan to protect the benefits and prevent returns is provided. All sections include practical exercises for applying and practicing theoretical content. Blinding will be done according to the nature of the study.
Control group will receive no intervention.
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Participants/Inclusion and exclusion criteria
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Willingness to participate in the study;
Age 45-20 years;
Moderate to severe premenstrual syndrome;
Internet access;
Having a smartphone
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Intervention groups
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The intervention group will receive social network-based cognitive-behavioral therapy for 8 consecutive weeks consisting of 14 separate sections including introductions, cognitive strategies, and suggestions for behavioral lifestyle changes and relapse prevention.
Control group will receive no intervention.
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Main outcome variables
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Severity of premenstrual syndrome symptoms
General information
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Reason for update
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Enter the actual date of start and end of sampling
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180218038789N4
Registration date:
2020-10-28, 1399/08/07
Registration timing:
prospective
Last update:
2023-06-10, 1402/03/20
Update count:
1
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Registration date
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2020-10-28, 1399/08/07
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-10-30, 1399/08/09
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Expected recruitment end date
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2021-05-20, 1400/02/30
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Actual recruitment start date
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2021-01-20, 1399/11/01
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Actual recruitment end date
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2021-08-30, 1400/06/08
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Trial completion date
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2021-08-30, 1400/06/08
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Scientific title
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Investigating the effect of social network-based cognitive-behavioral therapy intervention on the severity of PMS symptoms
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Public title
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Social network-based CBT for PMS
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Moderate to severe premenstrual syndrome
Internet access
having smart phone
Willingness to participate in the study
Exclusion criteria:
Diagnosis of psychosis or bipolar disorder
Diagnosis of eating disorder
Diagnosis of moderate to severe depression
Participate in psychotherapy for premenstrual symptoms now or in the past
Acute suicidal tendencies
Childbirth or breastfeeding during the last three months
Pregnancy
Gynecological diseases (hysterectomy, oophorectomy, cervical cancer, polycystic ovary syndrome, endometriosis, infertility)
Initiation or change in the use of antidepressants, benzodiazepines, antipsychotics, oral contraceptives or hormones over the past three months
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
140
Actual sample size reached:
140
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done by balanced blocking method with a block size of 4. The block randomization method is such that the allocation sequence is written before the start of the research. Given that the two groups will be studied, 4 blocks are used and each letter is assigned to a group (A: intervention group: B control group). All possible modes are written and numbered for a block of 4. Then, in a simple random method (using a table of random numbers), a number of numbers are selected from the block numbers and by writing the contents of the blocks related to those numbers (until the specified sample size is reached), The random assignment sequence is specified.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-30, 1399/07/09
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Ethics committee reference number
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IR.QUMS.REC.1399.252
Health conditions studied
1
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Description of health condition studied
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Premenstrual Syndrome
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ICD-10 code
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N94.3
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ICD-10 code description
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Premenstrual tension syndrome
Primary outcomes
1
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Description
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Severity of PMS symptoms
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Daily record of premenstrual syndrome symptoms
Secondary outcomes
1
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Description
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General self-efficacy
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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General self-efficacy questionnaire
2
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Description
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Professional QoL
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Professional QoL questionnaire
3
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Description
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The impact of premenstrual syndrome on daily life
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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PMS-Impact Questionnaire
4
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Description
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Coping with premenstrual symptoms
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Coping with premenstrual symptoms Scale
5
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Description
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Anxiety and Depression
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Hospital Anxiety and Depression Scale
6
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Description
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Fear of covid
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Timepoint
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Before the intervention, immediately and two months after the intervention
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Method of measurement
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Fear of Covid-19 scale
Intervention groups
1
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Description
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Intervention group: Cognitive-behavioral therapy based on social networks
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Category
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Behavior
2
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Description
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Control group: No intervention
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Qazvin University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The study-related files will be shared as supplementary articles after the end of the studies and at the time of publication of the results
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When the data will become available and for how long
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after the end of the studies and at the time of publication of the results
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To whom data/document is available
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All individuals
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Under which criteria data/document could be used
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In order to use the data for secondary data analysis or meta-analysis and by e-mail request to the responsible author
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From where data/document is obtainable
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Email to the person in charge
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What processes are involved for a request to access data/document
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Email to the person in charge
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Comments
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