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IRCT20260721070287N1 IRCT 2026-10-18 Iran University of Medical Sciences Investigating the effect of group training based on schema therapy on hope and anxiety in women with infertility undergoing in vitro fertilization treatment IVF Investigating the effect of group training based on schema therapy on hope and anxiety in women with infertility undergoing in vitro fertilization treatment 2026-10-24 anticipated 36 Recruiting https://irct.ir/trial/91932 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Other design features: The present study is a controlled interventional (quasi-experimental) study designed to evaluate the effect of group schema therapy–based education on hope and anxiety among infertile women undergoing in vitro fertilization (IVF). Participants will be consecutively recruited from infertile women attending the Infertility Clinic of Shahid Akbarabadi Educational Hospital who meet the eligibility criteria. After providing written informed consent, participants will be randomly allocated to either the intervention or control group using a random numbers table.This clinic was selected as the study setting due to the accessibility of the target population and its willingness to collaborate with the research team. The sample size was calculated based on the estimated effect size reported in similar studies. Allowing for a minimum attrition rate of 10%, a total of 18 participants will be enrolled in each group.The educational intervention is based on Jeffrey Young's schema therapy approach, which was selected because of its emphasis on identifying and modifying early maladaptive schemas and their influence on cognitive, emotional, and behavioral patterns. The intervention will be delivered through structured educational sessions using cognitive, experiential, and behavioral techniques.The intervention will consist of twelve 90-minute sessions delivered both face-to-face and online. The educational content is based on the principles of schema therapy, adapted using evidence from studies conducted among infertile women, and supplemented with structured homework assignments. Participants in the control group will receive the routine care provided by the infertility center and, after completion of the study, will be provided with the schema therapy–based educational package.Outcome assessments will be performed at three time points: at baseline (before the intervention), immediately after completion of the twelfth intervention session, and four weeks after the end of the intervention. The primary outcome measures include hope, assessed using the Snyder Hope Scale, anxiety, assessed using the Beck Anxiety Inventory (BAI), and early maladaptive schemas, assessed using the Young Schema Questionnaire (YSQ).Data will be analyzed using SPSS software version 24. Between-group comparisons will be conducted using the independent-samples t-test, repeated-measures analysis, or analysis of covariance (ANCOVA), as appropriate. Potential confounding variables, including age, duration of infertility, cause of infertility (male or female factor), and type of infertility (primary or secondary), will be controlled for in the analyses. A two-sided p-value of less than 0.05 will be considered statistically significant, Randomization description: Participants who meet the inclusion criteria and are selected by the infertility specialist to undergo in vitro fertilization (IVF) after clinical evaluation will be randomly allocated to the intervention or control group using a random numbers table, following the provision of written informed consent. Sampling Method: Continuous Sampling will be conducted continuously. Participants will be assigned to either the intervention or control group using a table of random numbers. To this end, eligible individuals who have provided informed consent will be numbered from 1 to 18. From these, 18 numbers will be randomly selected and assigned to the intervention group, while the remaining 18 numbers will be assigned to the control group. N/A infertility. Intervention group: Schema therapy-based educational intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is The protocol stipulates that the confidential data remains with the principal investigator; it may only be released upon a formal request and with the university's authorization, and will not be published as public data.
public Fatemeh Mirzakhani Eshlaghi
Shahran 2nd Roundabout, Siadat Alley
Tehran Iran (Islamic Republic of) 1488874544 +98 21 4431 9831 fatemehmirzakhaniseptember@gmail.com Iran University of Medical Sciences scientific Fatemeh Mirzakhani Eshlaghi Mirzakhani Eshlaghi
Shahran
Tehran Iran (Islamic Republic of) 1488874544 +98 21 4473 8195 fatemehmirzakhaniseptember@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 1/Ability to read and write sufficiently to complete the study questionnaires.2/Confirmed diagnosis of infertility and selection for in vitro fertilization (IVF) by an infertility specialist.3/At least one year has elapsed since the diagnosis of infertility.4/ Age between 18 and 40 years.5/ No other physical or psychological disorders, based on self-report or documented medical records.6/No history of alcohol, illicit drug, or psychoactive substance use.7/Not currently using psychiatric medications.8/No experience of major stressful life events during the previous six months.9/No participation in infertility-related quality-of-life enhancement or psychological intervention programs during the previous six months.10/Undergoing the first IVF cycle. 18 years 40 years Female Failure to attend at least two educational intervention sessions.a. Diagnosis of or development of a medical illness during the intervention period.b. Occurrence of major stressful events or unexpected acute life events (e.g., the death of a close family member) at any stage of the study, as determined by participants' self-report. N/A Intervention group: Schema therapy-based educational intervention Mean hope score on the Snyder scale, mean anxiety score on the Beck inventory, and mean schema score on the Young questionnaire. Timepoint: Before and immediately after the completion of 12 sessions, and 4 weeks after the intervention ended. Method of measurement: Young's Schema Questionnaire, Schneider's Hope Questionnaire, and Beck's Anxiety Questionnaire. Iran University of Medical Sciences Approved 2026-08-31 Ethics Committee of Iran University of Medical Sciences Shahran 2nd Roundabout, Siadat Alley Tehran Tehran Iran (Islamic Republic of)