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IRCT20250825066985N1 IRCT 2025-09-01 Islamic Azad University Effectiveness of compassion therapy based on mindfulness on reducing emotional failure symptoms and social adjustment of female students to love failure Effectiveness of compassion therapy based on mindfulness on reducing emotional failure symptoms and social adjustment of female students to love failure at Iranshahr University of Medical Sciences in 2024-2025 2025-08-19 anticipated 30 Complete https://irct.ir/trial/85742 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: 1. Randomization Method: Simple randomization was used. Participants were randomly assigned to either the intervention or control group. 2. Unit of Randomization: Individual; each participant was independently allocated to one of the two groups. 3. Stratified Randomization: No stratified randomization was applied in this study. 4. Randomization Tool: A random number table was used to perform the allocation. 5. Sequence Generation: The allocation sequence was generated by the second researcher using a random number table and stored as a coded list. 6. Allocation Concealment: Due to the nature of group-based psychotherapy, allocation concealment for participants and therapists was not feasible. However, the statistical analyst was blinded to group assignments. 2 Effectiveness of compassion therapy based on mindfulness on reducing emotional failure symptoms and social adjustment of female students to love failure at University of Medical Sciences. Intervention 1: Intervention group: Participants in the first intervention group attend eight in-person group sessions of compassion-focused therapy based on mindfulness. Sessions are held once a week, each lasting 90 minutes. The content includes mindfulness training, self-compassion exercises, emotional acceptance, reduction of rumination, and practical activities. The therapy is conducted by a trained clinical psychologist. Intervention 2: Control group: Participants in the control group do not receive any intervention and only take part in the pre-test and post-test assessments. Yes - There is a plan to make this available What will be shared: Individual participant data, full study protocol, statistical analysis plan, final clinical study report, analysis codes, and data dictionary will be shared. Participant data will be anonymized prior to sharing and will include scores related to the primary outcome variables (emotional failure and social adjustment), as well as basic demographic information. The informed consent form will not be published due to ethical considerations. When: Access will begin 6 months after the final study results are published. To whom: Study data and documents will be accessible to researchers affiliated with academic institutions, research centers, and scientific organizations. Individuals working in industry may also request access, provided they submit a clear and scientifically justified proposal. Access will be granted only after ethical review and approval. Conditions: Use of the data and documents is permitted solely for academic and research purposes. Applicants must submit a clear research proposal, including study objectives, intended analysis type (such as statistical analysis, meta-analysis, or result verification), and institutional affiliation. Use of the data for commercial, promotional, or non-scientific purposes is not allowed. Access will be granted only after review and ethical approval by the research team. Redistribution or publication of the data or documents without prior coordination with the research team is prohibited. Where to obtain: 1. Email: Fatemeh Firouzi Email: fatemeh77firouzi@gmail.com 2. Address: Iranshahr University of Medical Sciences Research Department, Psychology Division Islamic Azad University of Zahedan Research Deputy, Department of Psychology 3. Phone: Phone: 05437213891 For further information or coordination, initial contact via email is recommended. How to obtain: Applicants must submit a written request via email, clearly stating the research objective, intended type of analysis, institutional affiliation, and the specific data or documents required. Requests will be reviewed by the research team and, if necessary, ethical approval will be obtained. Upon approval, the requested data or documents will be shared electronically within 2 to 4 weeks from the receipt of a complete application. Redistribution or reuse of the data without prior coordination with the research team is not permitted. Comments:
public Fatemeh Firouzi
No. 24, End of Moallem Street, Shahr-e Deraz, Iranshahr County, Sistan and Baluchestan Province, Iran
Iranshahr Iran (Islamic Republic of) 9918645854 +98 901 375 9162 fatemeh77firouzi@gmail.com Islamic Azad University scientific Fatemeh Firouzi
No. 24, End of Moallem Street, Shahr-e Deraz, Iranshahr County, Sistan and Baluchestan Province, Iran
Iranshahr Iran (Islamic Republic of) 9918645854 +98 901 375 9162 fatemeh77firouzi@gmail.com Islamic Azad University Iran (Islamic Republic of) Absence of severe psychiatric or psychological disorders Ability to attend therapy sessions regularly High score on the emotional failure questionnaire Written informed consent to participate in the study Age between 18 and 30 years 18 years 30 years Female No experience of romantic breakup Age below 18 or above 30 years Not being a student at Iranshahr University of Medical Sciences being male Behavior N/A Intervention group: Participants in the first intervention group attend eight in-person group sessions of compassion-focused therapy based on mindfulness. Sessions are held once a week, each lasting 90 minutes. The content includes mindfulness training, self-compassion exercises, emotional acceptance, reduction of rumination, and practical activities. The therapy is conducted by a trained clinical psychologist. Control group: Participants in the control group do not receive any intervention and only take part in the pre-test and post-test assessments. Score on the emotional failure questionnaire before and after the intervention. Timepoint: Measured at baseline (before the intervention) and after completion of therapy sessions (week 8). Method of measurement: Emotional failure was measured using the Love Trauma Symptom Inventory developed by Ross in 1999. This instrument includes 10 items that assess physical, emotional, cognitive, and behavioral distress. Scoring is based on a five-point scale, and a score of 20 is considered the cutoff point. Score on the social adjustment questionnaire before and after the intervention. Timepoint: Measured at baseline (before the intervention) and after completion of therapy sessions (week 8). Method of measurement: Social adjustment was measured using the Social Adjustment Questionnaire developed by Sohrabi and Samani in 2011. This instrument consists of 15 items assessing five dimensions: personal, social, academic, occupational, and familial adjustment. Scoring is based on a five-point scale. Islamic Azad University Approved 2025-08-18 Ethics Committee of the Faculty of Medical Sciences, Islamic Azad University, Zahedan Branch Sistan and Baluchestan _ Iranshahr County _ Shahr Daraz, end of Moallem Street, K:24 Iranshahr Sistan-va-Balouchestan Iran (Islamic Republic of)