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IRCT20251118068037N1 IRCT 2026-01-03 Kashan University of Medical Sciences “Examining the Effectiveness of a Group-Based Psychological Intervention in Reducing Psychological Distress and Stress, Improving Emotion Regulation, and Enhancing Coping with Illness-Related Uncertainty in Women with Breast Cancer” The effect of Unified Protocol transdiagnostic treatment on psychological distress, emotion regulation, intolerance of uncertainty, and posttraumatic growth in women with breast cancer. 2026-02-14 anticipated 50 Complete https://irct.ir/trial/88321 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: Matched Randomization. Randomization Unit: Individual. Stratification Layers: Participants are matched into pairs based on disease stage and initial severity of psychological distress. Randomization Tool and Sequence Generation: After forming matched pairs, one member is randomly assigned to the intervention group and the other to the control group using the website www.randomizer.org for each pair. Allocation Concealment: The use of this online tool ensures unbiased allocation and proper allocation concealment, Blinding description: Due to the nature of the intervention, which is group psychotherapy, blinding of the participants and the principal investigator (who also acts as the therapist) is not feasible; participants are aware of receiving or not receiving the treatment, and the therapist must deliver the protocol. However, to adhere to scientific standards and minimize bias, the study is designed as single-blind. In this regard, the Data Analyst, who is responsible for examining the results and testing the hypotheses, is kept completely blinded to the group allocation. The raw data are coded (e.g., Group A and Group B) and provided to the analyst without labeling them as intervention or control, ensuring that the final analysis is conducted without prejudice. 3 Breast cancer. Intervention 1: Intervention group: Intervention group: Participants in this group will receive group therapy based on the “Unified Protocol for Transdiagnostic Treatment of Emotional Disorders” (UP), following the manual by David Barlow et al. The intervention consists of 8 weekly sessions (each lasting 90 minutes). The session content includes: Session 1: Motivation for change and treatment engagement (analyzing pros and cons, goal setting).Session 2: Understanding emotions and introduction to Emotion-Driven Behaviors (EDBs).Session 3: Emotional awareness training (non-judgmental observation of experiences and present-moment attention).Session 4: Cognitive reappraisal and enhancing cognitive flexibility. Session 5: Identifying and modifying emotional avoidance patterns and EDBs. Session 6: Increasing tolerance of physical sensations (interoceptive exposure).Session 7: Exposure to emotional situations and feelings (creating hierarchies and conducting exposure).Session 8: Maintaining treatment gains and relapse prevention. Intervention 2: Control group: Control group: Participants in this group will not receive any psychological intervention during the study period and are placed on a waiting list. They will only receive standard medical Treatment as Usual (TAU) related to their condition. Depending on the specialist physician’s prescription, these treatments include chemotherapy, radiotherapy, or surgery (mastectomy). Yes - There is a plan to make this available What will be shared: De-identified Individual Participant Data (IPD) will be shareable. These data include the main outcome variables of the study (scores from questionnaires on psychological distress, emotion regulation, intolerance of uncertainty, and posttraumatic growth) and baseline demographic variables. When: Access starts 6 months after the publication of the results To whom: Data will be available only to researchers working in academic and scientific institutions who intend to conduct secondary analysis or meta-analysis. Conditions: Applicants must provide their research proposal. Data use is permitted solely for the scientific purposes stated in the applicant’s proposal. Citation of the original article resulting from this research is mandatory in the publication of results. Where to obtain: Applicants can send their request to the corresponding author’s email address ([javadghafooriii@gmail.com]). They can also correspond with the Vice Chancellor for Research and Technology at Kashan University of Medical Sciences. How to obtain: The applicant sends a written request along with the research proposal to the corresponding author’s email. The request will be reviewed by the research team, and upon scientific and ethical approval, the data will be sent to the applicant as an encrypted file within 1 month. Comments:
public Mohammad Javad Ghafoori
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5510 9999 javadghafooriii@gmail.com Kashan University of Medical Sciences scientific Hamid Amiri
Pezeshk Blvd., Qotb Ravandi Blvd., Kashan
Kashan Iran (Islamic Republic of) 8715973474 +98 31 5510 9999 amiri.kaums@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Female gender Age range of 18–55 years A definitive diagnosis of breast cancer confirmed by an oncologist Obtaining a moderate score on the Depression Anxiety Stress Scales (DASS-21) according to the questionnaire guidelines (scores of 14–20 for Depression, 10–14 for Anxiety, and 19–25 for Stress) Literacy (reading and writing skills) and the ability to comprehend the concepts presented in the therapy sessions Willingness to participate voluntarily in the study and signing the informed consent form Ability to attend regular group therapy sessions during the 8-week intervention period History of receiving at least one course of chemotherapy, radiotherapy, or mastectomy 18 years 55 years Female Emergence of acute psychiatric symptoms such as suicidal ideation, psychotic disorders, or severe emotional instability that render the continuation of group therapy impossible Receiving concurrent psychological interventions (such as other individual or group therapies) during the study period Initiation of new psychiatric medications or significant changes in the dosage of current medications during the treatment period C50-C50 Malignant neoplasm of breast Rehabilitation Treatment - Other Intervention group: Intervention group: Participants in this group will receive group therapy based on the “Unified Protocol for Transdiagnostic Treatment of Emotional Disorders” (UP), following the manual by David Barlow et al. The intervention consists of 8 weekly sessions (each lasting 90 minutes). The session content includes: Session 1: Motivation for change and treatment engagement (analyzing pros and cons, goal setting).Session 2: Understanding emotions and introduction to Emotion-Driven Behaviors (EDBs).Session 3: Emotional awareness training (non-judgmental observation of experiences and present-moment attention).Session 4: Cognitive reappraisal and enhancing cognitive flexibility. Session 5: Identifying and modifying emotional avoidance patterns and EDBs. Session 6: Increasing tolerance of physical sensations (interoceptive exposure).Session 7: Exposure to emotional situations and feelings (creating hierarchies and conducting exposure).Session 8: Maintaining treatment gains and relapse prevention. Control group: Control group: Participants in this group will not receive any psychological intervention during the study period and are placed on a waiting list. They will only receive standard medical Treatment as Usual (TAU) related to their condition. Depending on the specialist physician’s prescription, these treatments include chemotherapy, radiotherapy, or surgery (mastectomy). Primary Outcome 1: The total score obtained by participants on the Psychological Distress Scale (DASS-21) at the post-test and follow-up stages.Primary Outcome 2: The total score obtained by participants on the Posttraumatic Growth Inventory (PTGI) at the post-test and follow-up stages.Secondary Outcome 1: The total score obtained by participants on the Difficulties in Emotion Regulation Scale (DERS) at the post-test and follow-up stages.Secondary Outcome 2: The total score obtained by participants on the Intolerance of Uncertainty Scale (IUS) at the post-test and follow-up stages. Timepoint: The measurement time points for all primary and secondary outcome variables in this study are identical and will be conducted at three stages as follows:Before the start of the first therapeutic intervention session (Baseline / Pre-test)Immediately after the completion of the final (eighth) therapy session (Post-test)Two months after the completion of the therapeutic intervention (Follow-up). Method of measurement: Primary Outcome 1 (Psychological Distress): Measurement will be conducted using the 21-item version of the Depression, Anxiety and Stress Scale.Primary Outcome 2 (Posttraumatic Growth): Measurement will be conducted using the Posttraumatic Growth Inventory, designed by Tedeschi and Calhoun (1996).Secondary Outcome 1 (Emotion Regulation): Measurement will be conducted using the Difficulties in Emotion Regulation Scale, developed by Gratz and Roemer (2004).Secondary Outcome 2 (Intolerance of Uncertainty): Measurement will be conducted using the Intolerance of Uncertainty Scale, developed by Freeston et al. (1994). Secondary OutcomesSecondary Outcome 1: The total score obtained by participants on the Difficulties in Emotion Regulation Scale (DERS) at the post-test and follow-up stages.Secondary Outcome 2: The total score obtained by participants on the Intolerance of Uncertainty Scale (IUS) at the post-test and follow-up stages. Timepoint: The measurement time points for all primary and secondary outcome variables in this study are identical and will be conducted at three stages as follows:Before the start of the first therapeutic intervention session (Baseline / Pre-test)Immediately after the completion of the final (eighth) therapy session (Post-test)Two months after the completion of the therapeutic intervention (Follow-up). Method of measurement: Secondary Outcome 1 (Emotion Regulation): Measurement will be conducted using the Difficulties in Emotion Regulation Scale, developed by Gratz and Roemer (2004).Secondary Outcome 2 (Intolerance of Uncertainty): Measurement will be conducted using the Intolerance of Uncertainty Scale, developed by Freeston et al. (1994). Kashan University of Medical Sciences Approved 2025-12-21 Research Ethics Committee, Faculty of Medicine and Dentistry, Kashan University of Medical Sciences Pezeshk Blvd., Qotb Ravandi Blvd., Kashan Kashan Isfehan Iran (Islamic Republic of)