Comparison of Therapist-Guided Versus Self-Guided Internet-Based Stress Inoculation Therapy (ISIT) on Psychological Distress Symptoms in Women After Miscarriage in Iran: A Study Protocol of a Randomized Clinical Trial.
TL;DR
The positive results of ISIT counseling on psychological distress symptoms and reducing perinatal grief during follow-ups conducted immediately post-intervention and 3 months after the intervention suggest that it will be useful for managing the complications of spontaneous abortion.
Abstract
Background and Aims Miscarriage can lead to various psychological consequences such as grief, anxiety, depression, and psychological distress. Although women who experience a miscarriage may not have formed a bond with their unborn child, the intensity of grief following an abortion does not significantly differ from the loss of other first-degree relatives. The present study will be conducted to compare therapist-guided versus self-guided internet-based stress inoculation therapy (ISIT) on psychological distress symptoms in women after miscarriage. Methods This study will be a randomized clinical trial with two parallel groups, conducted on 100 women with a history of miscarriage who are referred to prenatal clinics of educational hospitals affiliated with Babol University of Medical Sciences. Participants will be randomly assigned to two intervention groups. The first group will receive therapist-guided intervention (50 participants), consisting of 6 sessions of ISIT along with 20-25 min of weekly online counseling. The second group will receive a self-guided intervention (50 participants), consisting of only 6 sessions of ISIT without therapist guidance. The content of the SIT sessions includes techniques such as relaxation, cognitive restructuring, conceptualization, problem-solving, exercises, cognitive-behavioral methods, and stress coping. Data will be collected using demographic-reproductive characteristics questionnaires, brief symptom inventory-18 (BSI-18), and Perinatal Grief Scale at three time intervals: before the intervention, immediately after the intervention, and 3 months after the intervention. Data analysis will be performed using independent t-tests, Chi-square tests, and repeated measures analysis of variance with SPSS software version 23. Results It is expected that the study will yield anticipated outcomes in reducing psychological distress symptoms among women following a spontaneous abortion. It is also anticipated that counseling based on this model will reduce perinatal grief during follow-ups conducted immediately post-intervention and 3 months after the intervention concludes. Conclusion The positive results of ISIT counseling on psychological distress symptoms and reducing perinatal grief during follow-ups conducted immediately post-intervention and 3 months after the intervention suggest that it will be useful for managing the complications of spontaneous abortion. Trial Registration: This trial is prospectively registered on August 25, 2025, at the Iranian Registry of Clinical Trials (IRCT20230130057274N6).
