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.
Sep 2026· Health Science Reports· Vol 9 9, pp.
e72846
· 0 citations
Medicine
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).
Background: Schema therapy has been proposed as an integrative intervention that targets both emotional symptoms and maladaptive behavioral patterns; however, empirical evidence of its effectiveness for these outcomes remains limited. Objectives: This study aimed to evaluate the effectiveness of a schema therapy-based intervention in reducing psychological distress and self-defeating behaviors among women with dependent personality traits. Methods: This quasi-experimental study used a pretest–posttest design with a control group. The study population comprised women with dependent personality traits who were referred to psychological counseling centers in Rasht, Iran. A total of 34 participants were recruited through convenience sampling and assigned to an intervention group (n = 17) or a control group (n = 17). The intervention group received 8 sessions of group-based schema therapy based on the mode model, whereas the control group received no intervention. Psychological distress was assessed using the Kessler Psychological Distress Scale (K10), and self-defeating behaviors were measured using a self-report questionnaire. Data were analyzed using independent-samples t tests and effect sizes (Cohen d) in SPSS version 26. Results: The results showed significant reductions in psychological distress and self-defeating behaviors in the intervention group compared with the control group at posttest (P < 0.05). Large effect sizes were observed for both psychological distress and the total self-defeating behavior score, indicating clinically meaningful improvement. Conclusions: Schema therapy appears to be an effective intervention for reducing psychological distress and self-defeating behaviors among women with dependent personality traits. These findings support the use of schema-based interventions in mental health settings.
Roghayeh Tezval, Tahereh Hamzehpoor Haghighi, Z. Mirpour· Journal of Health Reports an...· 0 citations
Abstract Background Depressive disorders are a leading cause of disability among women worldwide, yet existing interventions often fail to account for the biological and sociocultural factors shaping women’s risk and symptom presentation. Objective In response, this randomized, single-blind, controlled trial will evaluate the efficacy of the 3D Program—a gender-sensitive, guided internet-based cognitive behavioral therapy (iCBT) intervention for women with moderate depressive symptoms. Methods A total of 120 women presenting with moderate depressive symptoms (17-item Hamilton Depression Rating Scale score 17‐23), aged 18 to 45 years, will be randomized to receive either the 10-week 3D Program or informational video content, with both groups continuing treatment as usual. The 3D Program will integrate personalized therapist support, self-guided digital modules, and a moderated online group, with content cocreated alongside women with lived experience of depressive symptoms. The primary outcome will be the change in depressive symptom severity, measured by the 17-item Hamilton Depression Rating Scale at 12- and 26-week postbaseline assessments. Secondary outcomes will include functioning, quality of life, perceived stress, and menstrual-related distress. Additionally, the study will explore potential biological predictors of treatment response, analyzing metabolic markers related to tryptophan metabolism and adrenal steroid pathways across multiple biological matrices. Data analyses will use linear mixed-effects models and multivariate techniques to examine treatment effects and possible biomarker associations. Results The trial was funded in October 2023 (grant PI23/00257, Spanish Ministry of Economy and Competitiveness), and ethical approval was obtained in February 2024. The trial was registered in July 2025 (ClinicalTrials.gov NCT07060690). Data collection began in March 2026 and is projected to conclude in August 2027. As of April 2026, a total of 8 participants have been enrolled. Data analysis has not yet commenced. The results are expected to be published in the summer of 2028. Conclusions This trial aims to address critical gaps in accessible, personalized, and gender-sensitive mental health care. If effective, the 3D Program may serve as a scalable, cost-efficient adjunct to routine care for women with depressive symptoms in public health systems, while biomarker findings may lay the groundwork for future trials examining predictors of response.
N. Angarita-Osorio, A. García-Estela, L. Terraneo et al.· JMIR Research Protocols· 0 citations
Purpose: This study aimed to compare the effectiveness of Intensive Short-Term Dynamic Psychotherapy (ISTDP) and Acceptance and Commitment Therapy (ACT) on reducing psychological distress and enhancing ego strength in women victims of domestic violence. Methods and Materials: This quasi-experimental study employed a pretest-posttest-follow-up design with a control group. Forty-five women aged 20 to 45 who had experienced domestic violence and met the inclusion criteria were selected purposefully from counseling centers in Gorgan, Iran, and randomly assigned into three groups: ISTDP (n = 15), ACT (n = 15), and control (n = 15). Participants completed the Depression Anxiety Stress Scales (DASS-21) and the Ego Strength Scale (ESS) before and after the interventions and again at a three-month follow-up. The ISTDP intervention was administered in 15 individual sessions, and the ACT protocol was delivered in 8 individual sessions. The control group was placed on a waitlist. Data were analyzed using repeated measures multivariate analysis of variance (MANOVA) and Bonferroni post hoc tests. Findings: The results indicated significant effects of time on psychological distress variables including depression (F = 102.07, P < .001), anxiety (F = 33.70, P < .001), and stress (F = 72.75, P < .001), and on ego strength dimensions such as ego control (F = 48.57, P < .001), resilience (F = 18.59, P < .001), mature defenses (F = 79.95, P < .001), problem-focused coping (F = 28.23, P < .001), and emotion-focused coping (F = 30.55, P < .001). However, no significant differences were found between the ISTDP and ACT groups (P > .05) in any of the outcome variables. Conclusion: Both ISTDP and ACT were equally effective in significantly reducing psychological distress and improving ego strength in women victims of domestic violence, and their benefits were sustained at follow-up. These findings support the use of either therapy in trauma-focused clinical interventions.
Sahar Shokohifar, Hossein Mahdian, M. Motlagh· The Iranian Journal of Neuro...· 0 citations
Introduction: Infertility is a major public health challenge that affects a significant portion of the global population. This condition not only has significant physiological consequences, but also has widespread psychological effects such as anxiety, depression, internalized shame, and mood swings, especially in infertile women. Research has shown that women who undergo hormone therapy for infertility often experience significant psychological problems such as anxiety, depression, and irritability. According to recent studies (González-Rodríguez et al., 2020; Rooney & Domar, 2018), these effects may be due to hormonal changes and psychosocial stressors that create new challenges for these women. This study aimed to investigate the effectiveness of integrated acceptance and commitment therapy (ACT-CFT) on reducing internalized shame and psychological complications caused by hormone therapy in infertile women. Methods: This study was a quasi-experimental study with a pre-test-post-test design with a control group. The statistical population included infertile women in Isfahan in 1402 who were undergoing hormone therapy. Among these individuals, 32 people were purposefully selected and randomly assigned to two experimental and control groups (16 people in each group). The research tools included the Cook Internalized Shame Questionnaire (1993) and a semi-structured interview with infertile women. The experimental group received 10 90-minute sessions of integrated therapy intervention (ACT-CFT) as a group. Meanwhile, the control group did not receive any intervention. After the sessions, the data were analyzed using analysis of covariance (ANCOVA) and SPSS software. Findings: The results of data analysis showed that the combined treatment (ACT-CFT) significantly reduced internalized shame (P < 0.05) and improved psychological complications caused by hormone therapy in infertile women in the experimental group compared to the control group. The mean scores of internalized shame in the experimental group decreased significantly after the intervention. These changes were striking compared to the control group, which experienced only a slight decrease and natural fluctuations caused by the discontinuation of hormone therapy. Conclusion: This study shows that the combined intervention of acceptance and commitment based on compassion (ACT-CFT) can be used as an effective treatment method to reduce internalized shame and improve psychological complications caused by hormone therapy in infertile women. It is suggested that this intervention be included as a complementary treatment along with other infertility treatment methods.
Sanaz Pourgoli, Maryam Dehghan, Kamran Pourmohammad Ghouchani et al.· Health Psychology and Behavi...· 0 citations
The aim of the present study was to examine and compare the effectiveness of Compassion-Focused Therapy (CFT) and Mindfulness-Based Cognitive Therapy (MBCT) on self-esteem in female breadwinner mothers. This applied study employed an experimental method with a pretest–posttest design and a three-month follow-up, including a control group. The statistical population consisted of female breadwinner mothers residing in District 14 of Tehran, from whom 45 individuals were selected through convenience sampling and randomly assigned to three groups of 15 participants (two experimental groups and one control group). The experimental groups received eight weekly 90-minute treatment sessions. Data were collected using the Rosenberg Self-Esteem Scale and analyzed through repeated-measures analysis of variance. The results indicated that both interventions were effective in improving the variables under investigation. Based on the findings, it can be concluded that psychological interventions grounded in compassion and mindfulness can be utilized as effective approaches for enhancing the mental health of female breadwinner mothers. Therefore, employing these approaches in supportive and counseling programs aimed at empowering this segment of society is recommended.
Shiva Parsamanesh, Reza Khakpour, Rahim Davari· Mental Health and Lifestyle...· 0 citations
Introduction and Aim: Infertile women face many problems in their married life, and may disrupt their emotional self-regulation and increase the likelihood of having extramarital relationships. Therefore, this study was conducted with the aim of comparing the effectiveness of emotion-focused therapy and cognitive behavioral therapy on emotional self-regulation and attitudes toward extramarital relationships in marginalized infertile women. Methodology: This study was a quasi-experimental with a pre-test, post-test, and two-month follow-up design with a control group. The research population was infertile women referring to Dr. Elina Bayramzadeh's clinic (surgeon and specialist of gynecologist, obstetrics, and infertility) in the second half of 2024 year. Number of 45 infertile women were selected from 120 people using simple random sampling method and randomly by lottery assigned to three equal groups. Each of the experimental groups underwent 10 sessions of 90 minutes of intervention with emotion-focused therapy and cognitive behavioral therapy, and the control group remained on the waiting list for training. The research instruments included the Affective Style Questionnaire (Hoffman & Kashdan, 2010) and Attitudes toward Infidelity Scale (Whatley, 2008), and the data were analyzed the methods of analysis of variance with repeated measures and Bonferroni post hoc test in SPSS-26 software. Findings: The results of the present study showed that both methods of emotion-focused therapy and cognitive behavioral therapy were effective in increasing emotional self-regulation and reducing attitudes toward extramarital relationships in marginalized infertile women, and the results were maintained at the follow-up stage (P<0.001). Also, the effectiveness of emotion-focused therapy was greater than the cognitive behavioral therapy in increasing emotional self-regulation and reducing attitudes toward extramarital relationships in marginalized infertile women (P<0.001). Conclusion: According to the results of this study, to increase emotional self-regulation and reduce attitudes toward extramarital relationships in vulnerable groups, including marginalized infertile women can be used the emotion-focused therapy.
Mona Fadaei, Bahman Akbari, L. Moghtader· Psychology of Motivation, Be...· 0 citations
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