Study Background and Disease Burden
Anxiety during pregnancy is a common and clinically significant issue, particularly in women with suspected fetal malformations. These women face heightened emotional distress triggered by uncertainty regarding fetal health, leading to elevated pregnancy-specific stress and anxiety symptoms that may affect both maternal and fetal outcomes. Traditional cognitive behavioral therapy (CBT) has proven effective in managing anxiety; however, pregnant women often face barriers such as limited mobility, time constraints, and stigma, which reduce access to face-to-face therapy sessions. Internet-based interventions, particularly internet-based emotion-focused cognitive behavioral therapy (IECBT), offer a promising solution by delivering accessible, flexible psychological support tailored to the emotional challenges of pregnancy complications. Yet, there is limited high-quality randomized evidence evaluating IECBT’s effectiveness in this vulnerable population, particularly regarding its sustained efficacy and the role of booster sessions or spouse participation in therapy outcomes.
Study Design
This study was a randomized, four-arm parallel-group controlled trial conducted among 140 pregnant women who displayed anxiety symptoms before 20 weeks’ gestation and had ultrasound or clinical suspicion of fetal malformation. Participants were allocated equally into four intervention groups of 35 women each:
1. IECBT alone
2. IECBT with booster sessions
3. IECBT with spouse participation
4. IECBT with spouse participation plus booster sessions
The core IECBT intervention involved six weekly 50-minute therapist-led sessions conducted online with the participants. For groups involving spouse participation, an additional 20-minute online therapist-led session was offered to the spouses. Booster session groups received monthly 50-minute follow-up IECBT sessions post-intervention until delivery.
Outcomes were assessed using validated questionnaires: Spielberger’s State Anxiety Inventory, Pregnancy-Specific Stress Questionnaire, Intolerance of Uncertainty Scale, and Emotion Regulation Questionnaire. Assessments occurred at baseline, immediately after the 6-week intervention, and at 3-month and 6-month post-trial follow-ups.
Key Findings
All four IECBT models demonstrated statistically significant improvements in anxiety symptoms, pregnancy-specific stress, intolerance of uncertainty, and emotional regulation immediately after therapy completion. These psychological benefits were sustained at the 3-month and 6-month follow-ups, underlining the persistence of IECBT’s positive effects over time.
Notably, no single IECBT model showed superiority over the others across the primary and follow-up assessments. This indicates that adding booster sessions or involving spouses, within the parameters of this study, did not significantly enhance outcome improvements compared to IECBT alone.
Participants across all groups reported high satisfaction with the IECBT interventions, reflecting good acceptability and engagement irrespective of intervention complexity.
Expert Commentary
This trial contributes valuable evidence supporting internet-delivered, emotion-focused CBT as an effective intervention for managing psychological distress in pregnant women with suspected fetal malformations. The use of IECBT addresses accessibility challenges and provides flexible mental health support tailored to pregnancy-specific emotional needs.
However, it is important to contextualize findings with study limitations: booster sessions and spouse involvement sessions were not therapist-guided beyond the initial structured therapy, potentially diminishing their impact. Cultural dynamics surrounding masculinity and perceived spousal roles may have influenced spouse engagement, limiting their therapeutic contribution. Additionally, the study did not include long-term follow-up beyond six months or postnatal psychological outcomes, especially concerning whether fetal malformations were confirmed or ruled out, which remains a gap for future research.
Biologically, reducing intolerance to uncertainty and improving emotion regulation are key therapeutic targets in cognitive behavioral frameworks and align with theoretical models that emotional distress during pregnancy arises from uncertainty and perceived loss of control.
Conclusion
The study robustly demonstrates that internet-based emotion-focused CBT effectively alleviates anxiety, pregnancy-specific stress, intolerance of uncertainty, and dysregulated emotions in women confronted with suspected fetal malformations. Benefits are sustained for at least six months post-intervention. While booster sessions and spousal participation did not confer additional benefits under current implementation, IECBT remains a viable core psychological intervention to support this at-risk population. Future research should explore optimizing spousal involvement, therapist-guided boosters, and examine long-term maternal and child outcomes.
References
Aligoltabar S, Nasiri-Amiri F, Khafri S, Adib-Rad H, Barat S, Pahlavan Z, Taheriotaghsara S, Rayati M, Faramarzi M. Efficacy of internet-based emotion-focused cognitive behavior therapy (IECBT) in improving stress and anxiety of women with suspected fetal malformation: A randomized controlled trial. J Behav Ther Exp Psychiatry. 2025 Sep;88:102033. doi: 10.1016/j.jbtep.2025.102033. Epub 2025 Mar 29. PMID: 40209507.
