Therapist-guided internet-based cognitive behavioral therapy versus face-to-face CBT for depression/anxiety symptoms in infertile women with adjustment disorders: A randomized controlled trial

ABSTRACT Objective: The present study compared the effectiveness of ICBT to face-to-face CBT on the improvement of adjustment disorder symptoms in infertile women. Method: In a pragmatic, multi-center (public or private), single-blinded, non-inferior randomized controlled trial (RCT), 152 patients with AD (100 women in public center and 52 women in private canter) were assigned to ICBT and CBT. Primary outcomes were Adjustment Disorder New Module-20 (ADNM-20) and Hospital Anxiety and Depression (HADS). Secondary outcomes were the Fertility Problem Inventory (FPI) and Fertility Adjustment Scale (FAS). Results: “Peaceful mind” ICBT was feasible and accessible for delivering the treatment to infertile women with AD. At end-of-treatment, improvements in ICBT were non-inferior to CBT for symptoms of AD, anxiety, and depression. Additionally, the non-inferiority of ICBT to CBT was maintained at a three-month follow-up. Conclusions: ICBT was non-inferior to CBT in improving mental symptoms in infertile women with AD.