Pharmacotherapy or Psychotherapy? Selective Treatment Depression in The Infertile Women with Recurrent Pregnancy Loss: A Triple-Arm Randomized Controlled Trial

Background: Recurrent pregnancy loss (RPL) and infertility are associated with significant psychiatric complications. The study aimed to investigate the effectiveness of cognitive behavioral therapy (CBT) and sertraline in the treatment of in depression, anxiety, and infertility stress of depressed infertile women with RPL in comparison with usual care. Materials and Methods: A triple-arm randomized controlled trial was carried out on the 60 depressed infertile women with RPL, a population of Infertility Center of Babol city, Iran, who were randomly assigned into three groups: pharmacotherapy with sertraline (n=20), psychotherapy with CBT (n=20), and a usual care as control group (n=20). The participants of psychotherapy received CBT sessions (90 minutes each) over 10 weeks. The participants in the pharmacotherapy group took 50 mg/day sertraline daily for 22 weeks. Outcomes were assessed using the Beck Depression Inventory (BDI-II), fertility problem inventory (FPI), and State-Trait Anxiety Inventory Form Y (STAI-Y) at the beginning of the trial, 10-weeks post-trial, and three months of follow-up. Using statistical package for the social sciences (SPSS) software, data were analyzed. Results: CBT considerably reduced the depression symptoms more than sertraline with a moderate effect size at the post-trial (g=0.11, 95% CI: -0.03 to -0.50). Sertraline showed reduced the scores of state-anxiety more considerably in comparison with control group by a large effect size of post-trial (g=-1.04, 95% CI: -1.70 to -0.38). CBT reduced the total scores of FPI more considerably than sertraline, with a large, small size at follow up-trial [95% CI=-0.03(-0.65, -0.58)]. Both CBT and sertraline were superior to the control group in reducing depression and infertility stress. Conclusion: Depression and infertility stress diminished under CBT and sertraline in depressed infertile women with RPL, with a significant advantage of CBT. Sertraline was superior to CBT in reduction of anxiety (registration number: IRCT201304045931N3).