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).