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Background  Given the prevalence of infertility and consequences of stress, anxiety, and depression during pregnancy and after childbirth, this study aimed to determine the effect of group cognitive behavioral therapy (CBT)-based counseling on perceived stress (primary outcome), anxiety, depression, and quality of life (QoL) of pregnant women with a history of primary infertility.    Method  This controlled randomized clinical trial was conducted on 56 pregnant women with a history of primary infertility referred to Infertility Clinic of Al-Zahra Teaching Hospital of Tabriz. The participants were divided into the intervention ( n  = 28) and control (n = 28) groups using block randomization. The intervention group received group CBT-based counseling after the 14th week of the pregnancy: six in-person sessions and two telephone sessions once per week. The control group received routine care. The Perceived Stress Scale (PSS), Edinburgh Postnatal Depression Scale (EPDS), Van den Bergh’s Pregnancy-Related Anxiety Questionnaire (PRAQ), and Quality of Life in Pregnancy (Gravidarum) (QOL-GRAV) were completed through interviews before and 4 weeks after the intervention by the researcher.    Results  There was not any between-group difference in socio-demographic characteristics, except the gestational age and husband educational level ( p  > 0.05). Both of these variables were adjusted in ANCOVA. After the intervention, the mean scores of perceived stress (mean difference: − 7.3; confidence interval: 95%, from − 0.9 to − 5.6;  p  < 0.001) and anxiety (mean difference:-14.7; confidence interval: 95%. from − 20.6 to - 8.8; p < 0.001) were significantly lower in the intervention group. The mean depression score in the intervention group was lower than the control; however, this between-group difference was not significant (mean difference: − 1.95; confidence interval: 95% from − 3.9 to 0.2;  p  = 0.052). The mean score of quality of life in pregnancy was significantly higher in the intervention group than the control (mean difference: − 5.4; confidence interval: 95% from 3.4 to 7.4;  p  < 0.001).    Conclusion  CBT counseling can affect the perceived stress, anxiety, and quality of life of pregnant women with a history of primary infertility. As a result, this counseling approach is recommended along with other counseling approaches to improve the mental health of pregnant women with a history of infertility.    Trial registration  IRCT Registration Number:  IRCT20111219008459N12 , registered on 10/11/ 2018.

bmc psychiatry

Effect of cognitive behavioral therapy-based counseling on perceived stress in pregnant women with history of primary infertility: a controlled randomized clinical trial