A RCT of psychotherapy in women with nausea and vomiting of pregnancy

Abstract

study question: Does adDing psychological intervention to medical therapy improve nausea/vomiting, psychological symptoms, and pregnancy distress in women with moderate nausea and vomiting of pregnancy (NVP)? summary answer: Three weeks of medical therapy plus psychotherapy yielded statistically and clinically significant improvements in NVP-specific symptoms, anxiety/depression symptoms, and pregnancy distress, compared with medical therapy alone. what is known already: Pregnancy with nausea/vomiting is associated with psychiatric morbidity. Evidence supports the exploration of psychosocial reactions in addition to biochemical markers related to NVP. study design, size, duration: This prospective, open-label, randomized, controlled, parallel-group study was performed at two obstetrics clinics in Iran. Atotal of 86 women, aged 18-40 years, between 6 and 12weeks pregnant withmoderateNVP, more than 5 years of education, and not currently practicing any relaxation techniques or undergoing any psychotherapy, were enrolled from June 2013 to November 2014. participants/materials, setting,methods: Atotal of 86moderateNVPwomenwere randomly allocated to either a control (medical therapy alone) or experimental (medical therapy plus psychotherapy) group. Block randomizationwas achieved using a paper list prepared by an investigatorwith no clinical involvement in the trial. The experimental groupwas given pyridoxine hydrochloride (40 mg daily) for 3weeks, and also received intensivemindfulness-based cognitive therapy (MBCT) in eight individual sessions (50 min each) over 3weeks. The control groupwas given pyridoxine hydrochloride (40 mg daily tablet) for 3weeks alone. All participants completed the Rhodes index of nausea, vomiting and retching (RINVR), the hospital anxiety and depression scale (HADS), and the prenatal distress questionnaire (PDQ) at baseline, 3weeks after baseline at the end of the study, and at a 1 month post-treatment follow-up. Linear mixed-effects models were used, in an intention-to-treat analysis. main results and role of chance: In the psychotherapy plusmedical therapy group, themean relative difference between baseline and post-treatment decreased for RINVR; nausea 8.2 (95%confidence interval (CI) 4.1, 10.2), vomiting 3.5 (95%CI 1.5, 5.8), and total RINVR 11.7 (95% CI 6.5, 16.5), for HADS; anxiety 5.1 (95% CI 3.2, 9.2), depression 3.5 (95% CI 2.4, 7.3), total HADS 7.2 (95% CI 4.4, 12.1), for PDQ; birth concerns 3.3 (95% CI 1.3, 9.1), body concerns 1.5 (95% CI 0.9, 5.1), relationship concerns 2.1 (95% CI 1.2, 5.9), and total PDQ 5.9 (95% CI 3.5, 10.6). At 1month after treatment, the statistically significant improvement in RINVR,HADSand PDQ, aswell as clinical improvement in severity of symptoms,persisted.Medical therapy plus psychotherapy alsoimprovednausea/vomiting symptoms, psychological symptoms, andreducedpregnancy distress more than medical therapy alone, with an effect size of 0.42-0.72 over the trial period. limitations, reasons for caution: The conclusions were limited to a small number of women with moderate NVP. It is unclear whether the difference between the outcomes in the different groupswas related toMBCT alone, or to the extra timeand attention paid to patients in the medical therapy plus psychotherapy. The participants in the study did not remain blind to the treatment and the outcome may only be representative of women with moderate NVP who have been referred to obstetrics clinics. wider implicationsof the findings: Thesefindings showthat adding3weeks ofpsychological interventiontomedical therapymay appear to produce positive therapeutic outcomes upon conclusion of treatment, and 1 month after treatment. This suggests that psychotherapy should be considered as an adjunctive treatment option for women with moderate NVP. In future studies, however, a group of patients who are receiving placebo psychotherapy alongwith medical treatment should be included. Furthermore, an economic evaluation of the addition of psychological intervention to standard medical therapy would be useful.