Mahbobeh Faramarzi1, Shala Yazdani2, Shahnaz Barat3. 1. Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran. 2. Infertility and Reproductive Health Research Center, Health Research Institute, Obstetrics & Gynecology Department, Babol University of Medical Science, Babol, Iran shahla_yazdani_1348@yahoo.com. 3. Infertility and Reproductive Health Research Center, Health Research Institute, Obstetrics & Gynecology Department, Babol University of Medical Science, Babol, Iran.
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. A total of 86 women, aged 18-40 years, between 6 and 12 weeks pregnant with moderate NVP, 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: A total of 86 moderate NVP women were randomly allocated to either a control (medical therapy alone) or experimental (medical therapy plus psychotherapy) group. Block randomization was achieved using a paper list prepared by an investigator with no clinical involvement in the trial. The experimental group was given pyridoxine hydrochloride (40 mg daily) for 3 weeks, and also received intensive mindfulness-based cognitive therapy (MBCT) in eight individual sessions (50 min each) over 3 weeks. The control group was given pyridoxine hydrochloride (40 mg daily tablet) for 3 weeks 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, 3 weeks 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 plus medical therapy group, the mean 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 1 month after treatment, the statistically significant improvement in RINVR, HADS and PDQ, as well as clinical improvement in severity of symptoms, persisted. Medical therapy plus psychotherapy also improved nausea/vomiting symptoms, psychological symptoms, and reduced pregnancy 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 groups was related to MBCT alone, or to the extra time and 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 IMPLICATIONS OF THE FINDINGS: These findings show that adding 3 weeks of psychological intervention to medical therapy may 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 along with medical treatment should be included. Furthermore, an economic evaluation of the addition of psychological intervention to standard medical therapy would be useful.
RCT Entities:
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. A total of 86 women, aged 18-40 years, between 6 and 12 weeks pregnant with moderate NVP, 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: A total of 86 moderate NVP women were randomly allocated to either a control (medical therapy alone) or experimental (medical therapy plus psychotherapy) group. Block randomization was achieved using a paper list prepared by an investigator with no clinical involvement in the trial. The experimental group was given pyridoxine hydrochloride (40 mg daily) for 3 weeks, and also received intensive mindfulness-based cognitive therapy (MBCT) in eight individual sessions (50 min each) over 3 weeks. The control group was given pyridoxine hydrochloride (40 mg daily tablet) for 3 weeks 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, 3 weeks 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 plus medical therapy group, the mean 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 1 month after treatment, the statistically significant improvement in RINVR, HADS and PDQ, as well as clinical improvement in severity of symptoms, persisted. Medical therapy plus psychotherapy also improved nausea/vomiting symptoms, psychological symptoms, and reduced pregnancy 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 groups was related to MBCT alone, or to the extra time and 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 IMPLICATIONS OF THE FINDINGS: These findings show that adding 3 weeks of psychological intervention to medical therapy may 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 along with medical treatment should be included. Furthermore, an economic evaluation of the addition of psychological intervention to standard medical therapy would be useful.