Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands
Department of Obstetrics and Gynaecology, Radboud University Medical Center, PO Box 9101, 6500 HB Nijmegen, The Netherlands.
Hum Reprod. 2016 May;31(5):1046-57. doi: 10.1093/humrep/dew040. Epub 2016 Mar 10.
Is it feasible to evaluate a personalized e-therapy program (Internet based) for women during fertility treatment aimed to reduce the chance of having clinically relevant symptoms of anxiety and/or depression after unsuccessful assisted reproductive technology (ART) treatment within a randomized controlled trial (RCT)?
The evaluation of a personalized e-therapy program is feasible, reflected by good acceptability and integration within current guidelines, but adjustments to the e-therapy program and study design of the RCT have to be made to enhance demand, practicality and efficacy.
Internet-based interventions are promising in reducing psychological distress, especially when treatment is personalized to specific risk profiles of patients. However in fertility care, the beneficial effects of personalized e-therapy on psychological distress and its implementation in daily clinical care still have to be evaluated.
STUDY DESIGN, SIZE, DURATION: To evaluate the feasibility of a personalized e-therapy program, we conducted a two-arm, parallel group, single-blind feasibility randomized controlled trial with a 1:1 allocation. Feasibility was assessed in terms of demand, acceptability, practicality, implementation, integration and limited efficacy. Women were included between 1 February 2011 and 1 June 2013. Women in the control group received care as usual, whereas women in the intervention group received in addition to their usual care access to a personalized e-therapy program. Women were monitored until 3 months after the start of their first ART cycle.
PARTICIPANTS/MATERIALS, SETTING, METHODS: In a university hospital in the Netherlands women who were screened as at risk for emotional adjustment problems and intended to start their first ART cycle were invited, and of them 120 were randomized. Of these women, 48% in the intervention group were compliant to the intervention. Outcome measures associated with the feasibility to analyse this e-therapy program within an RCT were assessed.
It is feasible to evaluate a personalized e-therapy program within an RCT. The acceptability was good, as was the integration within current clinical guidelines and care. However, the demand reflected by a participation rate of 44% was low, since most women declined participation because they felt no need for support at that moment. The practicality of the intervention was moderate illustrated by a relatively high dropout rate (30%) due to practical concerns. The intervention was effective, shown by a reduction in the percentage women having clinically relevant symptoms of anxiety and/or depression in the compliant intervention group compared with the control group 3 months after the first ART cycle; risk difference of 24% (95% CI: 2-46%; ITALIC! P = 0.03).
LIMITATIONS, REASONS FOR CAUTION: The large non-participation rate (56%) needs further evaluation. This also could have influenced results on limited efficacy. Barriers for participation could be assessed more in-depth. Moreover, ∼30% dropped out. This percentage is comparable with other e-health studies. Finally, this is a single-centre study. Generalizability could be enlarged by a multi-centre approach.
In clinical fertility care, personalizing an e-therapy program to the patients' risk profile is promising and feasible. However, in future studies, we recommend modification of the study protocol by for example offering the intervention to the preferred moment in the treatment process. Moreover, adjustment of the study protocol tailored to the found barriers and facilitators is needed. When performing a multi-centre consecutive RCT to assess the effectiveness of personalized e-therapy in fertility care, the findings of this study, for example concerning the preferred timing or reasons for non-participation, could be helpful.
STUDY FUNDING/COMPETING INTERESTS: NutsOhra (Study Number 0702-94) funded this study with an unrestricted grant. There were no competing interests.
ClinicalTrials.gov NCT 01283607.
21 January 2011.
DATE OF FIRST PATIENT'S ENROLMENT: February, 2011.
在一项随机对照试验（RCT）中，评估针对接受辅助生殖技术（ART）治疗后未成功的女性的个性化电子治疗方案（基于互联网）是否可行，旨在降低出现焦虑和/或抑郁临床相关症状的机会？
评估个性化电子治疗方案是可行的，这反映在良好的可接受性和在当前指南内的整合性，但需要对电子治疗方案和 RCT 的研究设计进行调整，以提高需求、实用性和疗效。
基于互联网的干预措施在减轻心理困扰方面很有前景，特别是当治疗针对患者的特定风险特征进行个性化时。然而，在生育护理中，个性化电子治疗对心理困扰的有益效果及其在日常临床护理中的实施仍有待评估。
研究设计、规模、持续时间：为了评估个性化电子治疗方案的可行性，我们进行了一项两臂、平行组、单盲可行性随机对照试验，采用 1:1 分配。通过需求、可接受性、实用性、实施、整合和有限疗效来评估可行性。从 2011 年 2 月 1 日至 2013 年 6 月 1 日期间，招募了被筛选为情绪调整问题风险较高并打算开始首次 ART 周期的荷兰某大学医院的女性。在干预组中，有 48%的女性符合干预条件。评估了与在 RCT 中分析该电子治疗方案相关的可行性结果测量。
在 RCT 中评估个性化电子治疗方案是可行的。可接受性良好，与当前临床指南和护理的整合性良好。然而，由于大多数女性因实际问题而退出，因为她们当时觉得不需要支持，因此反映需求的参与率为 44%较低。干预的实用性为中等，由于实际问题，相对较高的退出率（30%）说明了这一点。干预是有效的，显示出在首次 ART 周期后 3 个月，符合条件的干预组中出现焦虑和/或抑郁临床相关症状的女性比例降低；风险差异为 24%（95%CI：2-46%；ITALIC! P = 0.03）。
局限性、谨慎的原因：高未参与率（56%）需要进一步评估。这也可能影响到有限疗效的结果。可以更深入地评估参与的障碍。此外，约 30%的人退出。这个百分比与其他电子健康研究相似。最后，这是一项单中心研究。通过多中心方法可以扩大其普遍性。
在临床生育护理中，对电子治疗方案进行个性化以适应患者的风险特征是有前途和可行的。然而，在未来的研究中，我们建议修改研究方案，例如在治疗过程中患者喜欢的时刻提供干预措施。此外，需要根据发现的障碍和促进因素调整研究方案。当进行多中心连续 RCT 以评估个性化电子治疗在生育护理中的有效性时，本研究的结果，例如关于首选时间或不参与的原因，可能会有所帮助。
研究资金/利益冲突：NutsOhra（研究编号 0702-94）提供了这项研究的无限制赠款。没有利益冲突。
ClinicalTrials.gov NCT 01283607。
2011 年 1 月 21 日。
2011 年 2 月。
