Home-based Transcranial Direct Current Stimulation in Postpartum Depression: the Feasibility Study and Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Change from Baseline on the feasibility of the intervention according to patients.
研究概览
简要总结
Postpartum Depression (PPD) is a Major Depressive (MD) Disorder occurring within the 12 months after delivery with negative effects to the mother, the child and the family and an estimated prevalence in Europe of 10-15%. Non-invasive Transcranial Direct Current Stimulation (tDCS) has been suggested to PPD, as it combines antidepressant effects with low risks, being equivalent to pharmacotherapy, and showing faster response than psychotherapy. tDCS uses a weak electric current applied to the scalp, modulating neurons' firing rate and neuroplasticity of cerebral circuits to counteract dysfunctional connectivity and inter-hemispheric imbalance in MD. tDCS portability led to its introduction as a home-based intervention and trials assessing home-based tDCS in MD were successful, proved its feasibility and showed good acceptance and benign effect in patients' self-efficacy. Hence, combining home-based tDCS with eHealth systems to support data collection and teleHealth for remote health care has shown positive results in other neuropsychiatric disorders.
To uptake tDCS to PPD, further research is needed. To pursue the needed regulatory steps, current consensus on the primary hypothesis of efficacy is that future phase-III studies must be supported by the identification of biotypes of depression and should include cost-effectiveness analysis to model its economic advantage and inform Health Technology Analysis.
4MUMs, within an iterative user-centred and co-design approach will adopt a combined intervention (home-based tDCS + eHealth system + teleHealth system) for PPD, conduct a dynamic feasibility study of the data collection procedures and intervention, and test these in a single-arm pilot study towards the first large-sample multicentre Phase-III RCT protocol aimed at testing home-based tDCS efficacy in PPD.
详细描述
Study aims and endpoints:
Aim 1: Conduct a feasibility study to
- Determine the feasibility and acceptability of the combined intervention in PPD, by estimating the feasibility and acceptability of i) the home-based tDCS intervention; ii) the eHealth system; iii) the teleHealth system, by women and HP.
- Determine the feasibility and acceptability of data collection and data analysis procedures of outcome and moderator variables for efficacy studies, namely of psychological functioning of mothers and babies (including neurodevelopment), the dyad, cost-benefit, and neuroinflammatory and stress levels; specifically, acceptability and compliance with the procedures will be evaluated
- Evaluate the safety of the combined intervention in PPD
- Estimate the parameters for the protocol of the future multicentric RCT aimed to establish the efficacy of the combined intervention
Aim 2: Conduct a pilot study to
a) Gather preliminary evidence of the efficacy of the combined intervention in PPD as measured by psychological functioning of mothers, babies and the dyad, neuroinflammatory and stress levels and quality of life (QoL), and the role of study moderators (genetic/epigenetic profiles of mothers and babies) in affecting main outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Medication-free women with moderate to severe MD episode according to the Montgomery Asberg Depression Rating Scale (MADRS>7), and peripartum onset, diagnosed before delivery or between the second week and month 6 postpartum
- •Between 18-45 years of age
- •Pregnancy to term
- •Uncomplicated delivery to a healthy newborn
- •Must be able to manage the technical aspects of the intervention.
排除标准
- •tDCS contraindications
- •Previous experience with tDCS
- •Mental health disorder other than unipolar depression or anxiety
- •Suicidal ideation.
结局指标
主要结局
Change from Baseline on the feasibility of the intervention according to patients.
时间窗: At baseline, at end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.
The Acceptability Scale for tDCS treatments - patients version (ACCEPT-tDCS) is a 15-item self-report questionnaire on acceptability of tDCS by patients with a minimum score of 15 and a maximum score of 60. Higher scores correspond to increased acceptability.
Change across treatment and follow-up time points on the feasibility of the assessment procedures - Compliance with outcomes assessment visits
时间窗: At the end of treatment cycle 1 and the end of treatment cycle 2 (if 2 cycles are prescribed; each cycle is 3 weeks), and at 1 month follow-up
Study Reports on patients compliance with outcomes assessment visits.
Change from baseline depressive symptoms.
时间窗: At baseline and weekly, from week 1 to week 3 (or from week 1 to week 6 if 2 cycles were prescribed) and 1 month follow-up
Change across treatment and follow-up time points on the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire to assess the presence and severity of clinically relevant depressive symptoms in the prior week using a 4-point scale. Self-report questionnaire to assess depressive symptoms in the postpartum (through e-health). Scores range between 10 and 40 and higher scores correspond to increased presence/severity of depressive symptoms.
Feasibility of the intervention - Number of completed tDCS applications
时间窗: At end of treatment (cycle 1 or 2; each cycle is 3 weeks)
Study reports on the number of completed tDCS applications
Change across treatment and follow-up time points on the feasibility of the intervention - Compliance with symptom monitoring
时间窗: Weekly from week 1 to week 3 (or week 6 if 2 cycles; each cycle is 3 weeks) and at 1 month follow-up
Study reports on patients compliance with symptom monitoring
次要结局
- Change from Baseline in Clinical Status according to difficulties in emotion regulation.(At baseline and weekly during the 3 weeks of tDCS cycle (or during 6 weeks if tDCS cycle 2 is prescribed) and at one month follow-up)
- Change from Baseline on the feasibility of the intervention according to Health Providers(At baseline, at end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Feasibility of the intervention -Health Technology Users' Satisfaction Survey(At the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Estimate of retention(At the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Change from Baseline on the feasibility of the assessment procedures - Acceptability of outcomes assessment visits by women(At baseline, at the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Change from Baseline in Clinical Status according to Ruminative Thinking(At baseline and weekly during the 3 weeks of tDCS cycle (or during 6 weeks if tDCS cycle 2 is prescribed) and at one month follow-up)
- Feasibility of the intervention - tDCS Adverse Effects(Daily during intervention (3 weeks or 6 weeks when adequate) and 1 month follow-up)
- Estimate of recruitment(At the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Change from Baseline on the feasibility of the assessment procedures - Acceptability of outcomes assessment visits (newborn-infants)(At baseline, at the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Change from Baseline in Clinical Status according to depressive symptoms.(At baseline and weekly during the 3 weeks of tDCS cycle (or during 6 weeks if tDCS cycle 2 is prescribed) and at one month follow-up)
- Change from Baseline in Clinical Status according to anxiety symptoms(At baseline and weekly during the 3 weeks of tDCS cycle (or during 6 weeks if tDCS cycle 2 is prescribed) and at one month follow-up)
- Estimate of dropouts(At the end of treatment (cycle 1 or 2; each cycle is 3 weeks) and 1 month follow-up.)
- Change from Baseline in Clinical Status according to Sleep quality(At baseline and weekly during the 3 weeks of tDCS cycle (or during 6 weeks if tDCS cycle 2 is prescribed) and at one month follow-up)
- Change from Baseline in bonding quality in mother-baby dyad.(At week 1, week 3 (and week 6 if two tDCS cycles where prescribed; each cycle is 3 weeks) of treatment and at 1 month follow-up.)
- Change from Baseline in parental stress.(At week 1, week 3 (and week 6 if two tDCS cycles where prescribed; each cycle is 3 weeks) of treatment and at 1 month follow-up.)
- Quality of Life according to the EuroQol five dimensions, five level questionnaire - EQ-5D-5L(At baseline and 1 month follow-up)
- Mother epigenetic biomarkers (collected during at-home visits)(At baseline and 1 month follow-up)
- Infant and Toddler Development(At baseline and 1 month follow-up)
- Mother genetic biomarkers (collected during at-home visits)(At baseline)
- Quantification of neuroinflammatory biomarkers of mothers (collected during at-home visits)(At baseline and 1 month follow-up)
- Baby epigenetic biomarkers (collected during at-home visits)(At baseline and 1 month follow-up)
- Quantification of neuroinflamatory biomarkers of babies (collected during at-home visits)(At baseline and 1 month follow-up)
- Baby genetic biomarkers (collected during at-home visits)(At baseline)
研究者
Ana Ganho Ávila
Researcher
University of Coimbra