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.
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
tDCS contraindications
Previous experience with tDCS
Mental health disorder other than unipolar depression or anxiety
Suicidal ideation.
Single group
Transcranial Direct Current Stimulation
DeviceTranscranial Direct Current Stimulation (tDCS) has been suggested to the peripartum period combining antidepressant effects with low risks. In tDCS a low intensity constant current is delivered to the scalp with sub-threshold effect on neurons' resting membrane potential. Long stimulation sessions lead to lasting effects and neuroplastic changes. Local tDCS effects target calcium-dependent synaptic plasticity and distal effects alter the networks' connectivity, synchronicity and oscillatory patterns. tDCS applications aim to counteract the hypoactivity of the frontoparietal network and the left sided hyperactivity of the default mode network associated with depressive symptoms.
Feasibility of the intervention - Number of completed tDCS applications
Study reports on the number of completed tDCS applications
Change from Baseline on the feasibility of the intervention according to patients.
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 intervention - Compliance with symptom monitoring
Study reports on patients compliance with symptom monitoring
Change across treatment and follow-up time points on the feasibility of the assessment procedures - Compliance with outcomes assessment visits
Study Reports on patients compliance with outcomes assessment visits.
Change from Baseline on the feasibility of the intervention according to Health Providers
The Acceptability Scale for tDCS treatments - Halth Professionals version (ACCEPTpro-tDCS) a 15-item self-report questionnaire on acceptability of tDCS by health professionals with a minimum score of 15 and a maximum score of 60. Higher scores correspond to increased acceptability.
Feasibility of the intervention - tDCS Adverse Effects
tDCS Adverse Effects Questionnaire is a 15-item questionnaire to assess adverse effects of tDCS. Scores range between 0-75, and higher scores correspond to increased adverse effects
Feasibility of the intervention -Health Technology Users' Satisfaction Survey
The survey satisfaction is a 8-item questionnaire on user's satisfaction concerning the combined intervention ranging between 0 and 40, and higher scores correspond to increased satisfaction.
Change from Baseline on the feasibility of the assessment procedures - Acceptability of outcomes assessment visits by women
Study reports on the subjective experience of mothers with outcomes assessment visits (response to an open-question).
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Ana Ganho Ávila
Lead sponsor
University of Coimbra
Sponsor institution
Unidade Local de Saúde de Coimbra, EPE
Collaborator
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