RCT of At-Home tDCS for Depression in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWomen's College Hospital
About this trial
This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult, ≥18 years of age
Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)
Assessed by a psychiatrist at one of the study recruitment sites during pregnancy, and offered the option of antidepressant medication for treatment but declined to use
Disqualifiers
Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
Trial design
Design model
Parallel
Treatments tested in this trial
active tDCS
Device2mA of direct current delivered in 15 sessions lasting 30 minutes each over 3 weeks
workbook
Other interventionSelf-directed depression in pregnancy workbook completed during each session to control the in-session brain state
sham tDCS
DeviceSham stimulation in which the current turns off after 30 seconds in a slow ramp down that mirrors sensory adaptation in ongoing stimulation, delivered in 15 sessions lasting 30 minutes each over 3 weeks
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: active tDCSExperimental treatment 2 interventions
Group B: controlSham comparator 2 interventions
Trial outcomes
Primary outcomes
1
Depressive symptoms post treatment
Depressive symptoms are measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale (MADRS).The MADRS is a standard rater-administered measure with good reliability and validity in clinical populations; interviewers can achieve and maintain high levels of inter-rater reliability. Nine items are based upon patient report and one on rater observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range 0-60). A MADRS score of \<11 indicates remission. With 80% power, and a type 1 error rate of 0.05 we would require a sample size of 104 (52/group) to detect a statistically significant difference between tDCS and Sham on the primary outcome.
Time frame
End of Week 3 of treatmentSecondary outcomes
1
Remission of depression
Measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale (MADRS).The MADRS is a standard rater-administered measure with good reliability and validity in clinical populations; interviewers can achieve and maintain high levels of inter-rater reliability. Nine items are based upon patient report and one on rater observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range 0-60). A MADRS score of \<11 indicates remission. With 80% power, and a type 1 error rate of 0.05 we would require a sample size of 124 (62/group) to detect a statistically significant difference between tDCS and Sham on this main secondary outcome.
Time frame
4 weeks postpartum2
Depressive symptoms
measured with the 10-item rater-administered Montgomery Asberg Depression Rating Scale (MADRS).The MADRS is a standard rater-administered measure with good reliability and validity in clinical populations; interviewers can achieve and maintain high levels of inter-rater reliability. Nine items are based upon patient report and one on rater observation. Items are rated on a 0-6 continuum (0=no abnormality, 6=severe; score range 0-60). A lower score indicates less severe symptoms.
Time frame
End of Week 1, and Week 2 of treatment, q4 weeks during pregnancy, and 4-, 12-, 26- and 52-weeks postpartum3
Self-reported depressive symptoms
Depressive symptoms will be measured using the Edinburgh Postnatal Depressive Scale (EPDS), a self-report scale that has been validated for use in pregnancy and postpartum. EPDS scores range from 0 to 30. EPDS scores \>12 are predictive of a diagnosis of depression, with higher scores indicating more severe symptoms
Time frame
End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)4
Self-reported anxiety symptoms
Measured using the Generalized Anxiety Disorder-7 (GAD-7) scale which is a self-report scale with good discriminate validity in perinatal populations. GAD-7 scores range from 0 to 21, with higher scores indicating more severe symptoms
Time frame
End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)Other outcomes
1
Concurrent Health Service Use
Self-reported concurrent mental health service use such as psychotherapy or antidepressant use that could confound treatment
Time frame
End of Week 1, Week 2 and Week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)2
Tolerability of Intervention
Assessed using the rater-administered Toronto Side Effects Scale which is an anti-depressant side effects scale
Time frame
End of Week 1, Week 2 and Week 3 of treatment3
Stanford Expectancy Scale
Assesses participant expectations of treatment effectiveness
Time frame
Baseline4
Integrity of Treatment Blindness Questionnaire
Participants report whether they believe they have received the treatment or the sham control.
Time frame
End of session 1, End of Week 3 of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Women's College Hospital
Lead sponsor
Centre for Addiction and Mental Health
Collaborator
Sunnybrook Health Sciences Centre
Collaborator
Source ClinicalTrials.gov