AnxietyOnCBTDepNCT01909167
Keeping Well:Online Cognitive Behavioral Therapy (CBT) for Pregnant Women With Depressive Symptoms
A study testing Online Cognitive Behavioral Therapy (CBT) and Treatment as usual in people with Anxiety and Mental Disorders, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Most depression during pregnancy is undetected and untreated although it is known to be harmful both to the woman herself and her future child. When these mental disorders are detected, psychotherapies remain difficult to access, especially in primary care, despite being effective.Also, prenatal depression is known to… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anxiety, Mental Disorders, Postpartum Depression
- What is being tested?
- Online Cognitive Behavioral Therapy (CBT) and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2020to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be pregnant
- Less than 20 weeks gestation,
- To have symptoms of depression (EPDS between 12-22),
- To be computer literate,
- To have an online computer at home,
- English speaking and writing,
Show all 10Show fewer
- Not being in psychiatric or psychological treatment,
- Not having a twin pregnancy,
- Not having undertaken an IVF (In vitro fertilization) procedure,
- Not having the psychiatric problems (based on the patient's notes): psychosis, addiction, history of bipolar disorder, suicidality and other psychiatric diagnoses that do not fall into the affective disorders and/or anxiety disorders spectrum.
Who cannot join
- Not pregnant
- Having severe symptoms of depression (EPDS above 22),
- Computer illiteracy,
- No access to the internet,
- Not speaking or reading English,
- Already being in psychiatric or psychological treatment,
Show all 11Show fewer
- Twin pregnancy,
- Having a medical disorder of pregnancy (including abnormal foetus),
- Having undertaken an IVF (In vitro fertilization) procedure,
- Psychiatric factors based on patient's notes: psychosis, addiction, history of bipolar disorder, suicidality and other psychiatric diagnoses that do not fall into the affective disorders and/or anxiety disorders spectrum.
- After birth for baby data: baby born below 35 weeks, baby with any severe disorders. Mothers will continue to be treated if they want to.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Charlotte's and Chelsea Hospital
London, W12 0NN
About this study
Official title: A Randomized Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) Versus Treatment as Usual (TAU) for Pregnant Women With Symptoms of Depression
Most depression during pregnancy is undetected and untreated although it is known to be harmful both to the woman herself and her future child. When these mental disorders are detected, psychotherapies remain difficult to access, especially in primary care, despite being effective.Also, prenatal depression is known to be a strong risk factor for postnatal depression and may prejudice the mother-infant relationship. This leads us to the following question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more effective treatment for symptoms of depression in pregnant women, than treatment as usual (TAU)?
The proposed randomized controlled trial aims at evaluating the efficacy of internet based cognitive behavioural therapy(CBT) delivered individually via "skype", using video and audio resources, by a fully trained psychotherapist, compared to treatment as usual, in women suffering from symptoms of depression in pregnancy.
Hypothesis The internet based interventions will be more effective at reducing symptoms of depression in pregnant women than treatment as usual, in terms of rates of diagnoses and levels of self rated symptoms of depression.
Read the detailed description
In the last hundred years there has been a great improvement in the physical care of pregnant women, with a corresponding decline in morbidity and mortality for both mother and child. This same is not true of their psychological and psychiatric care in pregnancy, and this is arguably one of the most important unmet aspects of current obstetrics. Previous research has shown that if a mother has high levels of depression or anxiety during pregnancy, including in later gestation,her child is at about double the risk for ADHD(attention deficit hyperactivity disorder), conduct disorder and emotional problems later in development, as well as increased risk for cognitive delay. Prenatal stress, depression and anxiety contribute an estimated 10-15% of the variance in these outcomes. High levels of antenatal anxiety and depression are frequently co-morbid and have been shown to increase risk for preterm delivery, low birth weight, as well as being a major risk factor for postpartum depression and recurrent maternal depression. This in turn, is also associated with increased risk of long-term emotional and behavioral problems in children.
Over 80% of pregnant women with depression are currently undiagnosed and untreated. Most women prefer non pharmacological treatments during gestation and NICE(National Institute for Health and Care Excellence) clinical guidelines recommend Cognitive Behavioral Therapy (CBT) for the treatment of these disorders at this time. CBT has been shown to be effective for the treatment of depression in general; however there have been no randomized controlled trials with pregnant women. Since they may respond differently, they need to be studied directly. The most cost effective way of delivering personalized CBT is internet based and it can be offered online, individually and in real time. Computerized CBT programs have been developed to improve accessibility, but are inflexible, difficult to adapt to patient's specific needs and are associated to low rates of adherence. So, due to the real need of more accessible psychological therapies in primary care, it is crucial to investigate the efficacy of relatively low cost therapeutic tools to improve and broaden individual patient care in pregnancy.
- Conditions
- Anxiety, Mental Disorders, Postpartum Depression, Depressive Symptoms
- Being tested
- Online Cognitive Behavioral Therapy (CBT), Treatment as usual
- Keywords
- Pregnancy, symptoms of depression, anxiety, online CBT therapy, treatment as usual, maternal bonding, postnatal period
- Medical subject headings
- Anxiety Disorders, Mental Disorders, Depression, Postpartum, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive Behavioral Therapy (CBT)Behavioural
CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum.
Treatment as usualOther
Patients randomized to the treatment as usual arm will be advised by their GP,perinatal psychiatric team or mental health midwife concerning treatment.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Patients randomized to the treatment as usual arm will follow advice by their GP(general practitioner), mental health midwife or perinatal psychiatric team concerning treatment. Receives: Other: Treatment as usual |
| Online Cognitive Behavioral Therapy | Active comparator | CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum. Receives: Behavioral: Online Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Edinburgh Postnatal Depression Scale (EPDS)scores from 20 weeks antenatal to 10 weeks postnatal
The primary outcome will be the change in the EPDS scores from before to after intervention in the Cognitive Behavioral Therapy(CBT) online group compared with treatment as usual (TAU) conditions.
Measured: Prenatal: 20, 28, 36weeks.Postnatal: 4 and 10 weeks
Secondary outcomes (3)
Compliance and dropout rates from 20 weeks antenatal to 4 weeks postnatal
Secondary outcome will be to assess the compliance and drop out rates in the CBT and TAU group
Measured: Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks
Changes in anxiety scores from 20 weeks antenatal to 10 weeks postnatal
Secondary outcome will be the changes in anxiety scores in the CBT and TAU group
Measured: Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks
Changes in bonding scores at 10 weeks postnatal
Secondary outcome will to check the differences in the bonding scores in the CBT and TAU group
Measured: Postnatal: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: CI had other commitments
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Kammerer, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909167
- Sponsor's protocol ID
- 13IC0475
- Acronym
- OnCBTDep
- Status last verified
- Jun 2022
- First submitted
- 2 Jul 2013
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Christensen H, Griffiths KM, Mackinnon AJ, Brittliffe K. Online randomized controlled trial of brief and full cognitive behaviour therapy for depression. Psychol Med. 2006 Dec;36(12):1737-46. doi: 10.1017/S0033291706008695. Epub 2006 Aug 29.
PubMed 16938144Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.
PubMed 19278385Hedegaard M, Henriksen TB, Sabroe S, Secher NJ. Psychological distress in pregnancy and preterm delivery. BMJ. 1993 Jul 24;307(6898):234-9. doi: 10.1136/bmj.307.6898.234.
PubMed 8369684Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.
PubMed 18303940Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, Sharp DJ, Araya R, Hollinghurst S, Peters TJ. Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009 Aug 22;374(9690):628-34. doi: 10.1016/S0140-6736(09)61257-5.
PubMed 19700005McClure EM, Goldenberg RL, Bann CM. Maternal mortality, stillbirth and measures of obstetric care in developing and developed countries. Int J Gynaecol Obstet. 2007 Feb;96(2):139-46. doi: 10.1016/j.ijgo.2006.10.010. Epub 2007 Feb 1.
PubMed 17274999National Institute for Clinical Health Excellence (NICE) (2008). Technology appraisal 97: Computerized cognitive behavioural therapy for depression and anxiety (Review of technology appraisal 51), NICE, London.
Oates MR. Adverse effects of maternal antenatal anxiety on children: causal effect or developmental continuum? Br J Psychiatry. 2002 Jun;180:478-9. doi: 10.1192/bjp.180.6.478. No abstract available.
PubMed 12042222O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.
PubMed 12042228Talge NM, Neal C, Glover V; Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61. doi: 10.1111/j.1469-7610.2006.01714.x.
PubMed 17355398Vesga-Lopez O, Blanco C, Keyes K, Olfson M, Grant BF, Hasin DS. Psychiatric disorders in pregnant and postpartum women in the United States. Arch Gen Psychiatry. 2008 Jul;65(7):805-15. doi: 10.1001/archpsyc.65.7.805.
PubMed 18606953
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Internet Based Cognitive Behavioural Therapy (CBT) Versus Treatment as Usual (TAU) for Pregnant Women With Symptoms of Depression
- ClinicalTrials.gov ID
- NCT01909167
- Acronym / sponsor ID
- OnCBTDep / 13IC0475
- Conditions
- Anxiety, Mental Disorders, Postpartum Depression, Depressive Symptoms
- Keywords
- Pregnancy, symptoms of depression, anxiety, online CBT therapy, treatment as usual, maternal bonding, postnatal period
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: CI had other commitments
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most depression during pregnancy is undetected and untreated although it is known to be harmful both to the woman herself and her future child. When these mental disorders are detected, psychotherapies remain difficult to access, especially in primary care, despite being effective.Also, prenatal depression is known to be a strong risk factor for postnatal depression and may prejudice the mother-infant relationship. This leads us to the following question: Will individual Cognitive Behavioral Therapy (CBT) delivered online be a more effective treatment for symptoms of depression in pregnant women, than treatment as usual (TAU)?
The proposed randomized controlled trial aims at evaluating the efficacy of internet based cognitive behavioural therapy(CBT) delivered individually via "skype", using video and audio resources, by a fully trained psychotherapist, compared to treatment as usual, in women suffering from symptoms of depression in pregnancy.
Hypothesis The internet based interventions will be more effective at reducing symptoms of depression in pregnant women than treatment as usual, in terms of rates of diagnoses and levels of self rated symptoms of depression.
Detailed description
In the last hundred years there has been a great improvement in the physical care of pregnant women, with a corresponding decline in morbidity and mortality for both mother and child. This same is not true of their psychological and psychiatric care in pregnancy, and this is arguably one of the most important unmet aspects of current obstetrics. Previous research has shown that if a mother has high levels of depression or anxiety during pregnancy, including in later gestation,her child is at about double the risk for ADHD(attention deficit hyperactivity disorder), conduct disorder and emotional problems later in development, as well as increased risk for cognitive delay. Prenatal stress, depression and anxiety contribute an estimated 10-15% of the variance in these outcomes. High levels of antenatal anxiety and depression are frequently co-morbid and have been shown to increase risk for preterm delivery, low birth weight, as well as being a major risk factor for postpartum depression and recurrent maternal depression. This in turn, is also associated with increased risk of long-term emotional and behavioral problems in children.
Over 80% of pregnant women with depression are currently undiagnosed and untreated. Most women prefer non pharmacological treatments during gestation and NICE(National Institute for Health and Care Excellence) clinical guidelines recommend Cognitive Behavioral Therapy (CBT) for the treatment of these disorders at this time. CBT has been shown to be effective for the treatment of depression in general; however there have been no randomized controlled trials with pregnant women. Since they may respond differently, they need to be studied directly. The most cost effective way of delivering personalized CBT is internet based and it can be offered online, individually and in real time. Computerized CBT programs have been developed to improve accessibility, but are inflexible, difficult to adapt to patient's specific needs and are associated to low rates of adherence. So, due to the real need of more accessible psychological therapies in primary care, it is crucial to investigate the efficacy of relatively low cost therapeutic tools to improve and broaden individual patient care in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual (TAU) | Active comparator | Other: Treatment as usualPatients randomized to the treatment as usual arm will follow advice by their GP(general practitioner), mental health midwife or perinatal psychiatric team concerning treatment. |
| Online Cognitive Behavioral Therapy | Active comparator | Behavioral: Online Cognitive Behavioral Therapy (CBT)CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- To be pregnant
- Less than 20 weeks gestation,
- To have symptoms of depression (EPDS between 12-22),
- To be computer literate,
- To have an online computer at home,
Key exclusion criteria (11 listed)
- Not pregnant
- Having severe symptoms of depression (EPDS above 22),
- Computer illiteracy,
- No access to the internet,
- Not speaking or reading English,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive Behavioral Therapy (CBT)CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum. | Behavioural | Online Cognitive Behavioral Therapy |
| Treatment as usualPatients randomized to the treatment as usual arm will be advised by their GP,perinatal psychiatric team or mental health midwife concerning treatment. | Other | Treatment as usual (TAU) |
Primary outcome
Changes in the Edinburgh Postnatal Depression Scale (EPDS)scores from 20 weeks antenatal to 10 weeks postnatal
Time frame: Prenatal: 20, 28, 36weeks.Postnatal: 4 and 10 weeks
The primary outcome will be the change in the EPDS scores from before to after intervention in the Cognitive Behavioral Therapy(CBT) online group compared with treatment as usual (TAU) conditions.
3 secondary outcomes
Compliance and dropout rates from 20 weeks antenatal to 4 weeks postnatal
Time frame: Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks
Changes in anxiety scores from 20 weeks antenatal to 10 weeks postnatal
Time frame: Prenatal: 20, 28, 36 weeks.Postnatal: 4 and 10 weeks
Changes in bonding scores at 10 weeks postnatal
Time frame: Postnatal: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2022.
- Background: PubMed 16938144Christensen H, Griffiths KM, Mackinnon AJ, Brittliffe K. Online randomized controlled trial of brief and full cognitive behaviour therapy for depression. Psychol Med. 2006 Dec;36(12):1737-46. doi: 10.1017/S0033291706008695. Epub 2006 Aug 29.
- Background: PubMed 19278385Goodman JH. Women's attitudes, preferences, and perceived barriers to treatment for perinatal depression. Birth. 2009 Mar;36(1):60-9. doi: 10.1111/j.1523-536X.2008.00296.x.
- Background: PubMed 8369684Hedegaard M, Henriksen TB, Sabroe S, Secher NJ. Psychological distress in pregnancy and preterm delivery. BMJ. 1993 Jul 24;307(6898):234-9. doi: 10.1136/bmj.307.6898.234.
- Background: PubMed 18303940Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ, Johnson BT. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008 Feb;5(2):e45. doi: 10.1371/journal.pmed.0050045.
- Background: PubMed 19700005Kessler D, Lewis G, Kaur S, Wiles N, King M, Weich S, Sharp DJ, Araya R, Hollinghurst S, Peters TJ. Therapist-delivered Internet psychotherapy for depression in primary care: a randomised controlled trial. Lancet. 2009 Aug 22;374(9690):628-34. doi: 10.1016/S0140-6736(09)61257-5.
- Background: PubMed 17274999McClure EM, Goldenberg RL, Bann CM. Maternal mortality, stillbirth and measures of obstetric care in developing and developed countries. Int J Gynaecol Obstet. 2007 Feb;96(2):139-46. doi: 10.1016/j.ijgo.2006.10.010. Epub 2007 Feb 1.
- BackgroundNational Institute for Clinical Health Excellence (NICE) (2008). Technology appraisal 97: Computerized cognitive behavioural therapy for depression and anxiety (Review of technology appraisal 51), NICE, London.
- Background: PubMed 12042222Oates MR. Adverse effects of maternal antenatal anxiety on children: causal effect or developmental continuum? Br J Psychiatry. 2002 Jun;180:478-9. doi: 10.1192/bjp.180.6.478. No abstract available.
- Background: PubMed 12042228O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.
- Background: PubMed 17355398Talge NM, Neal C, Glover V; Early Stress, Translational Research and Prevention Science Network: Fetal and Neonatal Experience on Child and Adolescent Mental Health. Antenatal maternal stress and long-term effects on child neurodevelopment: how and why? J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):245-61. doi: 10.1111/j.1469-7610.2006.01714.x.
- Background: PubMed 18606953Vesga-Lopez O, Blanco C, Keyes K, Olfson M, Grant BF, Hasin DS. Psychiatric disorders in pregnant and postpartum women in the United States. Arch Gen Psychiatry. 2008 Jul;65(7):805-15. doi: 10.1001/archpsyc.65.7.805.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Kammerer, PhD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Behavioral Therapy (CBT) and Treatment as usual in people with Anxiety and Mental Disorders, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Edinburgh Postnatal Depression Scale (EPDS)scores from 20 weeks antenatal to 10 weeks postnatal (time frame: Prenatal: 20, 28, 36weeks.Postnatal: 4 and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01909167, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2022.