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Keeping Well:Online Cognitive Behavioral Therapy (CBT) for Pregnant Women With Depressive Symptoms

NCT01909167 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-06-27

No results posted yet for this study

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 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.

Conditions

Interventions

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.

OTHER

Treatment as usual

Patients randomized to the treatment as usual arm will be advised by their GP,perinatal psychiatric team or mental health midwife concerning treatment.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Martin Kammerer, PhD · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-01
Completion
2021-07-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01909167 on ClinicalTrials.gov