Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN11284870
ISRCTN11284870
Completed
N/A

Cluster randomised trial to evaluate an integrated behavioural activation and parenting intervention for depressed HIV-positive women in the perinatal period, to enhance child cognitive development at 24 months of age and reduce maternal depression at 12 months postnatal

The University of Oxford0 sites320 target enrollmentNovember 14, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPerinatal depression in women with HIV infectionMental and Behavioural Disorders

Overview

Phase
N/A
Intervention
Not specified
Conditions
Perinatal depression in women with HIV infection
Sponsor
The University of Oxford
Enrollment
320
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39097310/ (added 09/08/2024)

Registry
who.int
Start Date
November 14, 2017
End Date
March 31, 2024
Last Updated
last year
Study Type
Interventional
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Current inclusion criteria as of 14/12/2022:
  • •1\. Pregnant women, 23\-33 weeks gestation at the time of enrolment
  • •2\. Participant is willing and able to give informed consent for participation in the trial
  • •3\. Aged 16 years and above
  • •4\. Diagnosed HIV\-positive
  • •5\. Mother meets criteria for antenatal depression as defined by 9 and greater on the EPDS
  • •6\. Living, or planning to live, within the study area at the time of delivery and for at least 9 months after delivery (the intensive therapy period)
  • •7\. Mother conversant in isiZulu or English
  • •Current inclusion criteria as of 25/01/2019 to 14/12/2022:
  • •1\. Pregnant women, \<33 weeks gestation at time of enrolment

Exclusion Criteria

  • •1\. Any significant disease, disorder or disability which, in the opinion of the Principal Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial. This includes hospitalisation for at least three days for severe psychiatric illness (specifically bipolar disorder, schizophrenia and any other psychoses), or a life\-threatening or other serious physical illness (excluding HIV and tuberculosis)
  • •2\. Current suicidal ideation/thoughts with specific plans and means identified
  • •3\. Substance or alcohol use disorder
  • •4\. Currently receiving a psychological treatment for mental health problems
  • •5\. Participant planning to move away from the study area before 9 months postnatal
  • •6\. Mother not planning to cohabit with the infant

Outcomes

Primary Outcomes

Not specified

Similar Trials

Active, Not Recruiting
N/A
Autologous stem cell transplantation versus alemtuzumab, ocrelizumab, ofatumumab or cladribine in relapsing-remitting multiple sclerosisRelapsing-remitting multiple sclerosisNervous System DiseasesMultiple sclerosis
ISRCTN88667898Sheffield Teaching Hospitals NHS Foundation Trust198
Active, Not Recruiting
N/A
A study regarding rest, recreation and spending time outdoors as support for health and well-being of young cancer survivors
ISRCTN93856392Mid Sweden University150
Completed
N/A
PACT: cluster randomised controlled trial of the ‘Your Care Needs You!’ interventioCare transitionsNot Applicable
ISRCTN17062524Bradford Teaching Hospitals NHS Foundation Trust1,000
Completed
N/A
Impact and cost-effectiveness of integrated care and results-based financing intervention on adherence among pulmonary tuberculosis patients in Georgia
ISRCTN14667607Curatio International Foundation1,153
Completed
N/A
The effectiveness and cost-effectiveness of a structured health intervention for truckers (The SHIFT Study)
ISRCTN10483894oughborough University382