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Trial registered on ANZCTR


Registration number
ACTRN12615000250538
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
19/03/2015
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Date results provided
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acupuncture for Antenatal Depression.
Scientific title
A pragmatic randomised controlled trial evaluating acupuncture as an antenatal intervention for the treatment of antenatal depression.
Secondary ID [1] 286072 0
None.
Universal Trial Number (UTN)
U1111 - 1166 - 6762
Trial acronym
AcuAnteDep
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Antenatal Depression 294066 0
Condition category
Condition code
Alternative and Complementary Medicine 294366 294366 0 0
Other alternative and complementary medicine
Mental Health 294367 294367 0 0
Depression
Reproductive Health and Childbirth 294368 294368 0 0
Antenatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A one hour depression specific individually tailored acupuncture protocol, will be performed every week for eight weeks, from gestation week 24 through to 31 inclusive, by the chief investigator, on randomised consenting depressed pregnant women.
Intervention code [1] 291060 0
Treatment: Other
Comparator / control treatment
1. A Progressive Muscle Relaxation comparator aimed at providing 'equivalent attention' to the acupuncture intervention is to be included in the same format, that is, weekly one hour sessions over the eight week period from gestation weeks 24-31. These sessions will be performed as individual sessions with the practitioner, as is the case with the acupuncture arm and at the beginning the Kessler 6 will be collected, as well as a brief history in regard to current symptomology. At the end of the session, 5 minutes will be spent assessing post-session feedback. The sessions will focus on achieving overall body relaxation in each session with the first session being dedicated to this. Subsequent sessions will focus on overall body relaxation in addition to a different area of the body for example the back, in which tensing and relaxing of the area will be performed. The participants will be lying comfortably on their sides or back, depending uopon their preference.

2. Due to the morbidity of the participant population all participants will receive standard hospital antenatal mental health service care. In addition, 32 women will be randomised to a 'usual care' group that will provide a control to monitor 1) use of mental health services and 2) depression disease progression. This group will differ to the intervention groups in 2 aspects only namely 1) not receiving interventions and 2) not providing qualitative feedback in regard to their experiences of being involved in 'an intervention'. This group will be required to: provide blood samples at gestation weeks 24 and at the end of week 31; saliva samples at gestation weeks 24, 28 and the end of 31; provide baseline demographic information upon recruitment; EPDS, DASS and WHOQoL at gestations weeks 24, 28 and the end of 31; provide feedback in regard to sleep at gestations weeks 28 and at the end of week 31; have hospital data collected in regard to birthing outcomes and provide the BaM at 6 weeks postnatal. In addition, as these women are not to be regularly seen by the chief investigator, the chief investigator will telephone these women on these week to fill out the Kessler 6, to ensure the women are not worsening dramatically in their depression severity. If a high score is obtained or if the cut-off score is reached, these women will be immediately refered to the emergency mental health services team CoHMET.
Control group
Active

Outcomes
Primary outcome [1] 294162 0
The severity of depression as measured by the Edinburgh Postnatal Depression Scale (EPDS) .
Timepoint [1] 294162 0
Eligibility screening, intervention baseline (week 0), mid intervention (week 4), end of intervention (week 8) and at 6 weeks postnatal.
Primary outcome [2] 294259 0
The duration of depression as measured by the EPDS
Timepoint [2] 294259 0
Baseline, mid (week 4), end of intervention (week 8) and at 6 weeks postnatal.
Secondary outcome [1] 312653 0
Depression, Stress and Anxiety (DASS)
Timepoint [1] 312653 0
Intervention commencement (week 0), mid intervention (week 4), end of intervention (week 8) and 6 weeks postnatal.
Secondary outcome [2] 312654 0
Quality of life - World Health Organisation Quality of Life Scale (WHOQoL-26).
Timepoint [2] 312654 0
Intervention commencement (week 0), mid intervention (week 4), end of intervention (week 8) and 6 weeks postnatal.
Secondary outcome [3] 312655 0
Adjustment to mothering - Being a Mother (BaM-13 Scale)
Timepoint [3] 312655 0
6 weeks postnatal
Secondary outcome [4] 312656 0
Salivary oxytocin
Timepoint [4] 312656 0
Baseline (week 0), mid intervention (week 4) and end of intervention (week 8).
Secondary outcome [5] 312657 0
Leukocyte oxytocin receptor mRNA expression
Timepoint [5] 312657 0
Baseline (week 0) and end of intervention (week 8)
Secondary outcome [6] 366364 0
Salivary cortisol
Timepoint [6] 366364 0
Baseline (week 0), mid intervention (week 4) and end of intervention (week 8).
Secondary outcome [7] 366365 0
Salivary DHEA
Timepoint [7] 366365 0
Baseline (week 0), mid intervention (week 4) and end of intervention (week 8).

Eligibility
Key inclusion criteria
Pregnant women will be eligible if they are: 18 years of age or older, at 24 weeks of gestation, currently experiencing a mood disorder and have a Edinburgh Postnatal Depression Scale (EPDS) scores of greater than or equal to 13.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women experiencing: a major depressive episode more than 2 years duration; psychotic or manic features rendering them incapable of consent; post-traumatic stress disorder and phobia to needles; a current psychiatric assessment of suicidal risk; a condition necessitating bed rest; bleeding disorders and or other major obstetric risks will be excluded; as will those receiving acupuncture or PMR outside of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A study poster will be included in antenatal information packs at two Western Sydney hospitals. Women identified during routine antenatal staff screening, or by clinicians with EPDS greater than or equal to 13 will be referred to the researcher, screened for eligibility and recruited upon signing of a patient information sheet and consent form. Randomisation and concealment will be undertaken by two independent researchers. The sequence will be generated by computer and concealed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Three groups of 78 random numbers were computer generated to enable stratification for the 3 models of antenatal care (obstetrician, standard and caseload midwifery) as well as providing within each group an acupuncture, PMR and usual antenatal depression hospital care allocation. Additional random numbers were generated to ensure sufficient are available for each model of care, as equal numbers are not anticipated to be recruited from the each model, for example, few women are expected to be recruited from the 'obstetrician' model, as this group generally comprises high risk pregnancies and hence, many participant in this group will be ineligible for the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
The morbidity of this population is considered sufficiently serious to maintain existing treatment and the interventions will be evaluated as adjunctive therapies.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This trial is designed to demonstrate a difference in means EPDS scores at the end of the intervention. Assuming a mean score of 8.9 with a standard deviation (SD) of 5 in the acupuncture group versus 13 with a SD of 6.5 in the usual care group, with an alpha value of 0.05 and a power of 80%, a sample size of 75 participants is required. High attrition rates of up to 30% have been reported in this population, hence an additional 30% will be recruited, resulting in a total sample size of 96, with 32 participants being randomized into each arm. A range of data analysis techniques will be used including descriptive statistics (mean, standard deviations, frequency and percentages) to describe the characteristics of the study population. An intention to treat analysis will be undertaken, with between group differences explored using mixed effects ANOVA for primary and secondary endpoints for depression, stress, anxiety and quality of life EPDS, DASS and WHOQoL. Further statistical advise will be sought in regard to exploring the effect on OT / OT-R between groups. Effect sizes will be reported with 95% confidence intervals. The analysis will be considered significant if the p value is less than 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/02/2015
Actual
5/03/2015
Date of last participant enrolment
Anticipated
29/07/2016
Actual
30/09/2016
Date of last data collection
Anticipated
20/02/2018
Actual
3/04/2017
Sample size
Target
96
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3371 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 3372 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 9160 0
2560 - Campbelltown
Recruitment postcode(s) [2] 9161 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 290656 0
University
Name [1] 290656 0
Western Sydney University - National Institute of Complementary Medicine
Country [1] 290656 0
Australia
Primary sponsor type
University
Name
Western Sydney University - National Institute of Complementary Medicine
Address
Building 5, Campbelltown Campus,
Locked Bag 1797,
Penrith NSW 2751.
Country
Australia
Secondary sponsor category [1] 289349 0
Hospital
Name [1] 289349 0
Campbelltown Hospital
Address [1] 289349 0
Therry Road, Campbelltown, NSW 2560.
Country [1] 289349 0
Australia
Secondary sponsor category [2] 289406 0
Hospital
Name [2] 289406 0
Camden Hospital
Address [2] 289406 0
Menangle Road, Camden, NSW 2570.
Country [2] 289406 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292287 0
Research and Ethics Office, South Western Sydney Local Health District (SWSLHD)
Ethics committee address [1] 292287 0
Ethics committee country [1] 292287 0
Australia
Date submitted for ethics approval [1] 292287 0
25/08/2014
Approval date [1] 292287 0
02/02/2015
Ethics approval number [1] 292287 0
HREC/14/LPOOL/400

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54490 0
Ms Simone Ormsby
Address 54490 0
Postal address:
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia

Physical address:
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 54490 0
Australia
Phone 54490 0
+61 2 9685 4700
Fax 54490 0
+61 2 9685 4760
Email 54490 0
simone.ormsby@westernsydney.edu.au
Contact person for public queries
Name 54491 0
Caroline Smith
Address 54491 0
Postal address:
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia

Physical address:
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145

Australia
Country 54491 0
Australia
Phone 54491 0
+61 2 9685 4700
Fax 54491 0
+61 2 9685 4760
Email 54491 0
caroline.smith@westernsydney.edu.au
Contact person for scientific queries
Name 54492 0
Caroline Smith
Address 54492 0
Postal address:
NICM Health Research Institute
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Australia

Physical address:
Building J
Western Sydney University
Westmead Campus
158-160 Hawkesbury Rd
Westmead NSW 2145
Country 54492 0
Australia
Phone 54492 0
+61 2 9685 4700
Fax 54492 0
+61 2 9685 4760
Email 54492 0
caroline.smith@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval was not sought in this regard at trial commencement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial.2020https://dx.doi.org/10.1016/j.jad.2020.05.089
N.B. These documents automatically identified may not have been verified by the study sponsor.