ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Alternative and Complementary Medicine

Other alternative and complementary medicine

Mental Health

Depression

Reproductive Health and Childbirth

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]

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]

The severity of depression as measured by the Edinburgh Postnatal Depression Scale (EPDS) .

Timepoint [1]

Eligibility screening, intervention baseline (week 0), mid intervention (week 4), end of intervention (week 8) and at 6 weeks postnatal.

Primary outcome [2]

The duration of depression as measured by the EPDS

Timepoint [2]

Baseline, mid (week 4), end of intervention (week 8) and at 6 weeks postnatal.

Secondary outcome [1]

Depression, Stress and Anxiety (DASS)

Timepoint [1]

Intervention commencement (week 0), mid intervention (week 4), end of intervention (week 8) and 6 weeks postnatal.

Secondary outcome [2]

Quality of life - World Health Organisation Quality of Life Scale (WHOQoL-26).

Timepoint [2]

Intervention commencement (week 0), mid intervention (week 4), end of intervention (week 8) and 6 weeks postnatal.

Secondary outcome [3]

Adjustment to mothering - Being a Mother (BaM-13 Scale)

Timepoint [3]

6 weeks postnatal

Secondary outcome [4]

Salivary oxytocin

Timepoint [4]

Baseline (week 0), mid intervention (week 4) and end of intervention (week 8).

Secondary outcome [5]

Leukocyte oxytocin receptor mRNA expression

Timepoint [5]

Baseline (week 0) and end of intervention (week 8)

Secondary outcome [6]

Salivary cortisol

Timepoint [6]

Baseline (week 0), mid intervention (week 4) and end of intervention (week 8).

Secondary outcome [7]

Salivary DHEA

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Campbelltown Hospital - Campbelltown

Recruitment hospital [2]

Camden Hospital - Camden

Recruitment postcode(s) [1]

2560 - Campbelltown

Recruitment postcode(s) [2]

2570 - Camden

Funding & Sponsors

Funding source category [1]

University

Name [1]

Western Sydney University - National Institute of Complementary Medicine

Address [1]

Building 5, Campbelltown Campus,
Locked Bag 1797,
Penrith NSW 2751.

Country [1]

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]

Hospital

Name [1]

Campbelltown Hospital

Address [1]

Therry Road, Campbelltown, NSW 2560.

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Camden Hospital

Address [2]

Menangle Road, Camden, NSW 2570.

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research and Ethics Office, South Western Sydney Local Health District (SWSLHD)

Ethics committee address [1]

Research and Ethics Office
South Western Sydney Local Health District (SWSLHD)
Locked Bag 7103 Liverpool BC NSW 1871.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/08/2014

Approval date [1]

02/02/2015

Ethics approval number [1]

HREC/14/LPOOL/400

Summary

Brief summary

Depression in pregnancy is common and also associated with detrimental consequences to both mother and child. Current treatments are limited in that they are not universally effective and also many pregnant women are reluctant to take anti-depressant medications during pregnancy, due to fear of negative foetal effects. Acupuncture may offer a safe alternative as preliminary evidence is suggestive that it is effective in reducing depressive symptoms both during pregnancy and also into the postnatal period. In order to strengthen this evidence base further research is required. How acupuncture may achieve this effect is also unknown and in order to investigate this further, this study aims to assess whether acupuncture positively influences a hormone that is involved in stress buffering, mood stabilisation and maternal / infant bonding.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Simone Ormsby

Address

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

Australia

Phone

+61 2 9685 4700

Fax

+61 2 9685 4760

[email protected]

Contact person for public queries

Name

Prof Caroline Smith

Address

Country

Australia

Phone

+61 2 9685 4700

Fax

+61 2 9685 4760

[email protected]

Contact person for scientific queries

Name

Prof Caroline Smith

Address

Country

Australia

Phone

+61 2 9685 4700

Fax

+61 2 9685 4760

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Ormsby, S. M., Smith, C. A., Dahlen, H. G., Hay, P... [More Details]
Study results article	Yes	Ormsby, S. M., Dahlen, H. G., & Smith, C. A. (2018... [More Details]
Study results article	Yes	Ormsby, S. M., Dahlen, H. G., Ee, C. C., Keedle, H... [More Details]
Plain language summary	No	Antenatal depression is common, with wide-ranging ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial.	2020	https://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.

Trial Review

Documents added manually

Documents added automatically