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Can better sleep health during pregnancy regulate depressive symptoms in women with a previous history of depression?

Can better sleep health during pregnancy regulate depressive symptoms in women with a previous history of depression?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617000055303
Acronym
Sleep HAPi (Sleep Health and Pregnancy Information)
Enrollment
22
Registered
2017-01-11
Start date
2017-03-01
Completion date
2018-02-14
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Pregnancy brings enormous change to a woman’s life. Hormonal, physiological, and emotional changes alter many systems in the body, making it difficult for pregnant women to get enough quality sleep. In fact, by the third trimester 97% of women will experience sleep disruption of some kind. Evidence from other populations show that having poor quality sleep can trigger depression. Furthermore sleep and depression share a bidirectional relationship – poor sleep increases the risk of depression and depression contributes to poor sleep, causing a self-sustaining negative state. To add a further layer, two primary risk factors for depression in pregnancy are: 1) a prior history of depression; and 2) poor sleep quality. Pregnant women with a prior history of depression are thus highly vulnerable. The effects of poor sleep and depression can be severely and directly detrimental to health. It can also have tragic implications on relationships and one’s ability to enjoy life. Healthy mothers, raising healthy children are fundamental to growing strong communities. At such a crucial time in life, the health, relationships and enjoyment of women and their families are of paramount importance. The purpose of this research is to evaluate the sleep quality of women throughout pregnancy (through both objective and subjective measures), establish an individualised sleep health program to facilitate good sleep patterns and habits and evaluate if better sleep health can avert depressive symptoms and the self-sustaining nature of poor sleep quality and depression. Investigating the efficacy of an intervention such as this, has been recently suggested in current literature, and is the next important step in preventing both antenatal and postnatal depression.

Interventions

Sleep HAPi is an individualised education package of information and strategies for healthy sleep during pregnancy, tailored for each participant in each trimester. Sleep HAPi is an intervention specifically designed for this study and will be used in each of the three intervention weeks; one intervention per trimester (this corresponds to time points 2, 3 and 4 – see ‘Study Process’ document attached to this ANZCTR registration form). The package comprises of: + A booklet providing evidence

Sleep HAPi is an individualised education package of information and strategies for healthy sleep during pregnancy, tailored for each participant in each trimester. Sleep HAPi is an intervention specifically designed for this study and will be used in each of the three intervention weeks; one intervention per trimester (this corresponds to time points 2, 3 and 4 – see ‘Study Process’ document attached to this ANZCTR registration form). The package comprises of: + A booklet providing evidence based material on: * The basic physiology of sleep; * The benefits of healthy sleep and consequences of poor sleep; * The fundamental principles of achieving healthy sleep; * Trimester specific sleep changes and expectations; * Trimester specific sleep suggestions. + A summary of the actigraphy data from the measurement week prior. The package is designed to be expanded on over the three intervention weeks, with the majority of information provided and discussed in the first intervention week, with additional trimester specific information and actigraphy data added as the study, and pregnancy, progress. The study will utilise both subjective and objective measures of sleep. The subjective measures will be obtained from six questionnaires at all six time points (see ‘Study Process’ attached). The first questionnaire at T1 (study commencement) is expected to take 10 minutes, the questionnaire at T2 (11-14 weeks gestation) approximately 30-40 minutes, the questionnaires at T3 (21-24 weeks gestation), T4 (32-35 weeks gestation), T5 (6 weeks postnatal) and T6 (12 weeks postnatal) approximately 20-30 minutes each. The first questionnaire will be completed at the initial meeting with the participant, while the remainder will be posted to the participant for completion in their own time within a specified date range. The objective measures will be obtained from a total of six weeks of actigraphy and sleep diaries at T2, T3 and T4 - two separate weeks at each time point, one before the intervention and one after. The participant will wear an actiwatch and fill out a sleep diary for a seven day period. It is expected that filling out the sleep diaries will take no more than 10 minutes per day. Analysis of the objective and subjective measures will elucidate the participant’s sleep behaviours and patterns, which will then be discussed with the participant during the intervention. Relevant suggestions from the Sleep HAPi booklet will then be explored in an attempt to improve sleep. The actigraphy week immediately following each intervention will indicate adherence and whether the sleep suggestions are improving the participant’s sleep. The interventions are a one-on-one, face-to-face meeting scheduled at T2, T3 and T4. These meetings, delivered by a Sleep Scientist, will take place at either the participant’s home, or at the Sleep/Wake Research Centre’s meeting rooms. The first intervention at T2 is expected to be 60-90 minutes in length, with subsequent interventions at T3 and T4 expected to be 45-60 minutes in length. Intervention fidelity is addressed by having a single researcher delivering the education package. Intervention adherence will be assessed using an action and reflection plan. At each intervention time point, the researcher and participant will discuss and develop a sleep action plan. Actigraphy in the week following the intervention will be assessed to determine adherence to the action plan, and the subsequent intervention will be used to reflect on the effectiveness of the plan.

Sponsors

Massey University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Women will be eligible to participate if they: *Are less than 13 weeks gestation; *Have had a diagnosis of depression; *Are over 16 years of age; *Are primiparous; *Have no children living at home under the age of three; *Are proficient in English.

Exclusion criteria

Women will be excluded if they: *Are taking any depressive medication; *Have current depressive symptomology; *Have a diagnosed sleep conditions (such as OSA or restless leg syndrome); *Have a history of severe mental illness, such as psychotic disorders.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026