None listed
Conditions
Brief summary
Maternal sleep disturbance is a significant and widespread complaint during the postpartum period. Though some aspects of sleep eventually improve over time, some mothers continue to experience poor sleep with persistent difficulties in initiating and reinitiating sleep. These postnatal sleep complaints have been associated with a range of deleterious outcomes, including fatigue, sleepiness, and symptoms of depression/anxiety. Despite the prevalence and associated negative outcomes of postnatal sleep disturbance, research investigating potential interventions to promote maternal sleep is scarce, representing a significant gap in the current literature. We plan to examine the efficacy of non-pharmacological interventions to improve sleep and wellbeing in sleep-disturbed mothers: (1) Cognitive Behavioural Therapy (CBT) and (2) Light and Dark Therapy (LDT). The CBT arm will involve strategies to target healthy sleep habits and management of daytime symptoms (including fatigue), delivered via emails with therapist assistance. The LDT arm will involve participants wearing light glasses each morning and adhering to recommendations for appropriate light exposure at night. Interventions will be personalised in an orientation call with a researcher in which specific recommendations will be made based on the participants’ individual needs. There will be four conditions: (1) a CBT-only group; (2) a LDT-only group; (3) a combined CBT-LDT group; and (4) a waitlist control that will receive CBT emails following trial completion. The active intervention phase will be six weeks, with four assessment time-points: (1) baseline; (2) mid-point – Week 3; (3) post-intervention – Week 6; and (4) follow-up – Week 10. This aims of this study are to: 1) Investigate the efficacy of CBT, LDT, and the combinations of LDT and CBT in the reduction of maternal sleep complaints as the primary outcome, and maternal fatigue, sleepiness, and mood as secondary outcomes. 2) Explore predictors and mediators of treatment effects. 3) Evaluate whether the combination of CBT and LDT supersede the effects of either intervention delivered alone.
Interventions
Interventions will be therapist-assisted with self-directed/automated components. A provisional psychologist trained in the study protocol under the supervision of a clinical psychologist, will interact with participants in the three intervention conditions via phone to personalise interventions, providing recommendations of certain modules through an orientation phone call which will take up to 90 minutes. Participants will be randomised to conditions.
Cognitive Behavioural Therapy interventio
Interventions will be therapist-assisted with self-directed/automated components. A provisional psychologist trained in the study protocol under the supervision of a clinical psychologist, will interact with participants in the three intervention conditions via phone to personalise interventions, providing recommendations of certain modules through an orientation phone call which will take up to 90 minutes. Participants will be randomised to conditions. Cognitive Behavioural Therapy intervention (CBT-only). The CBT material will be delivered via email over 6 weeks. Emails will be delivered as follows: 5 in the first week, 4 in week 2, followed by 3 emails per week in weeks 3-6. The materials will cover a range of information and strategies for improving sleep and its daytime effects. The orientation phone call will take up to 60 minutes. Light & Dark Therapy intervention (LDT). Participants in this group will wear light therapy glasses for 20-30 minutes each morning for 6 weeks. Participants will be encouraged to continue using light therapy glasses until project completion in week 10. Light exposure strategies will be provided through an orientation phone call which will take up to 45 minutes. Participants will also be provided with a night light to use during nighttime awakenings (Dark Therapy). The LDT condition will also receive weekly emails during the active intervention phase (i.e. an email at the end of each week over 6 weeks) to serve as a review of LDT strategies. Emails will be very brief and are designed as reminders to use different strategies such as gaining bright light in the morning and using dim lights in the evening. Treatment adherence will be assessed for those in intervention conditions in the post-intervention (week 6) and follow-up (week 10) questionnaires. Participants will respond to how frequently they used (i.e., how many days in a typical week they have used strategies) different components of the intervention and how useful they found these. Email analytics will be used to supplement participants self-report information.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include (a) first-time mothers between four to twelve months postpartum; (b) aged 18 years or above; (c) singleton pregnancy; (d) ability to read and write in English; (e) regular access to phone, email and internet.
Exclusion criteria
Exclusion Criteria: • Currently pregnant. • Fixed night shiftwork between midnight and 5am, or rotating work schedules that require night shifts during project participation. • Insomnia Severity Index score of <8 at baseline. • Participants who show the following current symptoms of sleep disorders as (assessed using the Duke Structured Interview for Sleep Disorders; Edinger et al., 2009): • Sleep apnea: loud snoring OR observed gasping or pauses in breathing OR previously diagnosed with apnea hypopnea index >15 but not/inadequately treated. • Previously diagnosed Periodic Limb Movement Disorder with arousal index >15 and currently untreated. • Untreated Restless Legs Syndrome (RLS) occurring 3 times/week, with duration of at least one month. • Current circadian rhythm disorders including: • Irregular Sleep Wake Disorder. • Non-24-Hour Sleep-Wake Syndrome. • Advance Sleep-Phase Syndrome (if habitual bed time is earlier than 8pm and habitual wake time is earlier than 4am. Occasional deviation from this schedule is allowed). • Narcolepsy • Have unstable medical conditions that directly affect sleep. • Take medication that affects sleep (including sleep medications, melatonin, steroid inhalers, antidepressant medications, cannabis, etc.). • Report current Post-traumatic Stress Disorder, Panic Disorder (if > 4 times nocturnal in the past month), Bipolar Disorder, Psychotic disorders or Substance Use Disorders. Exclusion of those with current depression will only occur if risk issues are evident assessed during initial telephone interview – those with current suicidal ideation/self-harm behaviours or who pose a risk of harm to others will be excluded and referred to appropriate services. • Have infants with medical conditions that affect sleep. • Have been advised be health professionals to avoid exposure to bright light (including chronic migraines and eye conditions such as macular degeneration, eye diseases). • Expresses personal preference or concerns regarding exposure to bright light. • Suffer from epilepsy. • Reports on average, 3 or more infant awakenings per night over the past month requiring parental assistance to reinitiate sleep - Participants who pose a risk of harm to either themselves or to others will be excluded (assessed in a risk assessment during the telephone screening interview at baseline).
Outcome results
None listed