Clinical trial NCT03918057: Sleeping For Two: Trial for CBT for Insomnia in Pregnancy
Official title: A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Disturbance
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-04-17
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.

Detailed description: Sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.Treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk.

A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.

Research Question and Objectives:

The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.

The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The investigators hypothesize that participants who receive a 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.

Eligibility criteria: Inclusion Criteria:

* At or over the age of 18
* Between 12 and 28 weeks pregnant
* Are able to read, write and speak in English
* Have a diagnosis of insomnia according to the DSM-V criteria.

Exclusion Criteria:

* Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome \[RLS\], sleep-disordered breathing \[SDB\]
* Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia)
* Active suicidal ideation
* Currently taking prescribed medications for sleep problems
* Smoking, drinking alcohol or drug abuse during pregnancy
* Being pregnant with multiples
* Diagnosis of chronic pain.

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.
measure: Pittsburgh Sleep Quality Index
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.
measure: Actigraphy (Actiwatch II, Phillips, USA) - Circadian rhythm amplitude, acrophase, mesor
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Actigraphy (Actiwatch II, Phillips, USA) - Total sleep time
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Actigraphy (Actiwatch II, Phillips, USA) - Number and frequency of awakenings
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Sleep Logs - Latency
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Sleep Logs - Total sleep time
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
measure: Sleep Logs - Number and frequency of awakenings
timeFrame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MacKinnon AL, Madsen JW, Dhillon A, Keys E, Giesbrecht GF, Williamson T, Metcalfe A, Campbell T, Mrklas KJ, Tomfohr-Madsen L. Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. Trials. 2021 Aug 12;22(1):532. doi: 10.1186/s13063-021-05498-w.