Sleeping For Two: Trial for CBT for Insomnia in Pregnancy
Condition: Insomnia; Sleep Disturbance
MeSH terms: Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioural Therapy for Insomnia; Active Control
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Specifically, this therapy provides psychoeducation about thoughts contributing to the maintenance of sleep problems, and instruction in behavioural techniques to help decrease sleep onset latency and promote effective sleep maintenance.; Participants will receive regular obstetric care and will be placed on a wait-list for CBT-I treatment after their final assessment. All activities women try for improving their own sleep problems between assessments will be recorded and coded for.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment