Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

University of Calgary

Status: Completed

Conditions: Insomnia; Sleep Disturbance

Treatments: Behavioral: Cognitive Behavioural Therapy for Insomnia; Other: Active Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03918057

REB19-0465

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Cognitive-Behavioural Therapy Group

Experimental group

Description:

Participants receive 5 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.

Treatment:

Behavioral: Cognitive Behavioural Therapy for Insomnia

Treatment as Usual Group

Active Comparator group

Description:

Participants receive usual obstetric care and are placed on a wait-list until six months postpartum. All activities or efforts participants make to treat or improve their sleep on their own is recorded and coded. After the final assessment six months postpartum, participants have the option of receiving 1.5-hour sessions (for a total of 5 session) of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.

Treatment:

Other: Active Control