Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

NCT02295345 | Completed

• 1 other identifier: REB14-0356
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (4)

• Change in Actigraphy indices from baseline to post-treatment

  Actigraphy is recommended as a reliable and useful method of objective sleep assessment, providing information about indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings

  Baseline (Week 1), Post-treatment (Week 7)

• Change in Sleep Diary variables from baseline to post-treatment

  Participants complete a daily, standardized sleep diary on a weekly basis both during the treatment period, and at baseline and final assessment times to corroborate actigraphy data. Dependent variables derived from this data include total sleep time, time in bed, sleep efficiency, and sleep quality

  Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)

• Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment

  The ISI can be used to assess the severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and one's perceived distress caused by sleep problems. Scores on the ISI range from 0 to 28, with scores ≥ 15 indicating clinical insomnia.

  Baseline (Week 1), Post-treatment (Week 7)

• Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment

  The PSQI instrument is used in assessing one's sleep quality in the preceding month. It is comprised of 19 self-rated items and 5 questions rated by the roommate or bed partner. The PSQI possesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. PSQI scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.

  Baseline (Week 1), Post-treatment (Week 7)

Secondary Outcomes (1)

• Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment

  Baseline (Week 1), Post-treatment (Week 7)

Study Arms (1)

CBT for Insomnia

EXPERIMENTAL

Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.

Other: Cognitive Behavioural Therapy for Insomnia

Interventions

Cognitive Behavioural Therapy for Insomnia OTHER

CBT for Insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking women
• Over the age of 18
• Between twelve and twenty-eight weeks of gestation
• Identify as experiencing sleep disturbances will be recruited.

You may not qualify if:

• Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
• Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
• Currently taking prescribed medications for sleep problems
• Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
• Smoking, drinking alcohol or drug use during pregnancy.

Sponsors & Collaborators

• University of Calgary: lead
• University of Alberta: collaborator

Study Sites (1)

University Of Calgary

Calgary, Alberta, T2N1N4, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lianne Tomfohr-Madsen, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychology

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: November 20, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: September 17, 2018

Record last verified: 2018-09

Locations

CA (1)