Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

NCT05710991 | Recruiting

• 1 other identifier: CBTI-SleepHygiene-RCT
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. Research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. Currently, there are two main non-medical treatments for sleep difficulties available. The first, cognitive behavioural therapy (CBT), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. In addition, shortened sessions of CBT for insomnia have also been found to successfully reduce sleep difficulties. The second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. The present study will compare the effectiveness of a CBT for insomnia group workshop to a Sleep Hygiene group workshop.

Conditions

Sleep Disturbance; Perinatal Anxiety; Perinatal Depression

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI)

  The ISI is a 7-item self-report questionnaire that assesses the nature, severity, and impact of insomnia. Items are scored on a 5-point Likert scale ranging from 0 ('no problem') to 4 ('very severe problem') with higher scores reflecting greater insomnia severity. Total scores between 0-7 indicate an absence of insomnia; scores between 8-14 suggest sub-threshold insomnia; scores between 15-21 indicate moderate insomnia; and scores between 22-28 suggest severe insomnia. The ISI has demonstrated good psychometric properties.

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

Secondary Outcomes (11)

• State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA).

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

• Edinburgh Postnatal Depression Scale (EPDS)

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

• Difficulties in Emotion Regulation Scale (DERS)

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

• Generalized Anxiety Disorder 7-Item Scale (GAD-7)

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

• Penn State Worry Questionnaire (PSWQ)

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

Other Outcomes (1)

• Sociodemographic Factors

  Throughout the duration of the study (average of 10 months), change will be assessed at three timepoints: pre-treatment baseline (prior to 26 weeks gestation), post-treatment (up to 34 weeks gestation), and again at 12 weeks postpartum.

Study Arms (2)

Sleep Hygiene Workshop

ACTIVE COMPARATOR

The Sleep Hygiene workshop contains psychoeducation on sleep hygiene and has been modified to target the transitions and concerns faced by perinatal individuals. Sleep hygiene is commonly utilized as a treatment for insomnia in general practice, with the information provided through verbal advice and a sleep hygiene info sheet. As such, the sleep hygiene protocol used in this study reflects standard care commonly offered to perinatal individuals outside of our specialized clinic.

Behavioral: Sleep Hygiene Workshop

Cognitive Behavioural Therapy for Insomnia Workshop

EXPERIMENTAL

The Cognitive Behavioural Therapy (CBT) for Insomnia workshop contains empirically supported strategies for insomnia that have been modified to target the transitions and concerns faced by perinatal individuals. CBT is the first-line treatment for insomnia and promising research on CBT for insomnia specifically during pregnancy and postpartum is emerging.

Behavioral: Cognitive Behavioural Therapy for Insomnia Workshop

Interventions

Sleep Hygiene Workshop BEHAVIORAL

Psychoeducation on the perinatal period and sleep difficulties including principles of sleep hygiene conducive environment for sleep, bedtime routine, food, beverage, and stimulant consumption, exercise

Sleep Hygiene Workshop

Cognitive Behavioural Therapy for Insomnia Workshop BEHAVIORAL

The CBT-I workshop group contains empirically supported strategies for insomnia modified to target the transitions and concerns faced by perinatal individuals. Content includes Sleep drive, stimulus control, sleep restriction, counter-arousal techniques, cognitive restructuring

Cognitive Behavioural Therapy for Insomnia Workshop

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥18 years
• First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention.
• Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)
• Fluent in English.

You may not qualify if:

• Severe depression/active suicidal ideation or psychotic
• Unstable general medical condition
• Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration
• a sleep disorder other than insomnia (e.g., restless leg syndrome).

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton, West 5th Campus

Hamilton, Ontario, L9C 0E3, Canada

RECRUITING

MeSH Terms

Conditions

Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sheryl Green, C.Psych

CONTACT

905-522-1155; sgreen@stjoes.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Clinical Psychologist

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 2, 2023
• Study Start: August 10, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)