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

A Randomized Controlled Trial Examining the Impact of a Brief, Proactive, Cognitive Behavioural Therapy Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Disturbance; Perinatal Depression; Perinatal Anxiety
• Intervention / Treatment: Behavioral: Sleep Hygiene Workshop; Behavioral: Cognitive Behavioural Therapy for Insomnia Workshop

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheryl Green, C.Psych; Phone Number: 33672 905-522-1155; Email: sgreen@stjoes.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. ≥18 years
2. First or second trimester of pregnancy (prior to 27 weeks gestation) to allow for early/proactive benefit of sleep intervention.
3. Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index)
4. Fluent in English.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sleep Hygiene Workshop; 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; 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
EXPERIMENTAL: Cognitive Behavioural Therapy for Insomnia Workshop; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA).	The STICSA is a 21-item self-report scale that assesses cognitive and somatic components of anxiety. The STICSA is comprised of a state scale that measures individuals' current anxiety symptoms, and a trait scale that assesses one's proneness to anxiety, more generally. In the present study, only the trait scale of the STICSA will be used. Items are scored on a 4-point scale ranging from 1 ('not at all') to 4 ('very much so'). The STICSA has demonstrated excellent validity and reliability. A cut-off score of 43 or higher on the STICSA has been suggested for detecting a probable anxiety disorder. The STICSA has been validated for use in clinical samples of adults with anxiety disorders, although not explicitly in perinatal samples.	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)	The EPDS is a 10-item self-report measure that assesses symptoms of depression during the perinatal period. Items are scored on a 4-point scale ranging from 0 to 3, with higher scores reflecting greater depressive symptomatology. The EPDS has demonstrated good sensitivity and specificity for a diagnosis of Major Depressive Disorder (MDD). Cut-off scores of 15 and 13 or higher have been suggested for detecting a probable diagnosis of MDD during pregnancy and the postpartum period, respectively.	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)	The DERS is a 36-item self-report scale designed to assess difficulties with emotion regulation. The DERS contains six subscales that measure: non-acceptance goals, impulse, awareness, strategies, and clarity. Items are rated on a 5-point Likert scale, ranging from 1 (almost never, 0-10%) to 5 (almost always, 91-100%), with higher scores reflecting greater difficulties regulating emotions. The DERS has demonstrated good internal consistency (α=0.86) and test-retest reliability (0.74).	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)	The GAD-7 is a 7-item self-report measure that assesses anxiety symptom severity over a previous two-week period. Items are measured on a 4-point scale ranging from 0 ('not at all') to 3 ('nearly every day'). A cut-off score of 10 or higher with sensitivity of 89% and specificity of 82% has been suggested for detecting a probable diagnosis of Generalized Anxiety Disorder. The GAD-7 has also been validated for use in perinatal samples.	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)	The PSWQ is a 16-item self-report measure that assesses the tendency to worry. Items are scored on a 5-point scale ranging from 1 ('not typical at all') to 5 ('very typical'), with higher scores reflecting greater pathological worry. A cut-off score of 62 or higher has been suggested for determining a probable GAD diagnosis. The PSWQ has demonstrated excellent internal consistency and validity across various populations and has been validated for use in perinatal samples.	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.
Pre-Sleep Arousal Scale (PSAS)	The PSAS is a 16-item self-report measure that assesses one's state of arousal as they fall asleep. The measure consists of two subscales, one intended to measure cognitive arousal and the other somatic arousal. Participants are asked to describe how intensely they generally experience each cognitive and somatic symptom as they attempt to fall asleep in their own bedroom. Items are scored on a 5-point scale from 1 ('not at all') to 5 ('extremely), with subscale scores ranging from 8-40. Higher scores represent greater pre-sleep arousal.	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.
PROMIS Anxiety Short-Form (PROMIS-A-SF)	The PROMIS Anxiety Short-Form is an 8-item self-report measure designed to assess anxious apprehension and hyperarousal. Participants rated the frequency of their symptoms on a 5-point scale ranging from 1 ('not at all') to 5 ('very much'), with higher scores representing greater anxiety. The measure was adapted to assess the frequency of symptoms in the past day rather than the past 7 days as used previously. The PROMIS Anxiety Short-Form has demonstrated good internal consistency (Cronbach's α = .93) and 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.
PROMIS Depression Short-Form (PROMIS-D-SF)	The PROMIS Depression Short-Form is an 8-item self-report measure that assesses negative mood and negative views of self. Participants rated the frequency of their symptoms on a 5-point scale ranging from 1 ('not at all') to 5 ('very much'), with higher scores representing greater depression. The measure was adapted to assess the frequency of symptoms in the past day rather than the past 7 days as used previously. The PROMIS Depression Short-Form has demonstrated good internal consistency (Cronbach's α = .95) and 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.
Consensus Sleep Diary (CSD).	The CSD was developed by a committee of experts with the aim of proposing a new improved and standardized sleep diary. This sleep diary will be filled out in the morning and includes questions such as (a) what time the participant went to bed, (b) what time they intended to sleep, (c) how long they were awake during the night, (d) what time they woke for the final time, (e) what time they got out of bed, and (f) how much sleep the participant got that night. From this data, we will derive time in bed, sleep onset latency, wakefulness after sleep onset, total sleep time, and sleep efficiency.	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.
Polysomnography (PSG).	PSG recordings will be obtained using a device recording system that is self-applied at home. Portable PSG devices are primarily used for the screening of obstructive sleep apnea and growing research supports their use to evaluate sleep architecture and sleep quality. Standard recommendations suggest using PSG as a quantitative dependent measure in sleep research. Following these recommendations, PSG will be used for 2 nights to identify and quantify sleep-related breathing disturbances, periodic limb movements during sleep, and derive sleep measures (e.g., sleep onset latency, wakefulness after sleep onset, number of awakenings, total sleep time, terminal wakefulness, sleep efficiency).	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.
Actigraphy watches.	Actigraphy watches are wrist-worn and battery-operated activity monitors that look similar to a small wristwatch. These devices are used to measure sleep and activity patterns and are typically used as an adjunctive measure in the diagnosis and treatment of insomnia to improve the reliability of self-report estimates of sleep. In this study, data collected from the actigraphy watches will be used to calculate objective measures of sleep such as sleep efficiency, total sleep time, time in bed, sleep onset latency, number of awakenings during the night, time awake after sleep onset, and terminal wakefulness.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sociodemographic Factors	Sociodemographic information collected will include participant's gender, age, ethnicity, marital status, education level, income level, parity, medical and delivery history, family psychiatric history, medication usage, and treatment history.	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.

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 1, 2023
• Primary Completion (ANTICIPATED): September 1, 2024
• Study Completion (ANTICIPATED): September 1, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: January 26, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: CBTI-SleepHygiene-RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No