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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorSt. Joseph's Healthcare Hamilton

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Sleep Hygiene WorkshopActive comparator 1 intervention
Group B: Cognitive Behavioural Therapy for Insomnia WorkshopExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
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

1

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.

Time frame
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.
2

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.

Time frame
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.
3

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).

Time frame
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.
4

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.

Time frame
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

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.

Time frame
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.

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