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Cognitive Behavioural Therapy vs Sleep Hygiene for Sleep Disorders

N/A

Recruiting

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years

Be between 18 and 65 years old

Must not have

A sleep disorder other than insomnia (e.g., restless leg syndrome)

Unstable general medical condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two treatments for sleep difficulties in pregnant and postpartum individuals - cognitive behavioural therapy (CBT) and sleep hygiene education. Previous research shows that CBT has successfully treated insomnia during

Who is the study for?

This trial is for English-speaking pregnant individuals in their first or second trimester who are experiencing sleep difficulties, as indicated by a score of 8 or higher on the Insomnia Severity Index. It aims to provide early and proactive non-medication-based treatment for insomnia.

What is being tested?

The study compares two non-medical treatments: a group workshop on Cognitive Behavioural Therapy (CBT) for insomnia, which has been successful in treating pregnancy-related sleep issues, versus a Sleep Hygiene education workshop that's commonly offered to improve sleep problems.

What are the potential side effects?

Since both interventions involve behavioral therapy and education without medication, side effects are minimal but may include discomfort from discussing personal issues or changes in routine due to implementing new sleep strategies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a sleep disorder that is not insomnia.

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My health condition is currently unstable.

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I do not have severe depression or thoughts of harming myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI)

Secondary study objectives

Actigraphy watches.

Consensus Sleep Diary (CSD).

Difficulties in Emotion Regulation Scale (DERS)

+8 more

Other study objectives

Sociodemographic Factors

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Behavioural Therapy for Insomnia WorkshopExperimental Treatment1 Intervention

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.

Group II: Sleep Hygiene WorkshopActive Control1 Intervention

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.

0 / 4Eligibility criteria met