Efficacy of Digital CBT-I Intervention During Pregnancy

Not Applicable

• Conditions: Insomnia in Pregnancy

• Registration Number: NCT04350333
• Lead Sponsor: University of Rome G. Marconi

Brief Summary

This randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy for Insomnia in pregnant women. Particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. The experimental intervention is a digital CBT-I and the control intervention group is an assertive communication training. Both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. Furthermore, both interventions protocol include a baseline, half time and follow up assessments.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-06
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-17
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-27
• Study Start: 2021-05-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 114

Inclusion Criteria

• Healthy pregnancy
• Women that not consume nicotine or alcool
• BMI < 30
• Women who complains of insomnia or bad sleep quality

Exclusion Criteria

• BMI> 30
• Complicated pregnancy
• Women who consume nicotine or alcool

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety	Follow up: 6 months post partum	Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Depression	Follow up: 6 months post partum	Depression symptomatology (Edinburgh Postnatal Depression Scale - EPDS). Scoring: \< 8: depression not likely; 9-11: depression possible; 12-13:Fairly high possibility of depression; \> 14 probable depression

Secondary Outcome Measures

Name	Time	Method
Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)	Post intervention: after 5 weeks from the start of intervention	sleep pattern derived from sleep diaries
insomnia symptoms	Post intervention: after 5 weeks from the start of intervention	Insomnia severity index scores (ISI). Scoring: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
Emotion regulation	Post intervention: after 5 weeks from the start of intervention	Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.