Efficacy of Digital CBT-I Intervention During Pregnancy

Not Applicable

• Conditions: Insomnia in Pregnancy
• Interventions: Behavioral: Assertive communication training; Behavioral: CBT-I

• 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

Arm && Interventions

Group	Intervention	Description
Assertive communication training	Assertive communication training	Five sessions composed of: psychoeducation and explanation of the importance of emotional and cognitive factors for good sleep. Psychoeducation about the concept of assertiveness, explanation of the passive, aggressive and assertive style; explanation and exercises regarding self-esteem and positive self-image; explanation of the development of sleep of the child in the first years of life; explanation and exercises on the phase of the management of feedback and requests; conflict management; relapses prevention.
CBT-I group	CBT-I	Five sessions composed of: psychoeducation on sleep change during pregnancy and postpartum; sleep hygiene principles; stimulus control technique, sleep restriction technique (f this technique will be too difficult for the participants to be apply, a replacement and less disabling technique will be applied: sleep compression); psychoeducation on the child's sleep at birth and on the change in the sleep-wake cycle in the early stages of the child's life; cognitive control technique; cognitive reconstruction technique and de-catastrophization; relapses prevention.

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.