Efficacy of Digital CBT-I Intervention During Pregnancy

NCT ID: NCT04350333

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-12-31

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.

Conditions

Insomnia in Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CBT-I group

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.

Group Type: EXPERIMENTAL

CBT-I

Intervention Type: BEHAVIORAL

Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.

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.

Group Type: ACTIVE_COMPARATOR

Assertive communication training

Intervention Type: BEHAVIORAL

Intervention based on improving assertive communication and regulating emotions.

Interventions

CBT-I

Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.

Intervention Type: BEHAVIORAL

Assertive communication training

Intervention based on improving assertive communication and regulating emotions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rome G. Marconi

OTHER

Sponsor Role: lead

Responsible Party

Valeria Bacaro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UMarconi

Identifier Type: -

Identifier Source: org_study_id