Efficacy of Digital CBT-I Intervention During Pregnancy

University of Rome G. Marconi

Status: Unknown

Conditions: Insomnia in Pregnancy

Treatments: Behavioral: Assertive communication training; Behavioral: CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT04350333

UMarconi

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

114 participants in 2 patient groups

CBT-I group

Experimental group

Description:

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.

Treatment:

Behavioral: CBT-I

Assertive communication training

Active Comparator group

Description:

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.

Treatment:

Behavioral: Assertive communication training