Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia in Pregnancy
- Sponsor
- University of Rome G. Marconi
- Enrollment
- 114
- Primary Endpoint
- Anxiety
- Last Updated
- 5 years ago
Overview
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.
Investigators
Valeria Bacaro
Principal Investigator
University of Rome G. Marconi
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
- •Complicated pregnancy
- •Women who consume nicotine or alcool
Outcomes
Primary Outcomes
Anxiety
Time Frame: Follow up: 6 months post partum
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Depression
Time Frame: 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 Outcomes
- Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)(Post intervention: after 5 weeks from the start of intervention)
- insomnia symptoms(Post intervention: after 5 weeks from the start of intervention)
- Emotion regulation(Post intervention: after 5 weeks from the start of intervention)