Trials / Unknown
UnknownNCT04350333
Efficacy of Digital CBT-I Intervention During Pregnancy
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 114 (estimated)
- Sponsor
- University of Rome G. Marconi · Academic / Other
- Sex
- Female
- Age
- 19 Years – 40 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CBT-I | Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc. |
| BEHAVIORAL | Assertive communication training | Intervention based on improving assertive communication and regulating emotions. |
Timeline
- Start date
- 2021-05-01
- Primary completion
- 2021-12-31
- Completion
- 2021-12-31
- First posted
- 2020-04-17
- Last updated
- 2021-04-27
Source: ClinicalTrials.gov record NCT04350333. Inclusion in this directory is not an endorsement.