Insomnia in Pregnancy
Conditions
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.
Interventions
BEHAVIORALCBT-I
Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.
BEHAVIORALAssertive communication training
Intervention based on improving assertive communication and regulating emotions.
Sponsors
University of Rome G. Marconi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression | Follow up: 2 weeks 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 |
| Anxiety | Follow up: 2 weeks post partum | Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Outcome results
None listed