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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
114
Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.
Intervention based on improving assertive communication and regulating emotions.
Depression
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
Time frame: Follow up: 2 weeks post partum
Depression
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
Time frame: Follow up: 3 months post partum
Depression
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
Time frame: Follow up: 6 months post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Time frame: Follow up: 2 weeks post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Time frame: Follow up: 3 months post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Time frame: Follow up: 6 months post partum
Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)
sleep pattern derived from sleep diaries
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Time frame: Post intervention: after 5 weeks from the start of intervention
insomnia symptoms
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)
Time frame: Post intervention: after 5 weeks from the start of intervention
Emotion regulation
Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.
Time frame: Post intervention: after 5 weeks from the start of intervention