Efficacy of Digital CBT-I Intervention During Pregnancy

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial

Conditions
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Insomnia in Pregnancy

Intervention / Treatment
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* Behavioral: CBT-I
* Behavioral: Assertive communication training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-I group<br>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. | Behavioral: CBT-I<br>* Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.<br>|
| Active Comparator: Assertive communication training<br>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. | Behavioral: Assertive communication training<br>* Intervention based on improving assertive communication and regulating emotions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Follow up: 6 months post partum | 
| Anxiety | Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome. | Follow up: 2 weeks post partum | 
| Anxiety | Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome. | Follow up: 3 months post partum | 
| Anxiety | Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome. | Follow up: 6 months post partum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency) | sleep pattern derived from sleep diaries | 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) | Post intervention: after 5 weeks from the start of intervention | 
| Emotion regulation | Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome. | Post intervention: after 5 weeks from the start of intervention |