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

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 Overview

• Status: Not yet recruiting
• Conditions: Insomnia in Pregnancy
• Intervention / Treatment: Behavioral: CBT-I; Behavioral: Assertive communication training

• Study Type: Interventional
• Enrollment (Anticipated): 114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Rome G. Marconi

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 6, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UMarconi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No