Efficacy of Digital CBT-I Intervention During Pregnancy

NCT04350333 | Unknown DMC

• 1 other identifier: UMarconi
• Study Type: interventional
• Target: 114
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia in Pregnancy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)

  Post intervention: after 5 weeks from the start of intervention

• insomnia symptoms

  Post intervention: after 5 weeks from the start of intervention

• Emotion regulation

  Post intervention: after 5 weeks from the start of intervention

Study Arms (2)

CBT-I group

EXPERIMENTAL

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

Assertive communication training

ACTIVE COMPARATOR

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

Interventions

CBT-I BEHAVIORAL

Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.

CBT-I group

Assertive communication training BEHAVIORAL

Intervention based on improving assertive communication and regulating emotions.

Assertive communication training

Eligibility Criteria

• Age: 19 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy pregnancy
• Women that not consume nicotine or alcool
• BMI \< 30
• Women who complains of insomnia or bad sleep quality

You may not qualify if:

• BMI\> 30
• Complicated pregnancy
• Women who consume nicotine or alcool

Sponsors & Collaborators

• University of Rome G. Marconi: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 17, 2020
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04