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Efficacy of Digital CBT-I Intervention During Pregnancy

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ClinicalTrials.gov Identifier: NCT04350333
Recruitment Status : Not yet recruiting
First Posted : April 17, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Valeria Bacaro, University of Rome G. Marconi

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.

Condition or disease Intervention/treatment Phase
Insomnia in Pregnancy Behavioral: CBT-I Behavioral: Assertive communication training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

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.




Primary Outcome Measures :
  1. Depression [ Time Frame: 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

  2. Depression [ Time Frame: Follow up: 3 months 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

  3. Depression [ Time Frame: Follow up: 6 months 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

  4. Anxiety [ Time Frame: Follow up: 2 weeks post partum ]
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.

  5. Anxiety [ Time Frame: Follow up: 3 months post partum ]
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.

  6. Anxiety [ Time Frame: Follow up: 6 months post partum ]
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.


Secondary Outcome Measures :
  1. Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency) [ Time Frame: Post intervention: after 5 weeks from the start of intervention ]
    sleep pattern derived from sleep diaries

  2. insomnia symptoms [ Time Frame: 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)

  3. Emotion regulation [ Time Frame: Post intervention: after 5 weeks from the start of intervention ]
    Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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
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Responsible Party: Valeria Bacaro, Principal Investigator, University of Rome G. Marconi
ClinicalTrials.gov Identifier: NCT04350333    
Other Study ID Numbers: UMarconi
First Posted: April 17, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders