search
Back to results

Efficacy of Digital CBT-I Intervention During Pregnancy

Primary Purpose

Insomnia in Pregnancy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CBT-I
Assertive communication training
Sponsored by
University of Rome G. Marconi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insomnia in Pregnancy

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    CBT-I group

    Assertive communication training

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    Anxiety
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
    Anxiety
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
    Anxiety
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.

    Secondary Outcome Measures

    Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)
    sleep pattern derived from sleep diaries
    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)
    Emotion regulation
    Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.

    Full Information

    First Posted
    April 6, 2020
    Last Updated
    April 26, 2021
    Sponsor
    University of Rome G. Marconi
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04350333
    Brief Title
    Efficacy of Digital CBT-I Intervention During Pregnancy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    December 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Rome G. Marconi

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia in Pregnancy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    114 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CBT-I group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Assertive communication training
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    CBT-I
    Intervention Description
    Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Assertive communication training
    Intervention Description
    Intervention based on improving assertive communication and regulating emotions.
    Primary Outcome Measure Information:
    Title
    Depression
    Description
    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
    Title
    Depression
    Description
    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
    Title
    Depression
    Description
    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
    Title
    Anxiety
    Description
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
    Time Frame
    Follow up: 2 weeks post partum
    Title
    Anxiety
    Description
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
    Time Frame
    Follow up: 3 months post partum
    Title
    Anxiety
    Description
    Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
    Time Frame
    Follow up: 6 months post partum
    Secondary Outcome Measure Information:
    Title
    Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)
    Description
    sleep pattern derived from sleep diaries
    Time Frame
    Post intervention: after 5 weeks from the start of intervention
    Title
    insomnia symptoms
    Description
    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
    Title
    Emotion regulation
    Description
    Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.
    Time Frame
    Post intervention: after 5 weeks from the start of intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Efficacy of Digital CBT-I Intervention During Pregnancy

    We'll reach out to this number within 24 hrs