Insomnia in PregnancyNCT04350333
Efficacy of Digital CBT-I Intervention During Pregnancy
A study testing CBT-I and Assertive communication training in people with Insomnia in Pregnancy, run by University of Rome G. Marconi.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insomnia in Pregnancy
- What is being tested?
- CBT-I and Assertive communication training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pregnancy
- Women that not consume nicotine or alcool
- BMI < 30
- Women who complains of insomnia or bad sleep quality
Who cannot join
- BMI> 30
- Complicated pregnancy
- Women who consume nicotine or alcool
About this study
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
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
- Being tested
- CBT-I, Assertive communication training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT-IBehavioural
Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.
Assertive communication trainingBehavioural
Intervention based on improving assertive communication and regulating emotions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Assertive communication training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Follow up: 6 months post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Measured: Follow up: 2 weeks post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Measured: Follow up: 3 months post partum
Anxiety
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Measured: Follow up: 6 months post partum
Secondary outcomes (3)
Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)
sleep pattern derived from sleep diaries
Measured: 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)
Measured: Post intervention: after 5 weeks from the start of intervention
Emotion regulation
Emotion Regulation Questionnaire (ERQ) - Higher scores mean better outcome.
Measured: Post intervention: after 5 weeks from the start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome G. Marconi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Bacaro, University of Rome G. Marconi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04350333
- Sponsor's protocol ID
- UMarconi
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04350333
- Acronym / sponsor ID
- UMarconi
- Conditions
- Insomnia in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of Rome G. MarconiUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-I group | Experimental | Behavioral: CBT-IFive 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. |
| Assertive communication training | Active comparator | Behavioral: Assertive communication trainingFive 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. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy pregnancy
- Women that not consume nicotine or alcool
- BMI < 30
- Women who complains of insomnia or bad sleep quality
Key exclusion criteria (3 listed)
- BMI> 30
- Complicated pregnancy
- Women who consume nicotine or alcool
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT-IStrategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc. | Behavioural | CBT-I group |
| Assertive communication trainingIntervention based on improving assertive communication and regulating emotions. | Behavioural | Assertive communication training |
Primary outcome
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
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
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
Anxiety
Time frame: Follow up: 2 weeks post partum
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Anxiety
Time frame: Follow up: 3 months post partum
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
Anxiety
Time frame: Follow up: 6 months post partum
Anxiety symptomatology (State-trait anxiety inventory - STAI-Y). Higher scores mean a worse outcome.
3 secondary outcomes
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
insomnia symptoms
Time frame: Post intervention: after 5 weeks from the start of intervention
Emotion regulation
Time frame: Post intervention: after 5 weeks from the start of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing CBT-I and Assertive communication training in people with Insomnia in Pregnancy, run by University of Rome G. Marconi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Follow up: 2 weeks post partum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.