Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
Completed · Not applicable
Conditions studied: Insomnia
In brief
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.
Key facts
- Study ID
- NCT04445805
- Run by
- Henry Ford Health System
- People needed
- 64
- Starts
- 2021-03-15
- Expected to finish
- 2023-12-31
- Last updated by the study team
- 2024-01-19
Who can join
Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
- (2) Insomnia Severity Index score > 10
- (3) age 18 - 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
You may not qualify if…
- High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age>40)
- Bipolar disorder (contraindicated for CBTI)
- Seizures (contraindicated for CBTI)
- Active suicidal intent
- Shift work
- Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.
Where it is running
- Henry Ford Medical Center — Novi, Michigan, United States
Full record on ClinicalTrials.gov
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