Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE) (INSPIRE)
Insomnia, Depression
About this trial
This is an interventional treatment trial for Insomnia focused on measuring Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness
Eligibility Criteria
Inclusion Criteria:
- Singleton pregnancy, gestational week 14-31.
- DSM-5 Insomnia Disorder (acute or chronic).
- Insomnia Severity Index (ISI) score ≥ 11.
- Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
- Ensure adequate sleep opportunity.
- Age ≥ 18, English-speaking.
- Reliable internet access (treatment, assessments)
Exclusion Criteria:
- High risk pregnancy (age >40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed).
- Active suicidal intent (ideation is allowed).
- Night or rotating shift work.
- Epworth Sleepiness Scale>15 (Excessive sleepiness)
- Health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).
Sites / Locations
- Henry Ford Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Cognitive Behavioral Therapy for Insomnia (CBTI)
PUMAS combines behavioral sleep strategies with elements from mindfulness-based interventions, and is tailored specifically to meet the unique needs of pregnant women. Behavioral sleep strategies include sleep restriction and stimulus control. Mindfulness elements include guided meditations and engaging in mindful activities. PUMAS consists of 6 60-minute sessions with a therapist along with self-monitoring with sleep diaries. All sessions are delivered via telemedicine during pregnancy.
CBTI combines behavioral sleep strategies with cognitive therapy. It is the first-line treatment for insomnia as recommended by the American College of Physicians and the American Academy of Sleep Medicine. Behavioral sleep strategies include sleep restriction and stimulus control. Cognitive therapy includes scheduled worry time and challenging dysfunctional beliefs about sleep. CBTI consists of 6 60-minute sessions with a therapist along with self-monitoring with sleep diaries. All sessions are delivered via telemedicine during pregnancy.