Clinical trial NCT05356364: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Official title: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Insomnia
Depression
Keywords: Pregnancy
Postpartum
Telemedicine
Cognitive arousal
Insomnia
Depression
Mindfulness
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nearly half of women develop insomnia during pregnancy, which is associated with increased risk for developing perinatal depression. The purpose of this research is to evaluate the implementability and effectiveness of a mindfulness-based therapy for insomnia relative to cognitive-behavioral therapy for insomnia in pregnant women with insomnia and comorbid depression. The investigators aim to examine whether a mindfulness-based intervention effectiveness reduces symptoms of insomnia and comorbid depression.

Detailed description: The investigators will conduct a pilot hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) wherein 100 pregnant women with DSM-5 insomnia disorder and comorbid depression (Edinburgh Postnatal Depression Scale ≥ 10) are randomized to a mindfulness-based intervention--Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)--or Cognitive Behavioral Therapy for Insomnia (CBTI). Patients will be recruited from women's health clinics across Henry Ford Health in Metro Detroit including underserved women, serving as real-world implementation. Per clinic operations since the pandemic, therapies will be via telemedicine to meet patient expectations. Study outcomes will be assessed before and after treatment, then across the first postpartum year.

Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy, gestational week 14-31.
2. DSM-5 Insomnia Disorder (acute or chronic).
3. Insomnia Severity Index (ISI) score ≥ 11.
4. Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10.
5. Ensure adequate sleep opportunity.
6. Age ≥ 18, English-speaking.
7. Reliable internet access (treatment, assessments)

Exclusion Criteria:

1. High risk pregnancy (age \>40y, pre-eclampsia, any condition deemed serious risk to mother/fetus; hypertension and diabetes allowed).
2. Active suicidal intent (ideation is allowed).
3. Night or rotating shift work.
4. Epworth Sleepiness Scale\>15 (Excessive sleepiness)
5. Health condition unsafe for sleep restriction (bipolar, epilepsy, etc.).

Primary outcomes:
measure: Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
timeFrame: The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
measure: Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.
timeFrame: The investigators will examine changes in ISI scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum..
Secondary outcomes:
measure: Comparative effectiveness between PUMAS and CBTI on acute depression effects.
timeFrame: The investigators will examine change in EPDS scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
measure: Comparative effectiveness between PUMAS and CBTI on postpartum depression effects.
timeFrame: The investigators will examine changes in EPDS scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.
measure: Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.
timeFrame: The investigators will examine change in PSASC scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
measure: Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.
timeFrame: The investigators will examine changes in PSASC scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.
Other outcomes:
Locations:
city: Novi
country: United States
facility: Henry Ford Medical Center
state: Michigan
Study officials:
References: