Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)

Conditions
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Insomnia, Depression

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)
* Behavioral: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)<br>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. | Behavioral: Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)<br>* Mindfulness and behavioral based therapy for perinatal insomnia.<br>|
| Active Comparator: Cognitive Behavioral Therapy for Insomnia (CBTI)<br>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. | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)<br>* cognitive and behavioral treatment for perinatal insomnia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative effectiveness between PUMAS and CBTI on acute insomnia effects. | The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated in a perinatal sample. The ISI scores range from 0-28 with higher scores indicating greater insomnia severity. | The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline. | 
| Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects. | The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated in a perinatal sample. The ISI scores range from 0-28 with higher scores indicating greater insomnia severity. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparative effectiveness between PUMAS and CBTI on acute depression effects. | The Edinburgh Postnatal Depression Scale (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in clinical trials. The EPDS scores range from 0-30 with higher scores indicating greater depression severity. | The investigators will examine change in EPDS scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline. | 
| Comparative effectiveness between PUMAS and CBTI on postpartum depression effects. | The Edinburgh Postnatal Depression Scale (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in clinical trials. The EPDS scores range from 0-30 with higher scores indicating greater depression severity. | 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. | 
| Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects. | The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in the perinatal population. Scores range form 8-40 with higher scores indicating greater nighttime cognitive arousal. | The investigators will examine change in PSASC scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline. | 
| Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects. | The Pre-Sleep Arousal Scale's Cognitive factor (PSASC) is a self-report measure of nocturnal cognitive arousal that has been validated in the perinatal population. Scores range form 8-40 with higher scores indicating greater nighttime cognitive arousal. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness