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Active, Not Recruiting

NCT Number: NCT05356364

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Insomnia Behavior Behavioral Symptoms Depression Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Medical Center

Novi, Michigan, 48377, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Cognitive Behavioral Therapy for insomnia (CBTi)

Behavioral

cognitive and behavioral treatment for perinatal insomnia.

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Behavioral

Mindfulness and behavioral based therapy for perinatal insomnia.

Primary outcomes

  1. Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.

    Time frame: The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.

    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.

  2. Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.

    Time frame: 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..

    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.

Secondary outcomes

  1. Comparative effectiveness between PUMAS and CBTI on acute depression effects.

    Time frame: The investigators will examine change in EPDS scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.

    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.

  2. Comparative effectiveness between PUMAS and CBTI on postpartum depression effects.

    Time frame: 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.

    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.

  3. Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.

    Time frame: The investigators will examine change in PSASC scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.

    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.

  4. Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Acronym: INSPIRE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 2, 2022
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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