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

NCT ID: NCT05356364

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-04-30

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.

Conditions

Insomnia; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

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.

Group Type: ACTIVE_COMPARATOR

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Intervention Type: BEHAVIORAL

Mindfulness and behavioral based therapy for perinatal insomnia.

Cognitive Behavioral Therapy for Insomnia (CBTI)

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBTI)

Intervention Type: BEHAVIORAL

cognitive and behavioral treatment for perinatal insomnia.

Interventions

Cognitive Behavioral Therapy for Insomnia (CBTI)

cognitive and behavioral treatment for perinatal insomnia.

Intervention Type: BEHAVIORAL

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Mindfulness and behavioral based therapy for perinatal insomnia.

Intervention Type: BEHAVIORAL

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

David Kalmbach

Assistant Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Henry Ford Medical Center

Novi, Michigan, United States

Countries

United States

Other Identifiers

R34MH130562

Identifier Type: NIH

Identifier Source: org_study_id

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