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

NCT05356364 | Active Not Recruiting

• 1 other identifier: R34MH130562
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Depression

Keywords

Pregnancy; Postpartum; Telemedicine; Cognitive arousal; Insomnia; Depression; Mindfulness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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 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 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 investigators will examine changes in PSASC scores across the first postnatal year, which will be assessed at 3, 6, 9, and 12 months postpartum.

Study Arms (2)

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

ACTIVE COMPARATOR

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)

Cognitive Behavioral Therapy for Insomnia (CBTI)

ACTIVE COMPARATOR

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)

Interventions

Cognitive Behavioral Therapy for Insomnia (CBTI) BEHAVIORAL

cognitive and behavioral treatment for perinatal insomnia.

Cognitive Behavioral Therapy for Insomnia (CBTI)

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) BEHAVIORAL

Mindfulness and behavioral based therapy for perinatal insomnia.

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only pregnant women are eligible to participate in this trial.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Medical Center

Novi, Michigan, 48377, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Depression

Interventions

Cognitive Behavioral Therapy; Sleep

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Scientist

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: May 2, 2022
• Study Start: February 1, 2023
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)