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

Depression Clinical Trial

— INSPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356364
• Other study ID #: R34MH130562
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Henry Ford Health System
• Contact: Nancy Hay
• Phone: 313-874-4386
• Email: nhay[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Depression
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBTI)
cognitive and behavioral treatment for perinatal insomnia.
• Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Mindfulness and behavioral based therapy for perinatal insomnia.

Locations

Country	Name	City	State
United States	Henry Ford Medical Center	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.