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

Primary Purpose

Insomnia, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBTI)
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.).

Sites / Locations

  • Henry Ford Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)

Cognitive Behavioral Therapy for Insomnia (CBTI)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 24, 2022
Last Updated
February 2, 2023
Sponsor
Henry Ford Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05356364
Brief Title
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Acronym
INSPIRE
Official Title
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 31, 2025 (Anticipated)
Study Completion Date
August 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Depression
Keywords
Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Cognitive Behavioral Therapy for Insomnia (CBTI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBTI)
Intervention Description
cognitive and behavioral treatment for perinatal insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
Intervention Description
Mindfulness and behavioral based therapy for perinatal insomnia.
Primary Outcome Measure Information:
Title
Comparative effectiveness between PUMAS and CBTI on acute insomnia effects.
Description
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.
Time Frame
The investigators will examine change in ISI scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
Title
Comparative effectiveness between PUMAS and CBTI on postpartum insomnia effects.
Description
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.
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..
Secondary Outcome Measure Information:
Title
Comparative effectiveness between PUMAS and CBTI on acute depression effects.
Description
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.
Time Frame
The investigators will examine change in EPDS scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
Title
Comparative effectiveness between PUMAS and CBTI on postpartum depression effects.
Description
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.
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.
Title
Comparative effectiveness between PUMAS and CBTI on acute cognitive arousal effects.
Description
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.
Time Frame
The investigators will examine change in PSASC scores from Pretreatment Baseline to Posttreatment, the latter will occur 6-9 weeks after Baseline.
Title
Comparative effectiveness between PUMAS and CBTI on postpartum cognitive arousal effects.
Description
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.
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.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Only pregnant women are eligible to participate in this trial.
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Hay
Phone
313-874-4386
Email
nhay@hfhs.org
First Name & Middle Initial & Last Name or Official Title & Degree
David Kalmbach, PhD
Phone
313-433-4553
Email
dkalmba1@hfhs.org
Facility Information:
Facility Name
Henry Ford Medical Center
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Kalmbach, PhD
Phone
248-325-3938
Email
dkalmbach1@hfhs.org
First Name & Middle Initial & Last Name & Degree
Cynthia Fellman-Couture, PhD, RN
Phone
248-344-7362
Email
cfellma1@hfhs.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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