InsomniaINSPIRENCT05356364
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
A study testing Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) in people with Insomnia and Depression, run by Henry Ford Health System at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Insomnia, Depression
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBTI), Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)
- Keywords
- Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBTI)Behavioural
cognitive and behavioral treatment for perinatal insomnia.
Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)Behavioural
Mindfulness and behavioral based therapy for perinatal insomnia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Feb 2023
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kalmbach, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356364
- Sponsor's protocol ID
- R34MH130562
- Acronym
- INSPIRE
- Status last verified
- Sep 2026
- First submitted
- 24 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Negative Stressful Perseverations in Insomnia to Revitalize Expecting Moms (INSPIRE)
- ClinicalTrials.gov ID
- NCT05356364
- Acronym / sponsor ID
- INSPIRE / R34MH130562
- Conditions
- Insomnia, Depression
- Keywords
- Pregnancy, Postpartum, Telemedicine, Cognitive arousal, Insomnia, Depression, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) | Active comparator | Behavioral: 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. |
| Cognitive Behavioral Therapy for Insomnia (CBTI) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBTI)cognitive and behavioral treatment for perinatal insomnia. | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBTI) |
| Perinatal Understanding of Mindful Awareness for Sleep (PUMAS)Mindfulness and behavioral based therapy for perinatal insomnia. | Behavioural | Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) |
Primary outcome
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.
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal Understanding of Mindful Awareness for Sleep (PUMAS) in people with Insomnia and Depression, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.