InsomniaINSPIRENCT04445805
Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
A study testing Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal-enhanced Behavioral Therapy for Insomnia in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBTI) and Perinatal-enhanced Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 31 Dec 2023
- 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
- (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
- (2) Insomnia Severity Index score > 10
- (3) age 18 - 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
Who cannot join
- High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age>40)
- Bipolar disorder (contraindicated for CBTI)
- Seizures (contraindicated for CBTI)
- Active suicidal intent
- Shift work
- Patients who cannot reasonably engage in study activities including treatment or completing online surveys will be excluded regardless of reason. This may include inability to comprehend the English language, inability to hear therapist over video sessions, inability to understand and meaningfully answer study outcomes measures, or other barriers to participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The INSPIRE Trial: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.
Read the detailed description
The purpose of this randomized controlled trial is to determine the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control. The long-term goal is to maximize the effectiveness of insomnia treatment for perinatal women by adapting safe and efficacious treatments to meet the evolving needs of women through pregnancy and postpartum. Over half of pregnant women develop insomnia, which is associated with high rates of depression during pregnancy and postpartum. By successfully treating insomnia during pregnancy and improving cognitive-emotion regulation, mental health of pregnant and postpartum women may be substantially improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved sleep during pregnancy, and offered some protection against sleep problems after childbirth. Women in this prior trial were highly satisfied with CBTI and the ability to participate in treatment remotely. However, the investigators identified important shortcomings of CBTI in this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in insomnia patients, which has immense potential to enhance sleep and mental health outcomes in perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal intervention control.
The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will address changes in sleep symptoms and challenges that emerge after childbirth. The investigators will collect outcome data on insomnia symptoms and related health outcomes (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first postpartum year. The investigators will determine the efficacy of the investigator's CBTI and MBTI protocols for perinatal insomnia relative to minimal intervention control. The investigators will then compare the effects of CBTI and MBTI on short- and long-term outcomes.
- Conditions
- Insomnia
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBTI), Perinatal-enhanced Behavioral Therapy for Insomnia, Attention Control
- Keywords
- Insomnia, Telemedecine, pregnancy, perinatal, Cognitive Arousal, depression
- 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
Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.
Perinatal-enhanced Behavioral Therapy for InsomniaBehavioural
Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.
Attention ControlBehavioural
Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.
| Study group | Role | What they receive |
|---|---|---|
| CBTI Treatment Group | Active comparator | Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI) |
| Perinatal-enhanced behavioral therapy for insomnia | Experimental | Telemedicine Mindfulness Based Therapy for Insomnia (MBTI) Receives: Behavioral: Perinatal-enhanced Behavioral Therapy for Insomnia |
| Attention Control Treatment Group | Placebo comparator | Minimal intervention control Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores < 8 after treatment indicate remission.
Measured: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Secondary outcomes (2)
Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
The Edinburgh Postnatal Depression (EPDS) is the most widely used depression measure in both pregnant and postnatal women. It is validated for use in community samples and clinical trials. The EPDS scores range from 0-30, with a higher score indicating a greater severity of depression.
Measured: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
The Presleep Arousal Scale- Cognitive Factor is a commonly used self-report measure of nocturnal cognitive arousal that has been validated for use in community samples and clinical trials. The scores range from 8-40, with a higher score indicating a greater severity of nocturnal cognitive arousal.
Measured: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start15 Mar 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 64 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
- Investigators
- David Kalmbach, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445805
- Sponsor's protocol ID
- INSPIRE
- Acronym
- INSPIRE
- Status last verified
- Jan 2024
- First submitted
- 19 Jun 2020
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kalmbach DA, Reffi AN, Cheng P, Kaliush PR, Jennings MB, Afaneh HA, Yu A, Jaziri M, Drake CL. Treating insomnia during pregnancy improves bedtime procrastination, rumination, anxiety, and positive affect: a randomized controlled trial of cognitive-behavioral and mindfulness-based therapies for prenatal insomnia. Sleep Adv. 2026 Apr 30;7(2):zpag050. doi: 10.1093/sleepadvances/zpag050. eCollection 2026.
PubMed 42317199Kalmbach DA, Ong JC, Cheng P, Reffi AN, Swanson LM, Hirata M, Seymour GM, Castelan-Cuamatzi AS, Jennings MB, Pitts DS, Roth A, Roth T, Drake CL. A randomized controlled trial of telemedicine CBTI and PUMAS for prenatal insomnia: Reducing nocturnal cognitive arousal is a treatment mechanism for alleviating insomnia and depression during pregnancy. Sleep Med. 2025 Sep;133:106570. doi: 10.1016/j.sleep.2025.106570. Epub 2025 May 12.
PubMed 40413907
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INSPIRE Trial: Improving Negative Stressful Perseverations in Insomnia to Revitalize Expectant Moms
- ClinicalTrials.gov ID
- NCT04445805
- Acronym / sponsor ID
- INSPIRE / INSPIRE
- Conditions
- Insomnia
- Keywords
- Insomnia, Telemedecine, pregnancy, perinatal, Cognitive Arousal, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Jun 2020 (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.
The purpose of this research is to evaluate telemedicine treatments for sleep in pregnant women. As pregnant women are vulnerable to sleep problems, the investigators aim to explore whether these types of treatment will improve sleep and mood-related health risks in pregnancy and postpartum. The investigators will test the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control.
Detailed description
The purpose of this randomized controlled trial is to determine the efficacy of cognitive behavioral therapy for insomnia (CBTI) and mindfulness-based therapy for insomnia (MBTI) for perinatal insomnia relative to sleep education and hygiene, which is a minimal intervention control. The long-term goal is to maximize the effectiveness of insomnia treatment for perinatal women by adapting safe and efficacious treatments to meet the evolving needs of women through pregnancy and postpartum. Over half of pregnant women develop insomnia, which is associated with high rates of depression during pregnancy and postpartum. By successfully treating insomnia during pregnancy and improving cognitive-emotion regulation, mental health of pregnant and postpartum women may be substantially improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that digital CBTI (i.e., fully automated online program) improved sleep during pregnancy, and offered some protection against sleep problems after childbirth. Women in this prior trial were highly satisfied with CBTI and the ability to participate in treatment remotely. However, the investigators identified important shortcomings of CBTI in this population. Namely, standard CBTI was ineffective at reducing cognitive arousal and depression. Preliminary data suggest that MBTI may effectively reduce cognitive arousal in insomnia patients, which has immense potential to enhance sleep and mental health outcomes in perinatal insomnia. Thus, the investigators will conduct a randomized controlled trial to determine the efficacy of MBTI and CBTI for perinatal insomnia relative to a minimal intervention control.
The current study is a 3-arm RCT comparing CBTI and MBTI to sleep education and hygiene minimal intervention control for the treatment of perinatal insomnia. 120 women with insomnia symptoms will be treated beginning in pregnancy and into early postpartum. CBTI and MBTI will address changes in sleep symptoms and challenges that emerge after childbirth. The investigators will collect outcome data on insomnia symptoms and related health outcomes (e.g., cognitive arousal, depression) after prenatal treatment and monthly across the first postpartum year. The investigators will determine the efficacy of the investigator's CBTI and MBTI protocols for perinatal insomnia relative to minimal intervention control. The investigators will then compare the effects of CBTI and MBTI on short- and long-term outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBTI Treatment Group | Active comparator | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBTI)Telemedicine Cognitive Behavioral Therapy for Insomnia (CBTI) |
| Perinatal-enhanced behavioral therapy for insomnia | Experimental | Behavioral: Perinatal-enhanced Behavioral Therapy for InsomniaTelemedicine Mindfulness Based Therapy for Insomnia (MBTI) |
| Attention Control Treatment Group | Placebo comparator | Behavioral: Attention ControlMinimal intervention control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- (1) Gestational age at time of study enrollment must be less than or equal to 28 weeks
- (2) Insomnia Severity Index score > 10
- (3) age 18 - 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in telemedicine treatment (online video) and online study outcome assessments.
Key exclusion criteria (6 listed)
- High risk pregnancy (e.g., pre-eclampsia, multiple pregnancy, age>40)
- Bipolar disorder (contraindicated for CBTI)
- Seizures (contraindicated for CBTI)
- Active suicidal intent
- Shift work
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)Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine. | Behavioural | CBTI Treatment Group |
| Perinatal-enhanced Behavioral Therapy for InsomniaConsists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine. | Behavioural | Perinatal-enhanced behavioral therapy for insomnia |
| Attention ControlWill include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries. | Behavioural | Attention Control Treatment Group |
Primary outcome
Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI)
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
The Insomnia Severity Index (ISI) is a commonly used self-report measure of insomnia symptoms that has been validated for use in community samples and clinical trials. The ISI scores range from 0-28, with a higher score indicating a greater severity of insomnia. ISI scores < 8 after treatment indicate remission.
2 secondary outcomes
Effectiveness of mindfulness based therapy for insomnia for changes in depression symptoms- Edinburgh Postnatal Depression Scale (EPDS)
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
Effectiveness of mindfulness based therapy for insomnia for changes in cognitive arousal - Presleep Arousal Scale-Cognitive Factor
Time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year
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 19 Jan 2024.
- Derived from this study: PubMed 42317199Kalmbach DA, Reffi AN, Cheng P, Kaliush PR, Jennings MB, Afaneh HA, Yu A, Jaziri M, Drake CL. Treating insomnia during pregnancy improves bedtime procrastination, rumination, anxiety, and positive affect: a randomized controlled trial of cognitive-behavioral and mindfulness-based therapies for prenatal insomnia. Sleep Adv. 2026 Apr 30;7(2):zpag050. doi: 10.1093/sleepadvances/zpag050. eCollection 2026.
- Derived from this study: PubMed 40413907Kalmbach DA, Ong JC, Cheng P, Reffi AN, Swanson LM, Hirata M, Seymour GM, Castelan-Cuamatzi AS, Jennings MB, Pitts DS, Roth A, Roth T, Drake CL. A randomized controlled trial of telemedicine CBTI and PUMAS for prenatal insomnia: Reducing nocturnal cognitive arousal is a treatment mechanism for alleviating insomnia and depression during pregnancy. Sleep Med. 2025 Sep;133:106570. doi: 10.1016/j.sleep.2025.106570. Epub 2025 May 12.
- Individual participant dataSharing planned: Undecided
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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.
David Kalmbach, PhD principal investigator
Henry Ford Health System
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-enhanced Behavioral Therapy for Insomnia in people with Insomnia, 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 4 inclusion and 6 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 19 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Effectiveness of mindfulness based therapy for insomnia for changes in insomnia symptoms - Insomnia Severity Index (ISI) (time frame: Will be assessed pretreatment, immediately posttreatment, and monthly across the 1st postnatal year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445805, which also lists 2 linked publications.
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 19 Jan 2024.