InsomniaNCT04443959
Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
A study testing PUMAS in people with Insomnia, run by Henry Ford Health System at 1 site in United States.
Trial summary
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during 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?
- PUMAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 22 Nov 2022
- 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 18-30 weeks.
- (2) Insomnia Severity Index score of 11 or higher
- (3) age between 18 and 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in online treatment and online study outcome assessments
Who cannot join
- (1) High risk pregnancy as reported by the patient, which includes but is not limited to pre-eclampsia, gestational diabetes, maternal age > 40, ectopic pregnancy, fetal problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and placental abruption.
- (2) bipolar disorder or seizure disorders [contraindicated for insomnia therapy] as reported by the patient
- (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible to participate as multiple pregnancy can increase risk of complications and often leads to preterm or early-term birth
- (4) any conditions or difficulties that would prevent the patient from completing online treatment and/or online surveys, including but not limited to language difficulties, literacy issues, visual or auditory impairment, and cognitive deficits
- (5) active suicidal intent
Trial locations and contacts
1 site in 1 country.
About this study
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can safely improve sleep and mood during pregnancy. Yet, no published studies to date have combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep and mood at the same time in pregnant and postpartum women. This study is the first to combine behavioral sleep strategies with mindfulness-meditation to improve sleep and psychological wellbeing of expecting and new moms.
The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well as reduce stress in pregnant women.
Read the detailed description
The purpose of this open-label trial is to determine the efficacy of and patient engagement in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The investigators' long-term goal is to improve sleep and mood of expecting and new mothers. 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 women and new moms may be greatly improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that online cognitive-behavioral therapy for insomnia (CBTI) greatly improved sleep during pregnancy, and offered some protection against sleep problems after childbirth. Women in this trial were highly satisfied with CBTI and especially its remote delivery. However, the investigators identified important shortcomings of online CBTI in this population. Namely, patients provided feedback that reducing cognitive arousal (ie ruminative or worrisome thinking) was an important therapeutic target, that more mindfulness-based approaches and strategies would improve treatment, and that greater emphasis on maternal and infant sleep would also enhance the treatment experience. Thus, the investigators will conduct an open label trial to collect pilot data on the efficacy of a telemedicine mindfulness-based intervention for prenatal insomnia that has been tailored for pregnant women. Specifically, the investigators will conduct this open-label trial of 50 pregnant women to preliminary test the efficacy, patient adherence, patient engagement, and patient satisfaction with this telemedicine program.
This open-label trial will enroll 50 pregnant women (gestational age 18-30 weeks at study entry) who will receive 6 sessions of 'Perinatal Understanding of Mindful Awareness for Sleep' (PUMAS) via telemedicine video with a therapist. Patients will complete this treatment during pregnancy. This program was based on Dr. Jason Ong's Mindfulness-Based Therapy for Insomnia, which combined CBTI and mindfulness meditation, and it has been tailored for perinatal women. The investigators will assess study outcomes before treatment and after treatment. Study outcomes will include insomnia symptoms, depressive symptoms, and cognitive arousal. The investigators will also assess patient engagement (number of completed sessions, homework adherence) and collect patient feedback (e.g., treatment satisfaction).
- Conditions
- Insomnia
- Being tested
- PUMAS
- Keywords
- Mindfulness, Cognitive arousal, insomnia, pregnant, perinatal
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUMASBehavioural
Treatment consists of 6 weekly telemedicine sessions during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| PUMAS Treatment | Experimental | Prenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women. Receives: Behavioral: PUMAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of PUMAS 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: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
Secondary outcomes (2)
Effectiveness of PUMAS for changes in depressive symptoms
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: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
Effectiveness of PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor
The Presleep Arousal Scale - Cognitive Factor is a commonly used self-report measure of insomnia symptoms 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: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2020
- Study start15 Aug 2022
- Primary completion22 Nov 2022
- Study completion22 Nov 2022
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT04443959
- Sponsor's protocol ID
- PPD2
- Status last verified
- Dec 2022
- First submitted
- 19 Jun 2020
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Espie CA, Seymour GM, Hirata M, Walch O, Pitts DS, Roth T, Drake CL. Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program. Sleep Adv. 2023 Aug 5;4(1):zpad031. doi: 10.1093/sleepadvances/zpad031. eCollection 2023.
PubMed 37645455Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Fresco DM, Walch O, Seymour GM, Fellman-Couture C, Bayoneto AD, Roth T, Drake CL. Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy. Sleep Med. 2023 Aug;108:79-89. doi: 10.1016/j.sleep.2023.05.026. Epub 2023 Jun 10.
PubMed 37343335
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine Mindfulness-based Therapy for Perinatal Insomnia: An Open-label Trial.
- ClinicalTrials.gov ID
- NCT04443959
- Acronym / sponsor ID
- PPD2
- Conditions
- Insomnia
- Keywords
- Mindfulness, Cognitive arousal, insomnia, pregnant, perinatal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 22 Nov 2022 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 23 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.
Over half of pregnant and postpartum women experience clinical insomnia. However, treatment options are very limited for pregnant women and moms of newborns. Sleep aids are not considered safe during pregnancy and may increase risks about safety for mom and baby during postpartum. Recent clinical trials show that behavioral and mindfulness-based treatments can safely improve sleep and mood during pregnancy. Yet, no published studies to date have combined behavioral sleep treatment with mindfulness-based stress reduction to improve sleep and mood at the same time in pregnant and postpartum women. This study is the first to combine behavioral sleep strategies with mindfulness-meditation to improve sleep and psychological wellbeing of expecting and new moms.
The purpose of this research study is to examine the effectiveness of a mindfulness-based intervention for prenatal insomnia via telemedicine format to improve sleep and mood as well as reduce stress in pregnant women.
Detailed description
The purpose of this open-label trial is to determine the efficacy of and patient engagement in mindfulness-based intervention for prenatal insomnia delivered via telemedicine. The investigators' long-term goal is to improve sleep and mood of expecting and new mothers. 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 women and new moms may be greatly improved. In a prior clinical trial, Dr. Kalmbach (PI) showed that online cognitive-behavioral therapy for insomnia (CBTI) greatly improved sleep during pregnancy, and offered some protection against sleep problems after childbirth. Women in this trial were highly satisfied with CBTI and especially its remote delivery. However, the investigators identified important shortcomings of online CBTI in this population. Namely, patients provided feedback that reducing cognitive arousal (ie ruminative or worrisome thinking) was an important therapeutic target, that more mindfulness-based approaches and strategies would improve treatment, and that greater emphasis on maternal and infant sleep would also enhance the treatment experience. Thus, the investigators will conduct an open label trial to collect pilot data on the efficacy of a telemedicine mindfulness-based intervention for prenatal insomnia that has been tailored for pregnant women. Specifically, the investigators will conduct this open-label trial of 50 pregnant women to preliminary test the efficacy, patient adherence, patient engagement, and patient satisfaction with this telemedicine program.
This open-label trial will enroll 50 pregnant women (gestational age 18-30 weeks at study entry) who will receive 6 sessions of 'Perinatal Understanding of Mindful Awareness for Sleep' (PUMAS) via telemedicine video with a therapist. Patients will complete this treatment during pregnancy. This program was based on Dr. Jason Ong's Mindfulness-Based Therapy for Insomnia, which combined CBTI and mindfulness meditation, and it has been tailored for perinatal women. The investigators will assess study outcomes before treatment and after treatment. Study outcomes will include insomnia symptoms, depressive symptoms, and cognitive arousal. The investigators will also assess patient engagement (number of completed sessions, homework adherence) and collect patient feedback (e.g., treatment satisfaction).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PUMAS Treatment | Experimental | Behavioral: PUMASPrenatal insomnia program that places behavioral sleep strategies within a mindfulness-based intervention framework that is geared toward pregnant women. |
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 18-30 weeks.
- (2) Insomnia Severity Index score of 11 or higher
- (3) age between 18 and 40 years
- (4) reliable and adequately fast internet connection at home, which is required to engage in online treatment and online study outcome assessments
Key exclusion criteria (5 listed)
- (1) High risk pregnancy as reported by the patient, which includes but is not limited to pre-eclampsia, gestational diabetes, maternal age > 40, ectopic pregnancy, fetal problems (e.g., heart problems), hyperemesis gravidarum, placenta previa, and placental abruption.
- (2) bipolar disorder or seizure disorders [contraindicated for insomnia therapy] as reported by the patient
- (3) women with multiple pregnancy (e.g., twins, triplets, etc.) will not be eligible to participate as multiple pregnancy can increase risk of complications and often leads to preterm or early-term birth
- (4) any conditions or difficulties that would prevent the patient from completing online treatment and/or online surveys, including but not limited to language difficulties, literacy issues, visual or auditory impairment, and cognitive deficits
- (5) active suicidal intent
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 |
|---|---|---|
| PUMASTreatment consists of 6 weekly telemedicine sessions during pregnancy. | Behavioural | PUMAS Treatment |
Primary outcome
Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI)
Time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
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 PUMAS for changes in depressive symptoms
Time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
Effectiveness of PUMAS for changes in of cognitive arousal- Presleep Arousal Scale- Cognitive Factor
Time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).
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 14 Dec 2022.
- Derived from this study: PubMed 37645455Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Espie CA, Seymour GM, Hirata M, Walch O, Pitts DS, Roth T, Drake CL. Reducing cognitive arousal and sleep effort alleviates insomnia and depression in pregnant women with DSM-5 insomnia disorder treated with a mindfulness sleep program. Sleep Adv. 2023 Aug 5;4(1):zpad031. doi: 10.1093/sleepadvances/zpad031. eCollection 2023.
- Derived from this study: PubMed 37343335Kalmbach DA, Cheng P, Reffi AN, Ong JC, Swanson LM, Fresco DM, Walch O, Seymour GM, Fellman-Couture C, Bayoneto AD, Roth T, Drake CL. Perinatal Understanding of Mindful Awareness for Sleep (PUMAS): A single-arm proof-of-concept clinical trial of a mindfulness-based intervention for DSM-5 insomnia disorder during pregnancy. Sleep Med. 2023 Aug;108:79-89. doi: 10.1016/j.sleep.2023.05.026. Epub 2023 Jun 10.
- 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 PUMAS 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 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 14 Dec 2022. 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?
Effectiveness of PUMAS for changes in insomnia symptoms - Insomnia Severity Index (ISI) (time frame: Pretreatment, then posttreatment (after completing prenatal treatment or 10 weeks after starting prenatal treatment).). 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 NCT04443959, 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 14 Dec 2022.