Postpartum Psychiatric DisordersMORPHENCT05840900
Mindfulness, Optimism, and Resilience for Perinatal Health and Empowerment Study
A study testing Digital Mindfulness Training in people with Postpartum Psychiatric Disorders, run by Nina Ayala at 2 sites in United States.
Trial summary
Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum Psychiatric Disorders
- What is being tested?
- Digital Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2024to 15 Oct 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide informed consent
- English speaking
- Nulliparous (no prior delivery at or greater than 20w0d gestation)
- Pregnant with singleton fetus
- <20w0d gestation
- Low dispositional optimism (score </= 14 on the Revised Life Orientation Test)
- Owns a smart phone
Who cannot join
- Plan to deliver at another institution
- Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga
- Pre-gestational hypertensive disorder
- Pre-gestational diabetes mellitus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Obstetrics and Gynecology Care Center
Providence, Rhode Island, 02905
Prenatal Diagnosis Center
Providence, Rhode Island, 02905
About this study
Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.
Read the detailed description
This randomized clinical trial of nulliparous women with low dispositional optimism in early pregnancy seeks to determine whether use of a pregnancy-oriented digital mindfulness application will be feasible and acceptable and show preliminary evidence of efficacy in improving dispositional optimism, reducing adverse perinatal outcomes and improving postpartum post-traumatic stress symptoms.
This pilot will include 100 women recruited from the obstetrical service at Women and Infants Hospital of Rhode Island. Women will be included if they are nulliparous, have a singleton pregnancy at <20 weeks gestational age, speak English and have low dispositional optimism (a score of ≤14 on the validated, Revised Life Orientation Test). Eligible participants will be randomized to either using the digital app Expectful or standard pregnancy care.
Women will be randomized with equal probability to the intervention group using block randomization stratified by race/ethnicity (Hispanic, non-Hispanic White/Other or non-Hispanic Black).
Women in the mindfulness training arm will complete 8 weeks of daily mindfulness training exercises using Expectful. Women in the standard care group will receive standard pregnancy and postpartum care. Pregnancy and labor management will be at the discretion of each participant's obstetric provider.
Participants in both groups will be asked to complete 4 questionnaires: one at enrollment, a post-intervention one at 8 weeks, at the time of delivery and at 6-8 weeks postpartum. Half of the participants in each arm (total n=50), will be asked to complete a qualitative, semi-structured interview on the role of optimism and other resilience factors in pregnancy.
- Conditions
- Postpartum Psychiatric Disorders
- Being tested
- Digital Mindfulness Training
- Keywords
- dispositional optimism, mindfulness, adverse perinatal outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Mindfulness TrainingBehavioural
Once daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful
| Study group | Role | What they receive |
|---|---|---|
| App-based mindfulness training | Experimental | App-based daily mindfulness training Standard prenatal and pregnancy care Receives: Behavioral: Digital Mindfulness Training |
| Usual Care | No intervention | Standard prenatal and pregnancy care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants completing the assigned mindfulness exercises
The intervention will be considered feasible if ≥75% participants complete >50% of the assigned daily mindfulness exercises over the 8-week intervention period
Measured: 8-week intervention period
Intervention acceptability
The intervention will be considered acceptable if ≥75% report "satisfied" or "very satisfied" on a post-intervention consumer satisfaction survey with a 5-point Likert scale from very unsatisfied to very satisfied.
Measured: After 8 week intervention period, approximately 16-28 weeks gestation.
Secondary outcomes (7)
Dispositional optimism
Change in dispositional optimism score (on validated Revised Life Orientation Test, scale range 0-24, higher scores indicate higher optimism) between enrollment and postpartum assessments
Measured: Study enrollment and 6-12 weeks postpartum
Cesarean delivery
Binary yes/no
Measured: Delivery
Hypertensive disorder of pregnancy
Binary yes/no; includes gestational hypertension, pre-eclampsia with or without severe features, HELLP syndrome or eclampsia
Measured: 6-12 weeks postpartum
Gestational diabetes mellitus
Binary yes/no
Measured: Delivery
Preterm birth
Binary yes/no; Delivery between 20w0d and 36w6d gestation
Measured: Delivery
Traumatic birth
Binary yes/no; Self-reported experience of birth as traumatic given concern for life or well-being of self or infant
Measured: Delivery
Postpartum post-traumatic stress symptoms
Continuous scale score using the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5, scale range 0-80, higher scores indicate worse post-traumatic stress symptoms)
Measured: 6-12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start20 Feb 2024
- Primary completion1 Aug 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum Psychiatric DisordersStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nina Ayala
- Sponsor type
- University, hospital or other
- Collaborators
- The Miriam Hospital
- Responsible party
- Sponsor-investigator, Nina Ayala, Women and Infants Hospital of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840900
- Sponsor's protocol ID
- 1983168
- Acronym
- MORPHE
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang E, Lewkowitz AK, Unger JA, Garfield CF, Miller ES. Smartphone Applications to Support Perinatal Mental Health. Obstet Gynecol. 2026 Feb 1;147(2):229-238. doi: 10.1097/AOG.0000000000006139. Epub 2025 Dec 18.
PubMed 41411652
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness, Optimism, and Resilience for Perinatal Health and Empowerment Study
- ClinicalTrials.gov ID
- NCT05840900
- Acronym / sponsor ID
- MORPHE / 1983168
- Conditions
- Postpartum Psychiatric Disorders
- Keywords
- dispositional optimism, mindfulness, adverse perinatal outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Nina AyalaUniversity, hospital or other
- Collaborators
- The Miriam Hospital
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 3 May 2023 (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.
Dispositional optimism (the general assumption that more good things than bad will occur across various life domains) has been tied to improved somatic and mental health outcomes. Dispositional optimism is malleable, although prior interventions have been time and resource intensive and thus are not well-tailored to the peripartum period. The purpose of this pilot study is to evaluate the feasibility and acceptability of a pregnancy-oriented mindfulness phone application (Expectful) versus standard care among first-time mothers with low dispositional optimism in early pregnancy. Other aims include evaluating the impact of Expectful use on dispositional optimism, adverse pregnancy outcomes (cesarean delivery, hypertensive disorders of pregnancy, and gestational diabetes) and postpartum post-traumatic stress symptoms.
Detailed description
This randomized clinical trial of nulliparous women with low dispositional optimism in early pregnancy seeks to determine whether use of a pregnancy-oriented digital mindfulness application will be feasible and acceptable and show preliminary evidence of efficacy in improving dispositional optimism, reducing adverse perinatal outcomes and improving postpartum post-traumatic stress symptoms.
This pilot will include 100 women recruited from the obstetrical service at Women and Infants Hospital of Rhode Island. Women will be included if they are nulliparous, have a singleton pregnancy at <20 weeks gestational age, speak English and have low dispositional optimism (a score of ≤14 on the validated, Revised Life Orientation Test). Eligible participants will be randomized to either using the digital app Expectful or standard pregnancy care.
Women will be randomized with equal probability to the intervention group using block randomization stratified by race/ethnicity (Hispanic, non-Hispanic White/Other or non-Hispanic Black).
Women in the mindfulness training arm will complete 8 weeks of daily mindfulness training exercises using Expectful. Women in the standard care group will receive standard pregnancy and postpartum care. Pregnancy and labor management will be at the discretion of each participant's obstetric provider.
Participants in both groups will be asked to complete 4 questionnaires: one at enrollment, a post-intervention one at 8 weeks, at the time of delivery and at 6-8 weeks postpartum. Half of the participants in each arm (total n=50), will be asked to complete a qualitative, semi-structured interview on the role of optimism and other resilience factors in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based mindfulness training | Experimental | Behavioral: Digital Mindfulness TrainingApp-based daily mindfulness training Standard prenatal and pregnancy care |
| Usual Care | No intervention | –Standard prenatal and pregnancy care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able to provide informed consent
- English speaking
- Nulliparous (no prior delivery at or greater than 20w0d gestation)
- Pregnant with singleton fetus
- <20w0d gestation
Key exclusion criteria (4 listed)
- Plan to deliver at another institution
- Ongoing (≥1/week) mind-body practice including mindfulness training, meditation or yoga
- Pre-gestational hypertensive disorder
- Pre-gestational diabetes mellitus
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 |
|---|---|---|
| Digital Mindfulness TrainingOnce daily, 5-10 minute mindfulness exercises for 8 week intervention period using the existing perinatal mindfulness application Expectful | Behavioural | App-based mindfulness training |
Primary outcome
Percentage of participants completing the assigned mindfulness exercises
Time frame: 8-week intervention period
The intervention will be considered feasible if ≥75% participants complete >50% of the assigned daily mindfulness exercises over the 8-week intervention period
Intervention acceptability
Time frame: After 8 week intervention period, approximately 16-28 weeks gestation.
The intervention will be considered acceptable if ≥75% report "satisfied" or "very satisfied" on a post-intervention consumer satisfaction survey with a 5-point Likert scale from very unsatisfied to very satisfied.
7 secondary outcomes
Dispositional optimism
Time frame: Study enrollment and 6-12 weeks postpartum
Cesarean delivery
Time frame: Delivery
Hypertensive disorder of pregnancy
Time frame: 6-12 weeks postpartum
Gestational diabetes mellitus
Time frame: Delivery
Preterm birth
Time frame: Delivery
Traumatic birth
Time frame: Delivery
Postpartum post-traumatic stress symptoms
Time frame: 6-12 weeks 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 30 Oct 2026.
- Derived from this study: PubMed 41411652Chang E, Lewkowitz AK, Unger JA, Garfield CF, Miller ES. Smartphone Applications to Support Perinatal Mental Health. Obstet Gynecol. 2026 Feb 1;147(2):229-238. doi: 10.1097/AOG.0000000000006139. Epub 2025 Dec 18.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Mindfulness Training in people with Postpartum Psychiatric Disorders, run by Nina Ayala at 2 sites 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 4 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 30 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 2 sites 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?
Percentage of participants completing the assigned mindfulness exercises (time frame: 8-week intervention period). 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?
On the ClinicalTrials.gov record for NCT05840900, which also lists 1 linked publication.
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 30 Oct 2026.