Substance Use DisorderNCT07211867
A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
A study testing Enhearten with EMI in people with Substance Use Disorder, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Digital interventions have the potential to support healthier behaviors among pregnant and postpartum women (PPW) with substance use disorders (SUDs) and may also provide a promising method for reducing their self-stigma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- Enhearten with EMI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Pregnant women and new mothers (up to 12 months postpartum)
- Adult (≥18 years of age)
- Fluent in English
- Currently owns or has ready (daily) access to a smartphone or tablet to use Enhearten.
- Self-reports a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician OR a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician, is identified in chart review as documented by a healthcare provider
Who cannot join
- Significant cognitive impairment that interferes with their ability to consent and complete study tasks as self-reported or documented in medical charts by a healthcare provider
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Alex T Ramsey, Ph.D., 314-362-5370, aramsey@wustl.edu
Alex T Ramsey, Ph.D.
About this study
Digital interventions have the potential to support healthier behaviors among pregnant and postpartum women (PPW) with substance use disorders (SUDs) and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention designed to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. The investigators will conduct an individual-level multicenter randomized controlled trial to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities among PPW with SUD via just-in-time interventions.
Read the detailed description
Pregnant and postpartum women (PPW) with substance use disorders (SUDs) face high levels of self-stigma, the internalization of negative feelings about oneself because of drug misuse. Self-stigma is highly correlated with numerous detrimental consequences including recovery outcomes and reduced engagement with SUD treatment. Furthermore, self-stigma prevents treatment initiation and engagement among PPW with SUDs, leading to additional adverse health outcomes for both mother and baby. Digital interventions have the potential to support healthier behaviors among PPW with SUDs and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention that has been enhanced to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. In this study, the investigators will test this augmented version of Enhearten with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities via just-in-time interventions. Specifically, the investigators will conduct an individual-level multi-center randomized control trial (RCT) to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes. Participants will be randomized to one of two groups: Enhearten with EMI or a waitlist control group (i.e., participants will have access to the intervention following the RCT). Recruitment will occur through treatment facilities and recovery homes throughout the United States, referrals from stakeholders including clinicians and peer support specialists, and approved research recruitment registries. This study will determine the efficacy and utility of Enhearten among PPW with SUDs, addressing a promising solution to supplement traditional in-person care, reduce self-stigma, and support continued motivation and adherence to treatment plans along the recovery journey.
- Conditions
- Substance Use Disorder
- Being tested
- Enhearten with EMI, Waitlist Control Group
- Keywords
- pregnant and postpartum women, self-stigma, digital interventions, substance use disorder
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhearten with EMIBehavioural
Enhearten is a digital intervention that is designed to foster adherence to medications for addiction treatment (MAT) and treatment retention while considering the unique needs of pregnant and postpartum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users
Waitlist Control GroupBehavioural
Participants will receive access to Enhearten with EMI following the trial.
| Study group | Role | What they receive |
|---|---|---|
| Enhearten with EMI | Experimental | Enhearten is a digital intervention that is designed to foster adherence to medications for addiction treatment (MAT) and treatment retention while considering the unique needs of pregnant and post-partum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users. Receives: Behavioral: Enhearten with EMI |
| Waitlist Control Group | Active comparator | Participants in this arm will have access to the intervention following the trial. Receives: Behavioral: Waitlist Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-stigma about substance use
Participants in each group will be assessed on levels of perceived self-stigma using the Brief Substance Use Stigma Scale ). The Brief Substance Use Stigma Scale uses a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.
Measured: Baseline through 6-months post-intervention
Internalized stigma about substance use
Participants in each group will be assessed on levels of perceived self-stigma using the Internalized Stigma of Substance Abuse Scale (ISSA). The Internalized Stigma of Substance Abuse Scale (ISSA) uses a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.
Measured: Baseline through 6-months post-intervention
Secondary outcomes (10)
Use of Medications for Addiction Treatment (MAT)
Participants in each group will be assessed on self-reported use of medications for opioid use disorder or other medications for addiction treatment in the past 30 days.
Measured: Baseline through 6-months post-intervention
Substance use
Participants in each group will be assessed on self-reported use of substances for nonmedical purposes (i.e. opioids, methamphetamine, cocaine, MDMAs, etc) in the past 30 days. Substance use and related symptoms will be assessed using modified items from the National Survey on Drug Use and Health (NSDUH).
Measured: Baseline through 6 months post-intervention
Substance use cravings
Participants in each group will be assessed on self-reported cravings to use substances for nonmedical purposes (i.e. opioids, methamphetamine, cocaine, MDMAs, etc). Substance use cravings will be assessed using modified items from the Penn Alcohol Craving Scale (PACS). The scale uses a 0-6 Likert scale for each of its five items, with a total possible score ranging from 0 to 30, where higher total scores reflect more intense or frequent cravings.
Measured: Baseline through 6 months post-intervention
Attitudes towards using medication for addiction treatment during pregnancy/postpartum
Participants in each group will be assessed on an attitudes measure towards use of medications for addiction treatment during the pregnancy/postpartum period, stemming from the Theory of Planned Behavior. This measure uses a 6-point Likert scale ranging from "strongly disagree" to "strongly agree".
Measured: Baseline through 6 months post-intervention
Subjective norms towards using medication for addiction treatment
Participants in each group will be assessed on a subjective norms measure towards use of medications for addiction treatment, stemming from the Theory of Planned Behavior.
Measured: Baseline through 6 months post-intervention
Self-efficacy towards using medication for addiction treatment
Participants in each group will be assessed on a self-efficacy measure towards use of medications for addiction treatment, stemming from the Theory of Planned Behavior.
Measured: Baseline through 6 months post-intervention
Mental health symptoms
Participants in each group will be assessed on symptoms of mental health from the Medical Outcomes Survey, including symptoms related to depression, anxiety, and distress.
Measured: Baseline through 6 months post-intervention
Infant feeding intentions
Participants in each group who are pregnant will be assessed on intent to breastfeed using The Infant Feeding Intentions (IFI) scale. This measure uses a 5-point Likert-type scale ranging from "very much agree" to "very much disagree".
Measured: Baseline through 6 months post-intervention
Usability and usefulness of intervention
Participants in the intervention group will be assessed on usability and usefulness of the Enhearten app using a modified version of the Technology Acceptance Model (TAM). The TAM uses a 7-point Likert scale ranging from "totally disagree" to "totally agree" with higher scores indicating higher levels of usability and usefulness.
Measured: 1-month post-intervention to 6-months post-intervention
Acceptability of intervention
Participants in the intervention group will be assessed on acceptability of the Enhearten app using a modified version of the Acceptability of Intervention Measure (AIM) questionnaire. The modified version of the AIM uses a 7-point Likert scale, ranging from "totally disagree" to "totally agree". Mean scores will be created with higher scores indicating higher levels of acceptability.
Measured: 1-month post-intervention to 6-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start24 Nov 2025
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Alex T Ramsey, Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211867
- Sponsor's protocol ID
- 202302102
- Other IDs
- R44DA055161
- Status last verified
- Nov 2026
- First submitted
- 26 Sep 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The university will share de-identified data from the RCT. Descriptions of study datasets, final codebook and data dictionary, and programming code for data management and analysis will also be made available. Data and documentation will be housed at Washington University but will be made freely available to other investigators who wish to conduct data audits or perform secondary data analyses.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Intervention to Decrease Self-Stigma Among Pregnant and Postpartum Women With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT07211867
- Acronym / sponsor ID
- 202302102
- Conditions
- Substance Use Disorder
- Keywords
- pregnant and postpartum women, self-stigma, digital interventions, substance use disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Oct 2025 (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.
Digital interventions have the potential to support healthier behaviors among pregnant and postpartum women (PPW) with substance use disorders (SUDs) and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention designed to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. The investigators will conduct an individual-level multicenter randomized controlled trial to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities among PPW with SUD via just-in-time interventions.
Detailed description
Pregnant and postpartum women (PPW) with substance use disorders (SUDs) face high levels of self-stigma, the internalization of negative feelings about oneself because of drug misuse. Self-stigma is highly correlated with numerous detrimental consequences including recovery outcomes and reduced engagement with SUD treatment. Furthermore, self-stigma prevents treatment initiation and engagement among PPW with SUDs, leading to additional adverse health outcomes for both mother and baby. Digital interventions have the potential to support healthier behaviors among PPW with SUDs and may also provide a promising method for reducing their self-stigma. Enhearten is a digital intervention that has been enhanced to foster adherence to medications for addiction treatment (MAT) while considering the unique needs of PPW, but its effects on self-stigma, treatment retention, and SUD outcomes have not been rigorously tested. In this study, the investigators will test this augmented version of Enhearten with a stigma-focused ecological momentary intervention (EMI) designed to: 1) screen for feelings of stigma and 2) counteract these vulnerabilities via just-in-time interventions. Specifically, the investigators will conduct an individual-level multi-center randomized control trial (RCT) to test the feasibility, acceptability, and efficacy of Enhearten on reducing self-stigma and on improving SUD treatment and recovery outcomes. Participants will be randomized to one of two groups: Enhearten with EMI or a waitlist control group (i.e., participants will have access to the intervention following the RCT). Recruitment will occur through treatment facilities and recovery homes throughout the United States, referrals from stakeholders including clinicians and peer support specialists, and approved research recruitment registries. This study will determine the efficacy and utility of Enhearten among PPW with SUDs, addressing a promising solution to supplement traditional in-person care, reduce self-stigma, and support continued motivation and adherence to treatment plans along the recovery journey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhearten with EMI | Experimental | Behavioral: Enhearten with EMIEnhearten is a digital intervention that is designed to foster adherence to medications for addiction treatment (MAT) and treatment retention while considering the unique needs of pregnant and post-partum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users. |
| Waitlist Control Group | Active comparator | Behavioral: Waitlist Control GroupParticipants in this arm will have access to the intervention following the trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women and new mothers (up to 12 months postpartum)
- Adult (≥18 years of age)
- Fluent in English
- Currently owns or has ready (daily) access to a smartphone or tablet to use Enhearten.
- Self-reports a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician OR a history of substance use, excluding alcohol use, nicotine/tobacco use, and drugs taken as prescribed by a physician, is identified in chart review as documented by a healthcare provider
Key exclusion criteria (1 listed)
- Significant cognitive impairment that interferes with their ability to consent and complete study tasks as self-reported or documented in medical charts by a healthcare provider
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 |
|---|---|---|
| Enhearten with EMIEnhearten is a digital intervention that is designed to foster adherence to medications for addiction treatment (MAT) and treatment retention while considering the unique needs of pregnant and postpartum women, and recently it has been adapted to include features designed to decrease self-stigma among app-users | Behavioural | Enhearten with EMI |
| Waitlist Control GroupParticipants will receive access to Enhearten with EMI following the trial. | Behavioural | Waitlist Control Group |
Primary outcome
Self-stigma about substance use
Time frame: Baseline through 6-months post-intervention
Participants in each group will be assessed on levels of perceived self-stigma using the Brief Substance Use Stigma Scale ). The Brief Substance Use Stigma Scale uses a 5-point Likert scale, ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.
Internalized stigma about substance use
Time frame: Baseline through 6-months post-intervention
Participants in each group will be assessed on levels of perceived self-stigma using the Internalized Stigma of Substance Abuse Scale (ISSA). The Internalized Stigma of Substance Abuse Scale (ISSA) uses a 4-point Likert scale ranging from "strongly disagree" to "strongly agree". Mean scores will be created with higher scores indicating higher levels of stigma.
10 secondary outcomes
Use of Medications for Addiction Treatment (MAT)
Time frame: Baseline through 6-months post-intervention
Substance use
Time frame: Baseline through 6 months post-intervention
Substance use cravings
Time frame: Baseline through 6 months post-intervention
Attitudes towards using medication for addiction treatment during pregnancy/postpartum
Time frame: Baseline through 6 months post-intervention
Subjective norms towards using medication for addiction treatment
Time frame: Baseline through 6 months post-intervention
Self-efficacy towards using medication for addiction treatment
Time frame: Baseline through 6 months post-intervention
Mental health symptoms
Time frame: Baseline through 6 months post-intervention
Infant feeding intentions
Time frame: Baseline through 6 months post-intervention
Usability and usefulness of intervention
Time frame: 1-month post-intervention to 6-months post-intervention
Acceptability of intervention
Time frame: 1-month post-intervention to 6-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. The university will share de-identified data from the RCT. Descriptions of study datasets, final codebook and data dictionary, and programming code for data management and analysis will also be made available. Data and documentation will be housed at Washington University but will be made freely available to other investigators who wish to conduct data audits or perform secondary data analyses.
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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.
Alex T Ramsey, Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhearten with EMI in people with Substance Use Disorder, run by Washington University School of Medicine 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alex T Ramsey, Ph.D. (314-362-5370, aramsey@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-stigma about substance use (time frame: Baseline through 6-months post-intervention). 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 4 Nov 2026.