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NCT Number: NCT07485036

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

This study aims to learn about depression and alcohol use in postpartum mothers and whether an intervention based on contingency management and problem-solving therapy (CM-PST) can help reduce these symptoms. The main questions it seeks to answer are:

1. How do new mothers fare with depressive symptoms and alcohol use in the first 12 months after giving birth? 2. Will a CM-PST intervention reduce depressive symptoms and alcohol use frequency among new mothers? 3. Is a CM-PST intervention practical for new mothers?

The researchers will recruit approximately 30 new mothers and randomly select half to attend a 6-week CM-PST intervention. They will compare those who received the intervention versus those who did not to see if there are any differences in their depressive symptoms and alcohol usage.

Participants will:

* Complete 4 remote intervention sessions over 6 weeks * Conduct at-home urine drug tests 2x per week during the 6-week intervention * Answer online surveys about their mental health and alcohol use

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Key information

Conditions

Postpartum Depression (PPD) Alcohol Drinking Alcohol Use Behavior Contingency Management Depression, Postpartum Depressive Disorder Drinking Behavior Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Problem Solving Therapy Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Hospital and Health Sciences System, University of Illinois College of Medicine

Chicago, Illinois, 60612, United States

Location contact

Hagar Hallihan, PhD

PRINCIPAL_INVESTIGATOR

Hagar Hallihan, PhD, RN

CONTACT

[email protected]

312-413-5361

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Biologically female
  • Age ≥18 years
  • Within 12 months postpartum
  • Able to provide informed consent

Exclusion criteria

  • Serious medical or psychiatric conditions requiring hospitalization
  • Lifetime DSM-5 diagnosis of schizophrenia, bipolar disorder, or any psychiatric disorder
  • Current use of psychoactive drugs, medication to treat problematic alcohol use, or depression
  • Participation in past 6 months in problematic alcohol use or substance use treatment
  • Unable to provide consent

Treatment and study plan

Contingency Management & Problem Solving Therapy

Behavioral

A 6-week online CM-PST course delivered through video conferencing calls consisting of 4 educational sessions, combined with 2x weekly at-home drug testing to monitor the reduction in alcohol use and reduced depression symptoms.

Usual Care

Other

Participants randomized to the usual care condition will continue to receive standard postpartum care from their obstetrician-gynecologist, consistent with routine clinical practice. No additional psychological intervention will be provided as part of the study.

Primary outcomes

  1. Change in postpartum depression symptoms

    Time frame: Screening, Baseline, 3 months

    Participants will take the Edinburgh Postnatal Depression Scale (EPDS) at screening, baseline and at 3 months to assess changes in mental health and depressive symptoms. This is reported on a scale of 0-30; a higher score indicates a higher likelihood of postpartum depression.

  2. Alcohol use test results

    Time frame: Baseline, Weekly, 3 months

    Participants' alcohol use will be monitored and assessed with urine drug tests at baseline, 2x weekly throughout the duration of the 6-week intervention, and at 3 months.

  3. Change in alcohol use screening status

    Time frame: Screening, Baseline, 3 months

    Participants will take the Alcohol Use Disorders Identification Test (AUDIT) at the time of screening, baseline and at 3 months. This is reported on a scale of 0-40; a higher score indicates a higher likelihood of moderate to severe alcohol use.

  4. Change in alcohol-related negative consequences

    Time frame: Baseline, 3 months

    Participants will take the Rutgers Alcohol Problems Index (RAPI) at baseline and at 3 months to assess changes in problems related to alcohol use. This is reported on a scale of 0-72; a higher score indicates a higher likelihood of alcohol-related negative consequences in everyday life.

  5. Change in alcohol use

    Time frame: Baseline, 3 months

    Participants will take the Timeline Follow Back (TLFB) questionnaire at baseline and at 3 months to assess changes in alcohol use.

  6. Change in reasons for drinking

    Time frame: Baseline, 3 months

    Participants will take the Drinking Motive Questionnaire-Revised (DMQ-R) at baseline and at 3 months to assess changes in alcohol use motivations. This is reported on a scale of 20-100; a higher score indicates stronger motivations for alcohol use.

Secondary outcomes

  1. Acceptability of intervention

    Time frame: 3 months

    Participants will complete a 10-minute interview at the end of the intervention to assess their sentiments towards CM-PST and take the Client Counseling Satisfaction Scale (CCSS). This is reported on a five-point Likert scale of 6-30, and includes an open-ended question about suggestions for future interventions. A higher score indicates a higher likelihood of participant satisfaction.

  2. Feasibility of intervention via adherence

    Time frame: 3 months

    Participant adherence will be assessed by monitoring and documenting attendance for each intervention session and completion of urine alcohol screening tests.

  3. Feasibility of intervention via retention

    Time frame: 3 months

    Participant retention will be assessed by monitoring and calculating the proportion of the study sample retained by the end of the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

Hagar Hallihan, PhD, RN

CONTACT

[email protected]

312-413-5361

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms (MOMS-AD Pilot Study)

Acronym: MOMS-AD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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