Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

NCT07485036 | Not Yet Recruiting

• 1 other identifier: 2026-0112
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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

Conditions

Postpartum Depression (PPD); Alcohol Use; Contingency Management; Problem Solving Therapy

Outcome Measures

Primary Outcomes (6)

• Change in postpartum depression symptoms

  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.

  Screening, Baseline, 3 months

• Alcohol use test results

  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.

  Baseline, Weekly, 3 months

• Change in alcohol use screening status

  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.

  Screening, Baseline, 3 months

• Change in alcohol-related negative consequences

  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.

  Baseline, 3 months

• Change in alcohol use

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

  Baseline, 3 months

• Change in reasons for drinking

  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.

  Baseline, 3 months

Secondary Outcomes (3)

• Acceptability of intervention

  3 months

• Feasibility of intervention via adherence

  3 months

• Feasibility of intervention via retention

  3 months

Study Arms (2)

Contingency Management & Problem Solving Therapy (CM-PST) Intervention Group

EXPERIMENTAL

Receives 4 remote sessions of CM-PST therapy over 6 weeks while conducting at home urine drug tests 2x weekly.

Behavioral: Contingency Management & Problem Solving Therapy

Usual Care Control Group

PLACEBO COMPARATOR

Other: Usual Care

Interventions

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.

Contingency Management & Problem Solving Therapy (CM-PST) Intervention Group

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.

Usual Care Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

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

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Depression, Postpartum; Alcohol Drinking

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Drinking Behavior; Behavior

Central Study Contacts

Hagar Hallihan, PhD, RN

CONTACT

312-413-5361; hhalli2@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: March 20, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: After analyzing data.

Locations

US (1)