Health TrialsbyHealthPanel

Maternal Outcomes: Mood, Alcohol Use, and Depressive Symptoms

ConditionsPostpartum Depression (PPD)Alcohol UseContingency ManagementProblem Solving Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Illinois at Chicago

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biologically female

Age ≥18 years

Within 12 months postpartum

Able to provide informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Contingency Management & Problem Solving Therapy (CM-PST) Intervention GroupExperimental treatment 1 intervention
Group B: Usual Care Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Screening, Baseline, 3 months
2

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.

Time frame
Baseline, Weekly, 3 months
3

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.

Time frame
Screening, Baseline, 3 months
4

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.

Time frame
Baseline, 3 months

Secondary outcomes

1

Acceptability of intervention

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.

Time frame
3 months
2

Feasibility of intervention via adherence

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

Time frame
3 months
3

Feasibility of intervention via retention

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

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

Source ClinicalTrials.gov
Apply now