Randomized Controlled Trial of the Alma Peer Mentoring Program for Pregnant Women Experiencing Depression

May 4, 2020 updated by: Sona Dimidjian, University of Colorado, Boulder

The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help. Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer mentors do not provide psychotherapy and are not licensed mental health providers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help.

Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. We call this program Alma because the meaning of the word, in English and Spanish, captures what we hope moms will feel when they connect with this program. In English, the meaning comes from the Latin word for "nourishing" and "kind," and in Spanish, the meaning is "soul." Through the unique synergy of science and community, the Alma program provides the tools and support needed to nourish moms in supporting their own well-being.

In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained to provide 6-10 mentoring meetings with each of the new and expectant mothers with whom they are paired. The peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer Mentors are trained to support and encourage self-monitoring, scheduling activities, solving problems, and bridging to informal and formal professional support. Peer mentors draw on their training and own lived experience to provide hope and reduce the social isolation and stigma associated with perinatal depression. Among the evidence-based approaches to help people recover from depression, Alma uses BA as a lens because many studies have demonstrated that these skills are effective in recovering from depression. It has been provided in a self-guided format and by lay counselors and licensed mental health providers. Peer mentors do not provide psychotherapy and are not licensed mental health providers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80014
        • Kaiser Permanente of Colorado
      • Boulder, Colorado, United States, 80309
        • University of Colorado Boulder

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Currently enrolled member of Kaiser Permanente of Colorado (KPCO)
  • Current PHQ-9 score greater than or equal to 10
  • Current Columbia-Suicide Severity Rating Scale (C-SSRS) score less than 3
  • Currently pregnant

Exclusion Criteria:

  • Lifetime diagnosis of bipolar disorder or psychotic symptoms
  • Dementia or cognitive impairment disorder recorded in the medical record
  • Current substance abuse behavior
  • At immediate risk of self-harm
  • Unable to speak and read English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Alma Mentoring plus usual care
Alma peer-mentoring
Behavioral: Alma
Alma peer-mentoring
No Intervention: Enhanced Usual Care
Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Patient Health Questionnaire (PHQ-9) score
Time Frame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Self-report measure of depression symptoms.
Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
Time Frame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Self-report measure of generalized anxiety symptoms.
Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Change in Perceived Stress Scale (PSS-10) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report measure of stress.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report measure of health, disability, and functioning.
Baseline, 12-weeks post-randomization, 3-months postpartum
Parenting Stress Index-Short Form (PSI-4/SF)
Time Frame: 3-months postpartum
Self-reported stress in the parent-child system.
3-months postpartum
Change in Behavioral Activation for Depression Scale (BADS) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report questionnaire that assesses activation in daily life: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Reward-Probability Index (RPI) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report questionnaire that assess proxy dimensions of response-contingent positive reinforcement: reward probability and environmental suppressors inhibiting access to reinforcement.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Environmental Reward Observation Scale (EROS) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report questionnaire that assess the experience of environmental reward over the past several weeks.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Attitudes Toward Motherhood (AToM) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report questionnaire that assess women's attitudes about motherhood, including beliefs related to others' judgments, beliefs about maternal responsibility, and maternal role idealization.
Baseline, 12-weeks post-randomization, 3-months postpartum
Working Alliance Inventory - Short Form (Intervention group only)
Time Frame: 12-weeks post-randomization
Self-report questionnaire that assess participant's working alliance with their peer mentor.
12-weeks post-randomization
Change in Self- Compassion Scale (SCS) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report measure of self-compassion.
Baseline, 12-weeks post-randomization, 3-months postpartum
Mother Inventory of Reward Experiences (MIRE)
Time Frame: 3-months postpartum
Self-report questionnaire assessing reward responsivity in parenting.
3-months postpartum
Change in Social Support Questionnaire - Short Form (SSQ-SF) score
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Self-report questionnaire assessing social support available to a participant and their perception of the quality of that social support.
Baseline, 12-weeks post-randomization, 3-months postpartum
Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 12-weeks post-randomization
Self-report measure of general satisfaction with the Alma program. Participants randomized to treatment as usual will receive a CSQ-8 to measure general satisfaction with Kaiser Permanente of Colorado mental health services.
12-weeks post-randomization
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Computerized behavior task administered remotely that assesses effort-based decision-making.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Experience Sampling Survey response
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Momentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.
Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Go/No-Go Task (GNAT) performance
Time Frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Computerized behavior task administered remotely that assesses implicit associations pairing the self with both stigma and belonging.
Baseline, 12-weeks post-randomization, 3-months postpartum
Exit Interview
Time Frame: 3-months postpartum
An Exit Interview will be administered to solicit participant feedback about the Alma program and recommendations for improvement, including questions about overall program and specific Alma components, including telephone- or videoconference- based delivery, length and number of sessions, spacing between sessions, peer characteristics, and ease of access to peers.
3-months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Emory University
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arne Beck, PhD, Kaiser Permanente
  • Principal Investigator: Sona Dimidjian, PhD, University of Colorado, Boulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CO-16-2391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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