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

NCT ID: NCT02883686

Last Updated: 2020-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2020-04-28

Brief Summary

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.

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.

Conditions

Depression; Depression, Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alma Mentoring plus usual care

Alma peer-mentoring

Group Type: EXPERIMENTAL

Alma

Intervention Type: BEHAVIORAL

Alma peer-mentoring

Enhanced Usual Care

Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Alma

Alma peer-mentoring

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: collaborator

University of Colorado, Boulder

OTHER

Sponsor Role: lead

Responsible Party

Sona Dimidjian

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sona Dimidjian, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Boulder

Arne Beck, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Kaiser Permanente of Colorado

Aurora, Colorado, United States

University of Colorado Boulder

Boulder, Colorado, United States

Countries

United States

Related Links

http://almastudy.kp.org/

Study information website for potential participants.

Other Identifiers

CO-16-2391

Identifier Type: -

Identifier Source: org_study_id