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

NCT02883686 | Completed DMC

• 1 other identifier: CO-16-2391
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression; Depression, Postpartum

Keywords

Perinatal Depression; Postpartum Depression; Pregnancy; Peer-delivered; Task-sharing

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire (PHQ-9) score

  Self-report measure of depression symptoms.

  Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum

Secondary Outcomes (17)

• Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score

  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

  Baseline, 12-weeks post-randomization, 3-months postpartum

• Change in WHO Disability Assessment Schedule (WHODAS 2.0) score

  Baseline, 12-weeks post-randomization, 3-months postpartum

• Parenting Stress Index-Short Form (PSI-4/SF)

  3-months postpartum

• Change in Behavioral Activation for Depression Scale (BADS) score

  Baseline, 12-weeks post-randomization, 3-months postpartum

Study Arms (2)

Alma Mentoring plus usual care

EXPERIMENTAL

Alma peer-mentoring

Behavioral: Alma

Enhanced Usual Care

NO INTERVENTION

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

Interventions

Alma BEHAVIORAL

Alma peer-mentoring

Alma Mentoring plus usual care

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• Kaiser Permanente: collaborator
• Emory University: collaborator

Study Sites (2)

Kaiser Permanente of Colorado

Aurora, Colorado, 80014, United States

Location

University of Colorado Boulder

Boulder, Colorado, 80309, United States

Location

Related Links

• Study information website for potential participants.

MeSH Terms

Conditions

Depression; Depression, Postpartum

Interventions

N(alpha)-acetyllysine-N-methylamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Sona Dimidjian, PhD

  University of Colorado, Boulder

  PRINCIPAL INVESTIGATOR

• Arne Beck, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomly assigned to the Alma intervention or to Usual Care

Study Record Dates

• First Submitted: August 3, 2016
• First Posted: August 30, 2016
• Study Start: February 6, 2019
• Primary Completion: April 28, 2020
• Study Completion: April 28, 2020
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)