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

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: Completed
• Conditions: Depression; Depression, Postpartum
• Intervention / Treatment: Behavioral: Alma

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: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score	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	Self-report measure of stress.	Baseline, 12-weeks post-randomization, 3-months postpartum
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score	Self-report measure of health, disability, and functioning.	Baseline, 12-weeks post-randomization, 3-months postpartum
Parenting Stress Index-Short Form (PSI-4/SF)	Self-reported stress in the parent-child system.	3-months postpartum
Change in Behavioral Activation for Depression Scale (BADS) score	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	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	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	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)	Self-report questionnaire that assess participant's working alliance with their peer mentor.	12-weeks post-randomization
Change in Self- Compassion Scale (SCS) score	Self-report measure of self-compassion.	Baseline, 12-weeks post-randomization, 3-months postpartum
Mother Inventory of Reward Experiences (MIRE)	Self-report questionnaire assessing reward responsivity in parenting.	3-months postpartum
Change in Social Support Questionnaire - Short Form (SSQ-SF) score	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)	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	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	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	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	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

• Sponsor: University of Colorado, Boulder
• Collaborators: Emory University; Kaiser Permanente
• Investigators: Principal Investigator: Arne Beck, PhD, Kaiser Permanente; Principal Investigator: Sona Dimidjian, PhD, University of Colorado, Boulder

Publications and helpful links

Helpful Links

• Study information website for potential participants.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): April 28, 2020
• Study Completion (Actual): April 28, 2020

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Postpartum Depression; Pregnancy; Perinatal Depression; Peer-delivered; Task-sharing
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID 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