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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depression, Depression, Postpartum

Intervention / Treatment
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* Behavioral: Alma


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomly assigned to the Alma intervention or to Usual Care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alma Mentoring plus usual care<br>Alma peer-mentoring | Behavioral: Alma<br>* Alma peer-mentoring<br>|
| No Intervention: Enhanced Usual Care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal Depression, Postpartum Depression, Pregnancy, Peer-delivered, Task-sharing