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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02883686
Enrollment
27
Registered
2016-08-30
Start date
2019-02-06
Completion date
2020-04-28
Last updated
2020-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Depression, Postpartum

Keywords

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

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.

Interventions

BEHAVIORALAlma

Alma peer-mentoring

Sponsors

Kaiser Permanente
CollaboratorOTHER
Emory University
CollaboratorOTHER
University of Colorado, Boulder
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants are randomly assigned to the Alma intervention or to Usual Care

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Patient Health Questionnaire (PHQ-9) scoreEvery 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartumSelf-report measure of depression symptoms.

Secondary

MeasureTime frameDescription
Change in Perceived Stress Scale (PSS-10) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report measure of stress.
Change in WHO Disability Assessment Schedule (WHODAS 2.0) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report measure of health, disability, and functioning.
Parenting Stress Index-Short Form (PSI-4/SF)3-months postpartumSelf-reported stress in the parent-child system.
Change in Behavioral Activation for Depression Scale (BADS) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report questionnaire that assesses activation in daily life: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
Change in Reward-Probability Index (RPI) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report questionnaire that assess proxy dimensions of response-contingent positive reinforcement: reward probability and environmental suppressors inhibiting access to reinforcement.
Change in Environmental Reward Observation Scale (EROS) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report questionnaire that assess the experience of environmental reward over the past several weeks.
Change in Attitudes Toward Motherhood (AToM) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report questionnaire that assess women's attitudes about motherhood, including beliefs related to others' judgments, beliefs about maternal responsibility, and maternal role idealization.
Working Alliance Inventory - Short Form (Intervention group only)12-weeks post-randomizationSelf-report questionnaire that assess participant's working alliance with their peer mentor.
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) scoreEvery 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartumSelf-report measure of generalized anxiety symptoms.
Mother Inventory of Reward Experiences (MIRE)3-months postpartumSelf-report questionnaire assessing reward responsivity in parenting.
Change in Social Support Questionnaire - Short Form (SSQ-SF) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report questionnaire assessing social support available to a participant and their perception of the quality of that social support.
Client Satisfaction Questionnaire (CSQ-8)12-weeks post-randomizationSelf-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.
Change in Effort-Expenditure for Rewards Task (EEfRT) performanceBaseline, 12-weeks post-randomization, 3-months postpartumComputerized behavior task administered remotely that assesses effort-based decision-making.
Change in Experience Sampling Survey responseBaseline, 12-weeks post-randomization, 3-months postpartumMomentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.
Change in Go/No-Go Task (GNAT) performanceBaseline, 12-weeks post-randomization, 3-months postpartumComputerized behavior task administered remotely that assesses implicit associations pairing the self with both stigma and belonging.
Exit Interview3-months postpartumAn 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.
Change in Self- Compassion Scale (SCS) scoreBaseline, 12-weeks post-randomization, 3-months postpartumSelf-report measure of self-compassion.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026