Randomized Controlled Trial of the Alma Peer Mentoring Program for Pregnant Women Experiencing Depression
- Conditions
- DepressionDepression, Postpartum
- Interventions
- Behavioral: Alma
- Registration Number
- NCT02883686
- Lead Sponsor
- University of Colorado, Boulder
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alma Mentoring plus usual care Alma Alma peer-mentoring
- Primary Outcome Measures
Name Time Method Change in Patient Health Questionnaire (PHQ-9) score Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum Self-report measure of depression symptoms.
- Secondary Outcome Measures
Name Time Method Client Satisfaction Questionnaire (CSQ-8) 12-weeks post-randomization 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.
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 Self-report measure of generalized anxiety symptoms.
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report measure of health, disability, and functioning.
Parenting Stress Index-Short Form (PSI-4/SF) 3-months postpartum Self-reported stress in the parent-child system.
Working Alliance Inventory - Short Form (Intervention group only) 12-weeks post-randomization Self-report questionnaire that assess participant's working alliance with their peer mentor.
Change in Effort-Expenditure for Rewards Task (EEfRT) performance Baseline, 12-weeks post-randomization, 3-months postpartum Computerized behavior task administered remotely that assesses effort-based decision-making.
Change in Go/No-Go Task (GNAT) performance Baseline, 12-weeks post-randomization, 3-months postpartum Computerized behavior task administered remotely that assesses implicit associations pairing the self with both stigma and belonging.
Change in Perceived Stress Scale (PSS-10) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report measure of stress.
Change in Behavioral Activation for Depression Scale (BADS) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report questionnaire that assesses activation in daily life: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.
Change in Reward-Probability Index (RPI) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report questionnaire that assess proxy dimensions of response-contingent positive reinforcement: reward probability and environmental suppressors inhibiting access to reinforcement.
Mother Inventory of Reward Experiences (MIRE) 3-months postpartum Self-report questionnaire assessing reward responsivity in parenting.
Change in Social Support Questionnaire - Short Form (SSQ-SF) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report questionnaire assessing social support available to a participant and their perception of the quality of that social support.
Exit Interview 3-months postpartum 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.
Change in Environmental Reward Observation Scale (EROS) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report questionnaire that assess the experience of environmental reward over the past several weeks.
Change in Attitudes Toward Motherhood (AToM) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report questionnaire that assess women's attitudes about motherhood, including beliefs related to others' judgments, beliefs about maternal responsibility, and maternal role idealization.
Change in Self- Compassion Scale (SCS) score Baseline, 12-weeks post-randomization, 3-months postpartum Self-report measure of self-compassion.
Change in Experience Sampling Survey response Baseline, 12-weeks post-randomization, 3-months postpartum Momentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.
Trial Locations
- Locations (2)
Kaiser Permanente of Colorado
🇺🇸Aurora, Colorado, United States
University of Colorado Boulder
🇺🇸Boulder, Colorado, United States