An interventional study of Alma in Depression and Depression, Postpartum, sponsored by University of Colorado, Boulder. Completed at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-06.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Treatment
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.
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 27 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →University of Colorado, Boulder is the lead sponsor of 86 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alma peer-mentoring
Behavioral: Alma
Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.
Alma peer-mentoring
Change in Patient Health Questionnaire (PHQ-9) score
Self-report measure of depression symptoms.
Time frame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
Self-report measure of generalized anxiety symptoms.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Parenting Stress Index-Short Form (PSI-4/SF)
Self-reported stress in the parent-child system.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks post-randomization
Change in Self- Compassion Scale (SCS) score
Self-report measure of self-compassion.
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Mother Inventory of Reward Experiences (MIRE)
Self-report questionnaire assessing reward responsivity in parenting.
Time frame: 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.
Time frame: 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.
Time frame: 12-weeks post-randomization
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Computerized behavior task administered remotely that assesses effort-based decision-making.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-months postpartum
Plan to share: No
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University of Colorado, Boulder