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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02883686
Other study ID # CO-16-2391
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 6, 2019
Est. completion date April 28, 2020

Study information

Verified date May 2020
Source University of Colorado, Boulder
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 27
Est. completion date April 28, 2020
Est. primary completion date April 28, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Alma
Alma peer-mentoring

Locations

Country Name City State
United States Kaiser Permanente of Colorado Aurora Colorado
United States University of Colorado Boulder Boulder Colorado

Sponsors (3)

Lead Sponsor Collaborator
University of Colorado, Boulder Emory University, Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Change in Perceived Stress Scale (PSS-10) score Self-report measure of stress. Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary 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
Secondary Parenting Stress Index-Short Form (PSI-4/SF) Self-reported stress in the parent-child system. 3-months postpartum
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Change in Self- Compassion Scale (SCS) score Self-report measure of self-compassion. Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary Mother Inventory of Reward Experiences (MIRE) Self-report questionnaire assessing reward responsivity in parenting. 3-months postpartum
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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