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Completed

NCT Number: NCT02883686

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente of Colorado, Aurora, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alma

Behavioral

Alma peer-mentoring

Primary outcomes

  1. Change in Patient Health Questionnaire (PHQ-9) score

    Time frame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum

    Self-report measure of depression symptoms.

Secondary outcomes

  1. Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score

    Time frame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum

    Self-report measure of generalized anxiety symptoms.

  2. Change in Perceived Stress Scale (PSS-10) score

    Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum

    Self-report measure of stress.

  3. Change in WHO Disability Assessment Schedule (WHODAS 2.0) score

    Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum

    Self-report measure of health, disability, and functioning.

  4. Parenting Stress Index-Short Form (PSI-4/SF)

    Time frame: 3-months postpartum

    Self-reported stress in the parent-child system.

  5. Change in Behavioral Activation for Depression Scale (BADS) score

    Time frame: 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.

  6. Change in Reward-Probability Index (RPI) score

    Time frame: 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.

  7. Change in Environmental Reward Observation Scale (EROS) score

    Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum

    Self-report questionnaire that assess the experience of environmental reward over the past several weeks.

  8. Change in Attitudes Toward Motherhood (AToM) score

    Time frame: 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.

  9. Working Alliance Inventory - Short Form (Intervention group only)

    Time frame: 12-weeks post-randomization

    Self-report questionnaire that assess participant's working alliance with their peer mentor.

  10. Change in Self- Compassion Scale (SCS) score

    Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum

    Self-report measure of self-compassion.

  11. Mother Inventory of Reward Experiences (MIRE)

    Time frame: 3-months postpartum

    Self-report questionnaire assessing reward responsivity in parenting.

  12. Change in Social Support Questionnaire - Short Form (SSQ-SF) score

    Time frame: 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.

  13. Client Satisfaction Questionnaire (CSQ-8)

    Time frame: 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.

  14. Change in Effort-Expenditure for Rewards Task (EEfRT) performance

    Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum

    Computerized behavior task administered remotely that assesses effort-based decision-making.

  15. Change in Experience Sampling Survey response

    Time frame: 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.

  16. Change in Go/No-Go Task (GNAT) performance

    Time frame: 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.

  17. Exit Interview

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Collaborators

  • Emory University
  • Kaiser Permanente

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2016
Registry last updated
May 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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