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

Primary Purpose

Depression, Depression, Postpartum

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alma
Sponsored by
University of Colorado, Boulder
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Perinatal Depression, Postpartum Depression, Pregnancy, Peer-delivered, Task-sharing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente of Colorado
  • University of Colorado Boulder

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alma Mentoring plus usual care

Enhanced Usual Care

Arm Description

Alma peer-mentoring

Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.

Outcomes

Primary Outcome Measures

Change in Patient Health Questionnaire (PHQ-9) score
Self-report measure of depression symptoms.

Secondary Outcome Measures

Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
Self-report measure of generalized anxiety symptoms.
Change in Perceived Stress Scale (PSS-10) score
Self-report measure of stress.
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
Self-report measure of health, disability, and functioning.
Parenting Stress Index-Short Form (PSI-4/SF)
Self-reported stress in the parent-child system.
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.
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.
Change in Environmental Reward Observation Scale (EROS) score
Self-report questionnaire that assess the experience of environmental reward over the past several weeks.
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.
Working Alliance Inventory - Short Form (Intervention group only)
Self-report questionnaire that assess participant's working alliance with their peer mentor.
Change in Self- Compassion Scale (SCS) score
Self-report measure of self-compassion.
Mother Inventory of Reward Experiences (MIRE)
Self-report questionnaire assessing reward responsivity in parenting.
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.
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.
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Computerized behavior task administered remotely that assesses effort-based decision-making.
Change in Experience Sampling Survey response
Momentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.
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.
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.

Full Information

First Posted
August 3, 2016
Last Updated
May 4, 2020
Sponsor
University of Colorado, Boulder
Collaborators
Kaiser Permanente, Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT02883686
Brief Title
Randomized Controlled Trial of the Alma Peer Mentoring Program for Pregnant Women Experiencing Depression
Official Title
The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
April 28, 2020 (Actual)
Study Completion Date
April 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Colorado, Boulder
Collaborators
Kaiser Permanente, Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depression, Postpartum
Keywords
Perinatal Depression, Postpartum Depression, Pregnancy, Peer-delivered, Task-sharing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly assigned to the Alma intervention or to Usual Care
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alma Mentoring plus usual care
Arm Type
Experimental
Arm Description
Alma peer-mentoring
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.
Intervention Type
Behavioral
Intervention Name(s)
Alma
Intervention Description
Alma peer-mentoring
Primary Outcome Measure Information:
Title
Change in Patient Health Questionnaire (PHQ-9) score
Description
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
Secondary Outcome Measure Information:
Title
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
Description
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
Title
Change in Perceived Stress Scale (PSS-10) score
Description
Self-report measure of stress.
Time Frame
Baseline, 12-weeks post-randomization, 3-months postpartum
Title
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
Description
Self-report measure of health, disability, and functioning.
Time Frame
Baseline, 12-weeks post-randomization, 3-months postpartum
Title
Parenting Stress Index-Short Form (PSI-4/SF)
Description
Self-reported stress in the parent-child system.
Time Frame
3-months postpartum
Title
Change in Behavioral Activation for Depression Scale (BADS) score
Description
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
Title
Change in Reward-Probability Index (RPI) score
Description
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
Title
Change in Environmental Reward Observation Scale (EROS) score
Description
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
Title
Change in Attitudes Toward Motherhood (AToM) score
Description
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
Title
Working Alliance Inventory - Short Form (Intervention group only)
Description
Self-report questionnaire that assess participant's working alliance with their peer mentor.
Time Frame
12-weeks post-randomization
Title
Change in Self- Compassion Scale (SCS) score
Description
Self-report measure of self-compassion.
Time Frame
Baseline, 12-weeks post-randomization, 3-months postpartum
Title
Mother Inventory of Reward Experiences (MIRE)
Description
Self-report questionnaire assessing reward responsivity in parenting.
Time Frame
3-months postpartum
Title
Change in Social Support Questionnaire - Short Form (SSQ-SF) score
Description
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
Title
Client Satisfaction Questionnaire (CSQ-8)
Description
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
Title
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Description
Computerized behavior task administered remotely that assesses effort-based decision-making.
Time Frame
Baseline, 12-weeks post-randomization, 3-months postpartum
Title
Change in Experience Sampling Survey response
Description
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
Title
Change in Go/No-Go Task (GNAT) performance
Description
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
Title
Exit Interview
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sona Dimidjian, PhD
Organizational Affiliation
University of Colorado, Boulder
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arne Beck, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
University of Colorado Boulder
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://almastudy.kp.org/
Description
Study information website for potential participants.

Learn more about this trial

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

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