Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02883686
Recruitment Status : Recruiting
First Posted : August 30, 2016
Last Update Posted : August 16, 2019
Sponsor:
Collaborators:
Kaiser Permanente
Emory University
Information provided by (Responsible Party):
Sona Dimidjian, 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.

Condition or disease Intervention/treatment Phase
Depression Depression, Postpartum Behavioral: Alma Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomly assigned to the Alma intervention or to Usual Care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Alma Mentoring plus usual care
Alma peer-mentoring
Behavioral: Alma
Alma peer-mentoring

No Intervention: Enhanced Usual Care
Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02883686


Contacts
Layout table for location contacts
Contact: Elizabeth Lemon, MA 720-722-1441 elizabeth.lemon@colorado.edu
Contact: Megan Baldwin 720-697-4754 alma@kp.org

Locations
Layout table for location information
United States, Colorado
Kaiser Permanente of Colorado Recruiting
Aurora, Colorado, United States, 80014
Contact: Megan Baldwin    720-697-4754    alma@kp.org   
Contact: Elizabeth Lemon, MA    720-722-1441    elizabeth.lemon@colorado.edu   
Principal Investigator: Arne Beck, PhD         
University of Colorado Boulder Recruiting
Boulder, Colorado, United States, 80309
Contact: Elizabeth Lemon, MA    720-722-1441    elizabeth.lemon@colorado.edu   
Contact: Megan Baldwin    720-697-4754    alma@kp.org   
Principal Investigator: Sona Dimidjian, PhD         
Sponsors and Collaborators
University of Colorado, Boulder
Kaiser Permanente
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Sona Dimidjian, PhD University of Colorado, Boulder
Principal Investigator: Arne Beck, PhD Kaiser Permanente

Additional Information:
Layout table for additonal information
Responsible Party: Sona Dimidjian, Professor, University of Colorado, Boulder
ClinicalTrials.gov Identifier: NCT02883686     History of Changes
Other Study ID Numbers: CO-16-2391
First Posted: August 30, 2016    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sona Dimidjian, University of Colorado, Boulder:
Perinatal Depression
Postpartum Depression
Pregnancy
Peer-delivered
Task-sharing
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications