Clinical trial NCT02883686: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Depression, Postpartum
Keywords: Perinatal Depression
Postpartum Depression
Pregnancy
Peer-delivered
Task-sharing
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: Kaiser Permanente
name: Emory University
First posted: 2016-08-30
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to the Alma intervention or to Usual Care
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Patient Health Questionnaire (PHQ-9) score
timeFrame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Secondary outcomes:
measure: Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
timeFrame: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
measure: Change in Perceived Stress Scale (PSS-10) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Parenting Stress Index-Short Form (PSI-4/SF)
timeFrame: 3-months postpartum
measure: Change in Behavioral Activation for Depression Scale (BADS) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in Reward-Probability Index (RPI) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in Environmental Reward Observation Scale (EROS) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in Attitudes Toward Motherhood (AToM) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Working Alliance Inventory - Short Form (Intervention group only)
timeFrame: 12-weeks post-randomization
measure: Change in Self- Compassion Scale (SCS) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Mother Inventory of Reward Experiences (MIRE)
timeFrame: 3-months postpartum
measure: Change in Social Support Questionnaire - Short Form (SSQ-SF) score
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 12-weeks post-randomization
measure: Change in Effort-Expenditure for Rewards Task (EEfRT) performance
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in Experience Sampling Survey response
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Change in Go/No-Go Task (GNAT) performance
timeFrame: Baseline, 12-weeks post-randomization, 3-months postpartum
measure: Exit Interview
timeFrame: 3-months postpartum
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente of Colorado
state: Colorado
city: Boulder
country: United States
facility: University of Colorado Boulder
state: Colorado
Study officials:
affiliation: University of Colorado, Boulder
name: Sona Dimidjian, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente
name: Arne Beck, PhD
role: PRINCIPAL_INVESTIGATOR
References: