DepressionNCT02883686
Randomized Controlled Trial of the Alma Peer Mentoring Program for Pregnant Women Experiencing Depression
A study testing Alma in people with Depression and Depression, Postpartum, run by University of Colorado, Boulder at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Depression, Postpartum
- What is being tested?
- Alma
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Feb 2019to 28 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaiser Permanente of Colorado
Aurora, Colorado, 80014
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
Official title: The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With 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.
Read the 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.
- Conditions
- Depression, Depression, Postpartum
- Being tested
- Alma
- Keywords
- Perinatal Depression, Postpartum Depression, Pregnancy, Peer-delivered, Task-sharing
- Medical subject headings
- Depression, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlmaBehavioural
Alma peer-mentoring
| Study group | Role | What they receive |
|---|---|---|
| Alma Mentoring plus usual care | Experimental | Alma peer-mentoring Receives: Behavioral: Alma |
| Enhanced Usual Care | No intervention | Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Health Questionnaire (PHQ-9) score
Self-report measure of depression symptoms.
Measured: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Secondary outcomes (17)
Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score
Self-report measure of generalized anxiety symptoms.
Measured: Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Change in Perceived Stress Scale (PSS-10) score
Self-report measure of stress.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
Self-report measure of health, disability, and functioning.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Parenting Stress Index-Short Form (PSI-4/SF)
Self-reported stress in the parent-child system.
Measured: 3-months postpartum
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.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
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.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Environmental Reward Observation Scale (EROS) score
Self-report questionnaire that assess the experience of environmental reward over the past several weeks.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
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.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Working Alliance Inventory - Short Form (Intervention group only)
Self-report questionnaire that assess participant's working alliance with their peer mentor.
Measured: 12-weeks post-randomization
Change in Self- Compassion Scale (SCS) score
Self-report measure of self-compassion.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Mother Inventory of Reward Experiences (MIRE)
Self-report questionnaire assessing reward responsivity in parenting.
Measured: 3-months postpartum
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.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
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.
Measured: 12-weeks post-randomization
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Computerized behavior task administered remotely that assesses effort-based decision-making.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Experience Sampling Survey response
Momentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
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.
Measured: Baseline, 12-weeks post-randomization, 3-months postpartum
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.
Measured: 3-months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study start6 Feb 2019
- Primary completion28 Apr 2020
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to the Alma intervention or to Usual Care
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Boulder
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Emory University
- Responsible party
- Principal investigator, Sona Dimidjian, University of Colorado, Boulder
- Investigators
- Sona Dimidjian, PhD, Principal investigator, University of Colorado, BoulderArne Beck, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883686
- Sponsor's protocol ID
- CO-16-2391
- Status last verified
- May 2020
- First submitted
- 3 Aug 2016
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression
- ClinicalTrials.gov ID
- NCT02883686
- Acronym / sponsor ID
- CO-16-2391
- Conditions
- Depression, Depression, Postpartum
- Keywords
- Perinatal Depression, Postpartum Depression, Pregnancy, Peer-delivered, Task-sharing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Colorado, BoulderUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Emory University
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 28 Apr 2020 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 30 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to the Alma intervention or to Usual Care
| Arm | Type | Receives |
|---|---|---|
| Alma Mentoring plus usual care | Experimental | Behavioral: AlmaAlma peer-mentoring |
| Enhanced Usual Care | No intervention | –Usual care for depression within the Kaiser Permanente of Colorado healthcare system plus study monitoring of depression symptoms and feedback. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlmaAlma peer-mentoring | Behavioural | Alma Mentoring plus usual care |
Primary outcome
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.
17 secondary outcomes
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
Change in Perceived Stress Scale (PSS-10) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in WHO Disability Assessment Schedule (WHODAS 2.0) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Parenting Stress Index-Short Form (PSI-4/SF)
Time frame: 3-months postpartum
Change in Behavioral Activation for Depression Scale (BADS) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Reward-Probability Index (RPI) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Environmental Reward Observation Scale (EROS) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Attitudes Toward Motherhood (AToM) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Working Alliance Inventory - Short Form (Intervention group only)
Time frame: 12-weeks post-randomization
Change in Self- Compassion Scale (SCS) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Mother Inventory of Reward Experiences (MIRE)
Time frame: 3-months postpartum
Change in Social Support Questionnaire - Short Form (SSQ-SF) score
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 12-weeks post-randomization
Change in Effort-Expenditure for Rewards Task (EEfRT) performance
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Experience Sampling Survey response
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Change in Go/No-Go Task (GNAT) performance
Time frame: Baseline, 12-weeks post-randomization, 3-months postpartum
Exit Interview
Time frame: 3-months postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Study information website for potential participants.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sona Dimidjian, PhD principal investigator
University of Colorado, Boulder
Arne Beck, PhD principal investigator
Kaiser Permanente
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alma in people with Depression and Depression, Postpartum, run by University of Colorado, Boulder at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.