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Trial record 9 of 1507 for:    depression AND (woman OR women OR female)

Mom for Moms Study: Peer Delivery of Behavioral Activation for Depression During Pregnancy (M4M)

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ClinicalTrials.gov Identifier: NCT02883686
Recruitment Status : Not yet recruiting
First Posted : August 30, 2016
Last Update Posted : August 30, 2016
Sponsor:
Collaborator:
Kaiser Permanente
Information provided by (Responsible Party):
University of Colorado, Boulder

Brief Summary:
Depression during pregnancy and postpartum is a major public health problem with adverse correlates and consequences for women and their children; although efficacious treatments for depression during pregnancy exist, few women receive such care. A widely recognized barrier to treatment engagement is the lack of effective, available care that is well aligned with women's treatment preferences. To close the gap between treatment need and receipt among depressed pregnant women, this study aims to develop and test the effectiveness of disseminating behavioral activation, an efficacious and acceptable treatment for depression, using peer delivery for pregnant women with depression.

Condition or disease Intervention/treatment Phase
Depression Pregnancy Behavioral: Peer-BA for Pregnant Women Behavioral: Care as Usual Not Applicable

Detailed Description:
Using a 3-phase structure, the study will: (1) refine the BA intervention for delivery by peers in obstetric settings, (2) develop and test web-based peer delivery training and fidelity tools, and (3) evaluate the feasibility, tolerability, acceptability, safety and preliminary effectiveness of BA peer delivery within community-based obstetric practice settings, and consistent with an experimental therapeutics approach, test the extent to which this delivery approach engages putative targets validated in prior studies of BA and explore novel targets potentially specific to peer delivery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Effectiveness of Disseminating Behavioral Activation Using Peer Delivery for Pregnant Women With Depression
Study Start Date : July 2017
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Peer-BA for Pregnant Women
Peer-delivered Behavioral Activation (BA) therapy for pregnant women
Behavioral: Peer-BA for Pregnant Women
Individual behavioral activation therapy sessions as delivered by trained peers
Behavioral: Care as Usual
Routine care plus ongoing screening, feedback, and referral to behavioral health services as indicated
Active Comparator: Care as Usual
Care as usual for depression at Kaiser Permanente (KP).
Behavioral: Care as Usual
Routine care plus ongoing screening, feedback, and referral to behavioral health services as indicated



Primary Outcome Measures :
  1. PHQ-9 Health Questionnaire (PHQ-9) [ Time Frame: Through 3 months postpartum ]
    Self-report measure to assess depressive severity and response


Secondary Outcome Measures :
  1. Client Satisfaction Questionnaire-8 [ Time Frame: At 3 months postpartum ]
    An eight item self-report measure of general satisfaction with BA peer delivery

  2. Generalized Anxiety Disorder 7-item (GAD-7) [ Time Frame: Through 3 months postpartum ]
    Self-report measure for anxiety

  3. Perceived Stress Scale (PSS-10) [ Time Frame: Through 3 months postpartum ]
    Self-report measure of perceived stress

  4. WHO Disability Assessment Schedule 2.0 (WHODAS2.0) [ Time Frame: Through 3 months postpartum ]
    Self-report assessment of functional status

  5. Behavioral Activation for Depression Scale - Short Form (BADS-SF) [ Time Frame: Through 3 months postpartum ]
    Measures extent of behavioral activation in daily life

  6. Environmental Reward Observation Scale (EROS) [ Time Frame: Through 3 months postpartum ]
    Measures the experience of environmental reward

  7. Effort-Expenditure for Rewards Task (EffRT) [ Time Frame: Through 3 months postpartum ]
    Measures behavioral performance on an effort-based decision making task

  8. Depression Self-Stigma Scale (DSSS) [ Time Frame: Through 3 months postpartum ]
    Measures perceived and self-stigma

  9. Self Compassion Scale (SCS) [ Time Frame: Through 3 months postpartum ]
    The Common Humanity and Isolation subscales of the (SCS) will be used to index perceived social belongingness

  10. Go-No-Go-Association-Task (GNAT) [ Time Frame: Through 3 months postpartum ]
    Measures changes in implicit perceptions of stigma and social belonging over the course of the intervention

  11. Reward-Probability Index [ Time Frame: Through 3 months postpartum ]
    Measures access to environmental reward

  12. Experience Sampling [ Time Frame: Through 3 months postpartum ]
    Measures daily experience of activity, reward, emotion, and sleep

  13. Pittsburgh Sleep Quality Index [ Time Frame: Through 3 months postpartum ]
    Assesses sleep quality and nighttime routine



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

STAKEHOLDERS (Phase 1):

Inclusion:

  • Any Kaiser Permanente Colorado (KPCO) staff providing or overseeing obstetric and behavioral health services, including obstetric and behavioral health clinical and administrative staff, and health plan managers.

Exclusion:

PATIENTS (Phase 1):

Inclusion:

  • KPCO members who are women
  • At least 18 years of age
  • History of depression during pregnancy or postpartum
  • Current Patient Health Questionnaire (PHQ-9) score of <10

Exclusion:

  • Lifetime diagnosis of bipolar or psychotic disorder, or active mania, psychosis, or substance abuse
  • Immediate risk of self-harm
  • Unable to speak and read English

PATIENTS (Phase 2-3):

Inclusion:

  • KPCO members who are pregnant women
  • At least 18 years of age
  • Baseline score of ≥ 10 on the Patient Health Questionnaire (PHQ-9)

Exclusion:

  • Lifetime diagnosis of bipolar or psychotic disorder, active mania, psychosis, or substance abuse
  • Immediate risk of self-harm
  • Unable to speak and read English

PEERS (Phase 2-3):

Inclusion:

  • KPCO members who are mothers
  • At least 18 years of age
  • At least high school education
  • A self-reported history and recovery from depression
  • An expressed desire to help people with mental health problems
  • Available for scheduled training, BA delivery, and peer supervision
  • Access to the internet for training and supervision

Exclusion:

  • Failure to demonstrate passing intervention quality during training
  • Baseline score of ≥ 10 on the Patient Health Questionnaire (PHQ-9)

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
Contact: Sona Dimidjian 3034923485 sona.dimidjian@colorado.edu

Locations
United States, Colorado
University of Colorado Boulder
Boulder, Colorado, United States, 80309
Sponsors and Collaborators
University of Colorado, Boulder
Kaiser Permanente

Responsible Party: 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 30, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators plan to comply with National Institute of Mental Health guidelines for data sharing.

Keywords provided by University of Colorado, Boulder:
depression
pregnancy
behavioral activation
peer delivery
effectiveness

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders