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Trial record 63 of 190 for:    Postpartum Depression AND women | "Depression" AND "Depression"

Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression

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ClinicalTrials.gov Identifier: NCT02979444
Recruitment Status : Recruiting
First Posted : December 1, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Darius Tandon, Northwestern University

Brief Summary:
There is considerable evidence that most perinatal women at risk for postpartum depression do not engage in mental health services, even when referred by home visiting (HV) programs, primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be delivered via alternative settings—e.g., HV programs—are essential to prevent the onset of major depression and worsening of depressive symptoms among perinatal women. This Patient Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is more efficacious than usual care (i.e., home visiting without the MB enhancement). It will also examine if MB, when led by paraprofessional home visitors, is not inferior to MB delivered by mental health professionals. The results of this study will inform decision-making by HV programs regarding provision of MB to perinatal women at risk for developing major depression.

Condition or disease Intervention/treatment Phase
Perinatal Depression PostPartum Depression Behavioral: Mothers and Babies Groups Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1680 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression
Study Start Date : August 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mothers and Babies Groups Home-Visitor
Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.
Behavioral: Mothers and Babies Groups
The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood.

Experimental: Mothers and Babies Groups Clinician
Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.
Behavioral: Mothers and Babies Groups
The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood.

No Intervention: Control
Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.



Primary Outcome Measures :
  1. The change in QIDS-16 scores [ Time Frame: Baseline and 12 and 24-week postpartum follow-up ]
    The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have >85% power to detect a difference difference in mean QIDS-16 scores of two points between the two arms.


Secondary Outcome Measures :
  1. The change in the Behavioral Activation Scale [ Time Frame: Baseline and 12 and 24-week postpartum follow-ups ]
    Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).

  2. The change in the Pleasant Activities Schedule [ Time Frame: Baseline and 12 and 24-week postpartum follow-ups ]
    Pleasant Activities will be measured using a checklist adapted from the Pleasant Events Schedule (PES; MacPhillamy & Lewinsohn, 1982). The original PES is a behavioral self-report measure on which respondents rate 320 pleasant events with respect to how frequently they occurred over the past month ["has not happened" (0) to "happened often" (3)] and how pleasant they were ["not pleasant" (0) to "very pleasant" (3)]. The measure was found to have strong psychometric properties, including concurrent and predictive validity (MacPhillamy & Lewinsohn, 1982). In this study, we will use a brief (~25 item) form of this checklist that includes pleasant events relevant for low-income pregnant women.

  3. The change in the Negative Mood Regulation Scale [ Time Frame: Baseline and 12 and 24-week postpartum follow-ups ]
    Mood regulation will be measured using the Negative Mood Regulation Scale (NMRS) (Catanzaro & Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood.

  4. The change in the MOS Social Support Survey [ Time Frame: Baseline and 12 and 24-week follow-ups ]
    Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction.

  5. The change in the Experiences Questionnaire [ Time Frame: Baseline and 12 and 24-week follow-ups ]
    Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The investigators will enroll only pregnant women in this study, given that the Mothers and Babies Course is delivered prenatally as a postpartum depression prevention intervention. The investigators will offer participation to prenatal home visiting clients, ages 16 and older, knowing the client base for home visiting programs includes pregnant teens.

Exclusion Criteria:

  • Women with high-risk medical and pregnancy conditions will be excluded since this may preclude women from regularly attending intervention sessions. The investigators will not exclude women based on race/ethnicity or based on demographic characteristics other than the ability to speak English or Spanish.

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): NCT02979444


Contacts
Contact: Jessica K Jensen, MPH 312-503-6808 jessica.jensen@northwestern.edu
Contact: Alicia Diebold, MSW 312-503-4817 alicia.diebold@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jessica K Jensen, MPH    312-503-6808    jessica.jensen@northwestern.edu   
Contact: Alicia Diebold, MSW    312-503-4817    alicia.diebold@northwestern.edu   
Principal Investigator: Darius Tandon, PhD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Darius Tandon, PhD Northwestern University

Additional Information:
Publications:
Kanter, J.W., Mulick, P.S., Busch, A.M., Berlin, K.S., & Martell, C.R. (2007). The Behavioral Activation for Depression Scale (BADS): Psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment, 29, 191-202.
Kanter, J.W., Rusch, L.C., Busch, A.M., & Sedivy, S.K. (2009). Validation of the behavioral activation for depression scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment, 31, 36-42.
MacPhillamy, D.J., & Lewinsohn, P.M. (1982). The pleasant events schedule: Studies on reliability, validity, and scale intercorrelation. Journal of Consulting and Clinical Psychology, 50(3), 363-380.
O'Hara, M., & Swain, A. (1996). Rates and risk of postpartum depression: A meta-analysis. International Review of Psychiatry, 8, 37-54.

Responsible Party: Darius Tandon, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02979444     History of Changes
Other Study ID Numbers: STU00203761
First Posted: December 1, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Asphyxia Neonatorum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Infant, Newborn, Diseases