Online Collaborative Learning Intervention to Prevent Perinatal Depression

January 13, 2020 updated by: Jennifer Duffecy, University of Illinois at Chicago
The overarching aim of this project is to develop and pilot an innovative online intervention (Share) that integrates an Individual Internet Intervention (III) and an Internet Support Group (ISG) in preventing Postpartum Major Depression (PPMD). To establish that supportive accountability is a critical component of the intervention, Share will be compared to an III alone, and an ISG without the III components.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postpartum major depression (PPMD) occurs in approximately 7% of women in the first three months after childbirth and up to 22% of women over the first year postpartum. The impact of PPMD can be profound, including emotional distress, impairment in daily functioning and especially in caring for an infant for women as well as disturbances in infant development. The need for preventive interventions that are effective and widely accessible is clear and widely recognized.

While several psychological interventions to prevent PPMD have demonstrated efficacy, all of these interventions require women to be physically present at a treatment site at a particular time and day. There are numerous well established access barriers to traditional face-to-face psychological interventions, particularly for postpartum women facing the demands of childcare, including cost, transportation barriers, and time constraints, all of which make it impossible for the vast majority of women to participate in preventive care. The Internet offers great potential in extending mental health services to perinatal women because it directly circumvents these barriers.

Two broad classes of internet interventions have been evaluated within medicine generally, although to date there are no published evaluations of such interventions among perinatal women: Individual Internet Interventions (IIIs), which provide patients with access to web-based self-management programs, and Internet Support Groups (ISGs), which are usually centered around a discussion board or chat room. Meta-analyses suggest that IIIs are effective with acutely depressed patients when they include regular support by live coach (d=.61), but are much less effective when they are provided as a stand-alone treatment (d=.25). The enhanced efficacy of coach-supported IIIs appears to be due to the greater adherence to the intervention (e.g. more frequent usage) resulting from personal coach contact. The obvious drawbacks are cost and scalability: infrastructures for the training, oversight and payment of coaches must be implemented.

In contrast, ISGs provide a vehicle for peer support, and are very highly valued and commonly used by perinatal women. However, while adherence may be good, trials have found unmoderated ISGs to be ineffective at reducing distress and depression, Taken together, the efficacy of the IIIs and the adherence, flexibility, and potential for peer support in an ISG suggest that peers in a well-constructed ISG that encourages support and collaborative learning, could enhance adherence and outcomes of online self-management training programs. Learning these self-management skills have proven effective in face-to-face interventions to prevent depression among perinatal women.

This intervention, which we call "Share", is based upon a unique combination of two critical concepts:

  1. the capacity of IIIs to teach self-management skills; and
  2. the potential for ISGs to enhance adherence and contribute to effective learning.

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women who are:

  1. 18 years and older
  2. Pregnant and between 20 and 28 weeks gestation and for whom there is an expectation of a full 40 week gestation at the birth of their child
  3. Have a Patient Health Questionnaire (PHQ-9) score score between 5-14
  4. Have access to a broadband internet connection
  5. Are able to read and speak English

Exclusion Criteria:

Women who:

  1. Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  2. Are diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder or other diagnosis using the Mini International Neuropsychiatric Interview (MINI) for which participation in this trial is either inappropriate or dangerous
  3. Are currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
  4. Are suicidal (i.e., have ideation, plan, and intent)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-Directed
Access to the e-health intervention (an interactive website with didactic material and interactive tools) for participants to use at their own pace for 8 weeks (Self-Directed)
Behavioral: Self-Directed
Experimental: Share
Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share).
Behavioral: Share

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)
Time Frame: Week 20
Week 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Usability and satisfaction based on the USE measure
Time Frame: Week 20
Week 20
Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)
Time Frame: Week 20
Week 20
Site usage as measured by the number of logins to the site over the course of the intervention
Time Frame: Week 20
Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

National Institute of Mental Health (NIMH)
Northwestern University
University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2017

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

April 21, 2014

First Posted (Estimate)

April 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1181
  • 1R34MH102478-01 (U.S. NIH Grant/Contract)
  • 7R34MH102478-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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