Online Collaborative Learning Intervention to Prevent Perinatal Depression
Primary Purpose
Depression, Postpartum
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Share
Self-Directed
Sponsored by
About this trial
This is an interventional prevention trial for Depression, Postpartum focused on measuring Postpartum Depression, Depression Prevention, Supportive Accountability, Individual Internet Interventions (IIIs), Internet Support Groups (ISGs)
Eligibility Criteria
Inclusion Criteria:
Women who are:
- 18 years and older
- 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
- Have a Patient Health Questionnaire (PHQ-9) score score between 5-14
- Have access to a broadband internet connection
- Are able to read and speak English
Exclusion Criteria:
Women who:
- Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- 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
- 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)
- Are suicidal (i.e., have ideation, plan, and intent)
Sites / Locations
- University of Illinois at Chicago
- Northwestern University
- University of Iowa
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Self-Directed
Share
Arm Description
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)
Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share).
Outcomes
Primary Outcome Measures
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)
Secondary Outcome Measures
Usability and satisfaction based on the USE measure
Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)
Site usage as measured by the number of logins to the site over the course of the intervention
Full Information
NCT ID
NCT02121015
First Posted
February 17, 2014
Last Updated
January 13, 2020
Sponsor
University of Illinois at Chicago
Collaborators
Northwestern University, University of Iowa, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT02121015
Brief Title
Online Collaborative Learning Intervention to Prevent Perinatal Depression
Official Title
Online Collaborative Learning Intervention to Prevent Perinatal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Northwestern University, University of Iowa, National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
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.
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:
the capacity of IIIs to teach self-management skills; and
the potential for ISGs to enhance adherence and contribute to effective learning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Postpartum
Keywords
Postpartum Depression, Depression Prevention, Supportive Accountability, Individual Internet Interventions (IIIs), Internet Support Groups (ISGs)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
210 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Directed
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Share
Arm Type
Experimental
Arm Description
Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share).
Intervention Type
Behavioral
Intervention Name(s)
Share
Intervention Type
Behavioral
Intervention Name(s)
Self-Directed
Primary Outcome Measure Information:
Title
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)
Time Frame
Week 20
Secondary Outcome Measure Information:
Title
Usability and satisfaction based on the USE measure
Time Frame
Week 20
Title
Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)
Time Frame
Week 20
Title
Site usage as measured by the number of logins to the site over the course of the intervention
Time Frame
Week 20
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women who are:
18 years and older
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
Have a Patient Health Questionnaire (PHQ-9) score score between 5-14
Have access to a broadband internet connection
Are able to read and speak English
Exclusion Criteria:
Women who:
Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
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
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)
Are suicidal (i.e., have ideation, plan, and intent)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Duffecy, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35654284
Citation
Duffecy J, Grekin R, Long JD, Mills JA, O'Hara M. Randomized controlled trial of Sunnyside: Individual versus group-based online interventions to prevent postpartum depression. J Affect Disord. 2022 Aug 15;311:538-547. doi: 10.1016/j.jad.2022.05.123. Epub 2022 May 30.
Results Reference
derived
PubMed Identifier
31140443
Citation
Duffecy J, Grekin R, Hinkel H, Gallivan N, Nelson G, O'Hara MW. A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial. JMIR Ment Health. 2019 May 28;6(5):e10778. doi: 10.2196/10778.
Results Reference
derived
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Online Collaborative Learning Intervention to Prevent Perinatal Depression
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