Online Collaborative Learning Intervention to Prevent Perinatal Depression
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|ClinicalTrials.gov Identifier: NCT02121015|
Recruitment Status : Completed
First Posted : April 23, 2014
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression, Postpartum||Behavioral: Share Behavioral: Self-Directed||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Online Collaborative Learning Intervention to Prevent Perinatal Depression|
|Actual Study Start Date :||May 2016|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
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)
Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share).
- Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS) [ Time Frame: Week 20 ]
- Usability and satisfaction based on the USE measure [ Time Frame: Week 20 ]
- Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI) [ Time Frame: Week 20 ]
- Site usage as measured by the number of logins to the site over the course of the intervention [ Time Frame: Week 20 ]
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): NCT02121015
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Chicago, Illinois, United States|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States|
|Principal Investigator:||Jennifer Duffecy, PhD||University of Illinois at Chicago|