Online Collaborative Learning Intervention to Prevent Perinatal Depression

Depression, Postpartum Clinical Trial

Official title:

Online Collaborative Learning Intervention to Prevent Perinatal Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02121015
• Other study ID #: 2014-1181
• Secondary ID: 1R34MH102478-017
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: November 2017

Study information

• Verified date: January 2020
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• Share

• Self-Directed

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa

Sponsors (4)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Mental Health (NIMH), Northwestern University, University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)		Week 20
Secondary	Usability and satisfaction based on the USE measure		Week 20
Secondary	Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)		Week 20
Secondary	Site usage as measured by the number of logins to the site over the course of the intervention		Week 20