Depression, PostpartumNCT02121015
Online Collaborative Learning Intervention to Prevent Perinatal Depression
A study testing Share and Self-Directed in people with Depression, Postpartum, run by University of Illinois Chicago at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum
- What is being tested?
- Share and Self-Directed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Illinois at Chicago
Chicago, Illinois, 60612
Northwestern University
Chicago, Illinois
University of Iowa
Iowa City, Iowa
About this study
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.
Read the 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.
- Conditions
- Depression, Postpartum
- Being tested
- Share, Self-Directed
- Keywords
- Postpartum Depression, Depression Prevention, Supportive Accountability, Individual Internet Interventions (IIIs), Internet Support Groups (ISGs)
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShareBehavioural
Self-DirectedBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Self-Directed | Active comparator | 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) Receives: Behavioral: Self-Directed |
| Share | Experimental | Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share). Receives: Behavioral: Share |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)
Measured: Week 20
Secondary outcomes (3)
Usability and satisfaction based on the USE measure
Measured: Week 20
Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)
Measured: Week 20
Site usage as measured by the number of logins to the site over the course of the intervention
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2014 (estimated)
- Study startMay 2016
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, PostpartumStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, University of Iowa, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Jennifer Duffecy, University of Illinois Chicago
- Investigators
- Jennifer Duffecy, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02121015
- Sponsor's protocol ID
- 2014-1181
- Other IDs
- 1R34MH102478-01, 7R34MH102478-02
- Status last verified
- Jan 2020
- First submitted
- 17 Feb 2014
- Last updated
- 18 Jan 2020
- Results posted
- No
Publications
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.
PubMed 35654284Duffecy 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.
PubMed 31140443
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Collaborative Learning Intervention to Prevent Perinatal Depression
- ClinicalTrials.gov ID
- NCT02121015
- Acronym / sponsor ID
- 2014-1181
- Conditions
- Depression, Postpartum
- Keywords
- Postpartum Depression, Depression Prevention, Supportive Accountability, Individual Internet Interventions (IIIs), Internet Support Groups (ISGs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University, University of Iowa, National Institute of Mental Health (NIMH)
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 23 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Directed | Active comparator | Behavioral: Self-DirectedAccess 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) |
| Share | Experimental | Behavioral: ShareAccess to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Share | Behavioural | Share |
| Self-Directed | Behavioural | Self-Directed |
Primary outcome
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)
Time frame: Week 20
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 35654284Duffecy 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.
- Derived from this study: PubMed 31140443Duffecy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Duffecy, PhD principal investigator
University of Illinois Chicago
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Share and Self-Directed in people with Depression, Postpartum, run by University of Illinois Chicago at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS) (time frame: Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02121015, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.