An interventional study of Online self-help course plus live follow-up if needed and Online + incentives Follow-up Group in Major Depression, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-15.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
The purpose of the study is:
NOTE: RECRUITMENT IS COMPLETED.
In 2002, NIMH released an initiative that called upon researchers to improve psychosocial interventions for unipolar and bipolar depression. The Workgroup charged with this task recommended that researchers consider the "development of interventions that PREVENT onset and recurrence of clinical episodes in at-risk populations and [the] development of user-friendly interventions and nontraditional delivery methods to increase access to evidence-based interventions" (Hollon et al., 2002, p. 610). The overall goal of this research program aims to address these two priorities by adapting an empirically-validated depression intervention to the Internet. The current research study will eventually provide an online site to study whether clinical episodes of depression can be prevented by making the online Website available to people who are NOT currently depressed, but may be at risk for depression.
Study 1: the NIMH-funded pilot study. For Study 1, the investigators will conduct usability testing with 60 participants (half English-speaking and half Spanish-speaking) recruited at San Francisco General Hospital with the sole purpose of providing feedback on the Healthy Mood Management Project Website being developed. The investigators will not be testing the intervention itself on these usability testing participants.
The investigators will then recruit 150 participants (half English-speaking [NOW COMPLETED] and half Spanish-speaking [STILL RECRUITING]) WHO ARE NOT CURRENTLY DEPRESSED to use the Healthy Mood Management Project Website online. In this part of the study the investigators will compare follow-up completion rates obtained by (email reminders + monetary incentives) versus (email reminders + monetary incentives + phone call follow-ups). All participants will get automatic email reminders with links to return to the study site to fill out FU surveys at 1, 3, and 6 months. All participants will also be offered monetary incentives that can be obtained online. In addition, half of the participants (chosen at random) will receive phone calls if they do not complete follow-up surveys online. This will allow us to determine whether the phone call follow-ups significantly improve follow-up rates.
The monetary incentives will be provided as online gift certificates to Amazon.com. The incentives will be provided by sending the participant a code which allows the user to purchase products (books, etc.) up to the amount provided.
The two groups to be compared are:
8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.
This study's enrollment of 116 is above the median of 84 across 6,718 interventional studies indexed under Depression.
Browse Depression studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Online self-help mood management course based on cognitive behavioral therapy and social cognitive theory, plus automated online follow ups using email reminders and incentives for completing follow-ups
Behavioral: Online + incentives Follow-up Group
Intervention and automated follow ups with incentives as in the active comparator condition. The experimental procedure is adding live phone follow-ups if participant does not complete online assessment surveys at 1, 3, and 6 months in response to automated emails.
Behavioral: Online self-help course plus live follow-up if needed
In addition to the self-help mood management course and the email reminders to return to the site to complete assessments at 1, 3, and 6 months (and the monetary incentives), this condition will also receive phone reminders if they do not complete assessments online.
This group tests online email reminders and monetary online incentives to estimate percentage of participants who will complete online assessments at 1, 3, and 6 month follow-ups.
PHQ-9
Screens for symptoms of major depressive episodes (MDE).
Time frame: Baseline, 1, 3, and 6 months post consent
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco