Healthy Mood Internet Intervention Research Project
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|ClinicalTrials.gov Identifier: NCT01358487|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : March 13, 2013
The purpose of the study is:
- to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate in an online study to prevent clinical depression and
- to estimate the percentage of participants who will complete online assessments at 1, 3, and 6 months when receiving either a) email reminders + monetary online incentives or b) email reminders + monetary incentives + phone calls.
NOTE: RECRUITMENT IS COMPLETED.
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Behavioral: Online self-help course plus live follow-up if needed Behavioral: Online + incentives Follow-up Group||Phase 1|
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:
- Email reminders + incentives
- Email reminders + incentives + phone calls (to collect data if not done online)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Internet Intervention to Prevent Major Depressive Episodes|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: Online self-help mood management course
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
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.
Experimental: Online self-help course plus live follow-up if needed
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.
- PHQ-9 [ Time Frame: Baseline, 1, 3, and 6 months post consent ]Screens for symptoms of major depressive episodes (MDE).
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): NCT01358487
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Ricardo F. Muñoz, Ph.D.||UCSF/SFGH|