Clinical trial NCT01358487: Healthy Mood Internet Intervention Research Project
Official title: Internet Intervention to Prevent Major Depressive Episodes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Keywords: Major depression
Cognitive Behavioral preventive intervention
Mood Management
Self-help
Internet
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-05-23
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is:

1. to study whether individuals WHO ARE NOT CURRENTLY SERIOUSLY DEPRESSED will participate in an online study to prevent clinical depression and
2. 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.

Detailed description: 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:

1. Email reminders + incentives
2. Email reminders + incentives + phone calls (to collect data if not done online)

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* regular (\>1 time/week) access to internet and email,
* valid email address
* fluent or almost fluent in English or Spanish \[NOTE: ENGLISH RECRUITMENT COMPLETED. SPANISH RECRUITMENT CONTINUES\]
* looking for information to help themselves, rather than another person
* must complete screening survey at the following Website: https://ihrc.ucsf.edu/Collector/Survey.ashx?Name=DPC_ScreenSurvey\&SOURCE=Prev4

Exclusion Criteria:

* less than 18 years of age
* sporadic (\<1 time/week) access to internet and email
* no valid email address
* not fluent in English or Spanish
* looking for information to help someone else
* currently suffering from serious depression and/or in treatment for depression (If you are currently depressed, consider applying for a related Internet study to manage serious depression symptoms by going to the following Website: https://ihrc.ucsf.edu/interventionConsole/Default.aspx?ConsoleName=DepressionManagementCourse)

Primary outcomes:
measure: PHQ-9
timeFrame: Baseline, 1, 3, and 6 months post consent
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: UCSF/SFGH
name: Ricardo F. Muñoz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: