Healthy Mood Internet Intervention Research Project

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01358487
First received: October 12, 2010
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Major Depression
Behavioral: Online self-help course plus live follow-up if needed
Behavioral: Online + incentives Follow-up Group
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Internet Intervention to Prevent Major Depressive Episodes

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • PHQ-9 [ Time Frame: Baseline, 1, 3, and 6 months post consent ] [ Designated as safety issue: No ]
    Screens for symptoms of major depressive episodes (MDE).


Enrollment: 116
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358487

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Ricardo F. Muñoz, Ph.D. UCSF/SFGH
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01358487     History of Changes
Other Study ID Numbers: CHR10-00059, 1R34MH091231-01
Study First Received: October 12, 2010
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Major depression
Cognitive Behavioral preventive intervention
Mood Management
Self-help
Internet

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014