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Healthy Mood Internet Intervention Research Project

Primary Purpose

Major Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Online self-help course plus live follow-up if needed
Online + incentives Follow-up Group
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Major Depression focused on measuring Major depression, Cognitive Behavioral preventive intervention, Mood Management, Self-help, Internet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Online self-help mood management course

Online self-help course plus live follow-up if needed

Arm Description

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

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.

Outcomes

Primary Outcome Measures

PHQ-9
Screens for symptoms of major depressive episodes (MDE).

Secondary Outcome Measures

Full Information

First Posted
October 12, 2010
Last Updated
November 13, 2018
Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01358487
Brief Title
Healthy Mood Internet Intervention Research Project
Official Title
Internet Intervention to Prevent Major Depressive Episodes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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: Email reminders + incentives Email reminders + incentives + phone calls (to collect data if not done online)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major depression, Cognitive Behavioral preventive intervention, Mood Management, Self-help, Internet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online self-help mood management course
Arm Type
Active Comparator
Arm Description
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
Arm Title
Online self-help course plus live follow-up if needed
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online self-help course plus live follow-up if needed
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Online + incentives Follow-up Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
PHQ-9
Description
Screens for symptoms of major depressive episodes (MDE).
Time Frame
Baseline, 1, 3, and 6 months post consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo F. Muñoz, Ph.D.
Organizational Affiliation
UCSF/SFGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Healthy Mood Internet Intervention Research Project

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