NCT01358487

Brief Summary

The purpose of the study is:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

1.5 years

First QC Date

October 12, 2010

Last Update Submit

November 13, 2018

Conditions

Major Depression

Keywords

Major depressionCognitive Behavioral preventive interventionMood ManagementSelf-helpInternet

Outcome Measures

Primary Outcomes (1)

  • PHQ-9

    Screens for symptoms of major depressive episodes (MDE).

    Baseline, 1, 3, and 6 months post consent

Study Arms (2)

Online self-help mood management course

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

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

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.

Online self-help course plus live follow-up if needed
Online + incentives Follow-up GroupBEHAVIORAL

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.

Online self-help mood management course

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Ricardo F. Muñoz, Ph.D.

    UCSF/SFGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2010

First Posted

May 23, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

November 15, 2018

Record last verified: 2018-11

Locations

US(1)