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Healthy Mood Internet Recruitment Study (DPC-R)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01607164
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : May 25, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 28, 2012
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
Recruitment [ Time Frame: One year ]
Number of participants enrolling in the site per month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
PHQ-9 [ Time Frame: Screening, plus 1, 3, and 6 months later ]
Depression symptom measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Healthy Mood Internet Recruitment Study
Official Title  ICMJE Depression Prevention and Management Project
Brief Summary This study is pilot testing a self-help automated Website (similar to a self-help book) designed to help individuals to learn methods to manage their mood. The methods are cognitive-behavioral skills found effective in the treatment of depression when provided by live therapists. The purpose of the study is to determine the number of individuals who will visit the site, use the site, and respond to online surveys reporting their mood levels while using the site, and at 1, 3, and 6 months after starting to use the site. The investigators want to eventually examine whether learning these methods online would help prevent depression.
Detailed Description

Self-help automated website in Spanish and English consisting of an 8-lesson course on mood management based on cognitive behavioral methods.

Accessible via the web.

Follow-up assessments conducted at 1, 3, and 6 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Recruitment
Intervention  ICMJE Behavioral: Healthy Mood Project Website
Self-help automated online mood management course based on cognitive-behavioral methods to control depressed mood.
Other Name: Self-help automated Website
Study Arms  ICMJE Experimental: Online self-help mood management

Healthy Mood Project Website

Online self-help automated mood management course available in Spanish and English via a website.

Intervention consisted of 8 cognitive-behavioral mood management lessons.

Intervention: Behavioral: Healthy Mood Project Website
Publications * Muñoz RF, Beardslee WR, Leykin Y. Major depression can be prevented. Am Psychol. 2012 May-Jun;67(4):285-95. doi: 10.1037/a0027666. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
1226
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2012)
1100
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 years of age or older
  • valid email address
  • fluent in English

Exclusion Criteria:

  • less than 18 years of age
  • no valid email address
  • not fluent in English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607164
Other Study ID Numbers  ICMJE DPC-R
1R34MH091231-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Ricardo F Muñoz, Ph.D. University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP