Healthy Mood Internet Recruitment Study | NCT01607164

Studies
Healthy Mood Internet Recruitment Study

NCT01607164

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

May 25, 2015Estimated

Enrollment

1,226Actual

Phase

Not Applicable

Conditions

Recruitment

Interventions

Healthy Mood Project Website

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R34MH091231-01	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2012

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

May 24, 2012

First Submission Date that Met QC Criteria

May 25, 2012

First Posted Date

May 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2015

Last Update Posted Date

May 25, 2015Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,226Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Online self-help mood management	Experimental	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.	Behavioral: Healthy Mood Project Website

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Healthy Mood Project Website	Behavioral	Self-help automated online mood management course based on cognitive-behavioral methods to control depressed mood.	Online self-help mood management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recruitment	Number of participants enrolling in the site per month	One year

Secondary Outcomes

Measure	Description	Time Frame
PHQ-9	Depression symptom measure	Screening, plus 1, 3, and 6 months later

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo F Muñoz, Ph.D.	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UCSF Psychiatry at San Francisco General Hospital		San Francisco	California	94110	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22583342	Background	Munoz RF, Beardslee WR, Leykin Y. Major depression can be prevented. Am Psychol. 2012 May-Jun;67(4):285-95. doi: 10.1037/a0027666.

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior