Depression Management Project | NCT01150604

Studies
Depression Management Project

NCT01150604

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

Nov 15, 2018Actual

Enrollment

547Actual

Phase

Not Applicable

Conditions

Major Depression
Depression

Interventions

Self-help cognitive-behavioral online course

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

Status Module

Record Verification Date

Nov 2018

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

Jun 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jun 23, 2010

First Submission Date that Met QC Criteria

Jun 24, 2010

First Posted Date

Jun 25, 2010Estimated

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

Nov 13, 2018

Last Update Posted Date

Nov 15, 2018Actual

Name	Class
National Institute of Mental Health (NIMH)	NIH
Robert Wood Johnson Foundation	OTHER

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

The purpose of this study is to determine whether an eight-lesson self-help intervention delivered online will result in a reduction of depressive symptoms.

Detailed Description

Not provided

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

547Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Self-help course	Experimental		Behavioral: Self-help cognitive-behavioral online course

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Self-help cognitive-behavioral online course	Behavioral	A self-help online course based on cognitive behavioral therapy for major depression.	Self-help course

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quick Inventory of Depressive Symptoms - Self-report		Baseline, 1, 2, and 5 months post consent

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants will be 18 years of age or older,
Participants will have regular (>1 time/week) access to internet and email, with a valid email address,
Participants will be fluent or almost fluent in English, and
Participants will be looking for information to help themselves, rather than another person.
Only those invited to participate will be eligible.

Exclusion Criteria:

Participants under 18 years of age,
Participants will with sporadic (< 1 time/week) access to internet and email,
Participants who fail to provide an email address,
Participants with English difficulties,
Participants looking for information to help someone else, and
Participants not invited will be ineligible.

Accepts Healthy Volunteers

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
Yan Leykin, PhD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco		San Francisco	California	94143	United States

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided