NCT00755235

Brief Summary

This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable depression

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

September 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 18, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

June 1, 2012

Completed
Last Updated

November 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1 year

First QC Date

September 17, 2008

Results QC Date

July 22, 2011

Last Update Submit

October 11, 2017

Conditions

Depression

Keywords

DepressionPrimary careEffectivenessCare management

Outcome Measures

Primary Outcomes (1)

  • 20-Item Symptom Checklist Depression Scale

    20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.

    Measured at baseline and after 6 months of treatment

Secondary Outcomes (1)

  • Treatment Satisfaction

    Measured after 6 months of treatment

Study Arms (2)

1

EXPERIMENTAL

Participants will receive depression care management by secure messaging.

Other: Depression care management by secure messaging

2

NO INTERVENTION

Participants will receive their usual care, with no additional education or care management services.

Interventions

Depression care management by secure messagingOTHER

Participants will receive electronic messages welcoming them and monitoring their antidepressant treatment. Care managers will use monitoring data to aid participants' physicians, coordinate physician follow-ups, facilitate emergency care, and facilitate specialty referrals. Care managers will also provide motivation and education to participants.

Also known as: online messaging, email
1

Eligibility Criteria

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

You may qualify if:

  • Patient at Capitol Hill or Rainier clinics of Group Health Cooperative in Seattle
  • New prescription of an antidepressant, defined by an interval of at least 180 days since a previous antidepressant prescription
  • Indication of depression, defined by a visit diagnosis of major depressive disorder (Internal Classification of Diseases 9th Revision \[ICD9\] codes 296.2x or 296.3x) within 30 days of the first prescription
  • Has used secure messaging, or e-mailing, at least twice in the last 12 months

You may not qualify if:

  • Any diagnosis of psychotic disorder or bipolar disorder in the prior 2 years
  • Any prescription for mood stabilizer or antipsychotic medication in the prior 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Group Health Cooperative Center for Health Studies

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • Simon GE, Ralston JD, Savarino J, Pabiniak C, Wentzel C, Operskalski BH. Randomized trial of depression follow-up care by online messaging. J Gen Intern Med. 2011 Jul;26(7):698-704. doi: 10.1007/s11606-011-1679-8. Epub 2011 Mar 8.

    PMID: 21384219RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and Caveats

Findings apply only to patients who choose to communicate by online messaging.

Results Point of Contact

Title
Gregory Simon, Principal Investigator
Organization
Group Health Research Institute
simon.g@ghc.org
206-287-2979

Study Officials

  • Gregory E. Simon, MD, MPH

    Group Health Cooperative Center for Health Studies

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2008

First Posted

September 18, 2008

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

November 13, 2017

Results First Posted

June 1, 2012

Record last verified: 2017-10

Locations

US(1)