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Feasibility of Depression Care Management by E-mail

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ClinicalTrials.gov Identifier: NCT00755235
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : June 1, 2012
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kaiser Permanente

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Depression
Intervention Other: Depression care management by secure messaging
Enrollment 208
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Secure Messaging Care Management Usual Care
Hide Arm/Group Description Participants will receive depression care management by secure messaging. Participants will receive their usual care, with no additional education or care management services.
Period Title: Overall Study
Started 106 102
Completed 104 93
Not Completed 2 9
Arm/Group Title Secure Messaging Care Management Usual Care Total
Hide Arm/Group Description Participants will receive depression care management by secure messaging. Participants will receive their usual care, with no additional education or care management services. Total of all reporting groups
Overall Number of Baseline Participants 106 102 208
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 102 participants 208 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
96
  90.6%
94
  92.2%
190
  91.3%
>=65 years
10
   9.4%
8
   7.8%
18
   8.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 102 participants 208 participants
48  (9) 48  (10) 48  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 102 participants 208 participants
Female
76
  71.7%
74
  72.5%
150
  72.1%
Male
30
  28.3%
28
  27.5%
58
  27.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 102 participants 208 participants
106 102 208
1.Primary Outcome
Title 20-Item Symptom Checklist Depression Scale
Hide Description 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.
Time Frame Measured at baseline and after 6 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants participating in outcome assessment
Arm/Group Title Secure Messaging Care Management Usual Care
Hide Arm/Group Description:
Participants will receive depression care management by secure messaging.
Participants will receive their usual care, with no additional education or care management services.
Overall Number of Participants Analyzed 104 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.95  (0.71) 1.17  (0.81)
2.Secondary Outcome
Title Treatment Satisfaction
Hide Description Single item seven point scale ranging from "very satisfied" to "very dissatisfied"
Time Frame Measured after 6 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Secure Messaging Care Management Usual Care
Hide Arm/Group Description:
Participants will receive depression care management by secure messaging.
Participants will receive their usual care, with no additional education or care management services.
Overall Number of Participants Analyzed 104 93
Measure Type: Number
Unit of Measure: participants
Very Satisfied 56 31
Less than very satisfied 48 62
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Secure Messaging Care Management Usual Care
Hide Arm/Group Description Participants will receive depression care management by secure messaging. Participants will receive their usual care, with no additional education or care management services.
All-Cause Mortality
Secure Messaging Care Management Usual Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Secure Messaging Care Management Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/93 (0.00%)    
Psychiatric disorders     
Suicide attempt   0/104 (0.00%)  0 0/93 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Secure Messaging Care Management Usual Care
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/104 (0.00%)      0/93 (0.00%)    
Findings apply only to patients who choose to communicate by online messaging.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Gregory Simon, Principal Investigator
Organization: Group Health Research Institute
Phone: 206-287-2979
Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT00755235     History of Changes
Other Study ID Numbers: R21MH082924 ( U.S. NIH Grant/Contract )
R21MH082924 ( U.S. NIH Grant/Contract )
DSIR 82-SEDR
First Submitted: September 17, 2008
First Posted: September 18, 2008
Results First Submitted: July 22, 2011
Results First Posted: June 1, 2012
Last Update Posted: November 13, 2017