Trial Outcomes & Findings for Feasibility of Depression Care Management by E-mail (NCT NCT00755235)

NCT ID: NCT00755235

Last Updated: 2017-11-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 208 participants
• Primary outcome timeframe: Measured at baseline and after 6 months of treatment
• Results posted on: 2017-11-13

Participant Flow

Participant milestones

Measure	Secure Messaging Care Management Participants will receive depression care management by secure messaging.	Usual Care Participants will receive their usual care, with no additional education or care management services.
Overall Study STARTED	106	102
Overall Study COMPLETED	104	93
Overall Study NOT COMPLETED	2	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility of Depression Care Management by E-mail

Baseline characteristics by cohort

Measure	Secure Messaging Care Management n=106 Participants Participants will receive depression care management by secure messaging.	Usual Care n=102 Participants Participants will receive their usual care, with no additional education or care management services.	Total n=208 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=5 Participants	94 Participants n=7 Participants	190 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 9 • n=5 Participants	48 years STANDARD_DEVIATION 10 • n=7 Participants	48 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants	74 Participants n=7 Participants	150 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Region of Enrollment United States	106 participants n=5 Participants	102 participants n=7 Participants	208 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and after 6 months of treatment

Population: Analysis included all participants participating in outcome assessment

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.

Outcome measures

Measure	Secure Messaging Care Management n=104 Participants Participants will receive depression care management by secure messaging.	Usual Care n=93 Participants Participants will receive their usual care, with no additional education or care management services.
20-Item Symptom Checklist Depression Scale	0.95 units on a scale Standard Deviation 0.71	1.17 units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Measured after 6 months of treatment

Single item seven point scale ranging from "very satisfied" to "very dissatisfied"

Outcome measures

Measure	Secure Messaging Care Management n=104 Participants Participants will receive depression care management by secure messaging.	Usual Care n=93 Participants Participants will receive their usual care, with no additional education or care management services.
Treatment Satisfaction Very Satisfied	56 participants	31 participants
Treatment Satisfaction Less than very satisfied	48 participants	62 participants

Adverse Events

Secure Messaging Care Management

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Secure Messaging Care Management n=104 participants at risk Participants will receive depression care management by secure messaging.	Usual Care n=93 participants at risk Participants will receive their usual care, with no additional education or care management services.
Psychiatric disorders Suicide attempt	0.00% 0/104	0.00% 0/93

Other adverse events

Adverse event data not reported

Additional Information

Gregory Simon, Principal Investigator

Group Health Research Institute

Phone: 206-287-2979

Email: simon.g@ghc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place