Depression
Conditions
Keywords
Depression, Primary care, Effectiveness, Care management
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.
Detailed description
Symptoms of depression, such as persistent sadness, problems sleeping, and inability to feel pleasure, interfere with the daily lives of more than 20 million Americans. Previous research indicates that telephone care management systems improve the quality and outcomes of depression care, but are too expensive to be used widely. Using secure messaging over e-mail would be more cost effective than telephone care. This study will examine whether a secure messaging care management program would be feasible, based on whether participants are willing to sign up for and continue with the program, and whether the program has a positive effect on those participants enrolled in the program. Potential participants for this study will be contacted via e-mail, with a follow-up telephone call if they do not respond to the e-mail message. Only people who have used e-mails in the past year and who are starting antidepressant treatment will be contacted. The percentage of people contacted who enroll will be recorded. Participation in this study will last 6 months. Participants will be randomly assigned to receive either a secure messaging care management program, based on effective telephone management programs, or their usual care with no intervention. Those receiving the secure messaging program will receive an initial welcome message and monitoring messages approximately 2, 6, and 10 weeks after treatment has begun. The monitoring messages will include structured assessments of depression severity, medication adherence, medication side effects, and barriers to continuing treatment. Participants who do not respond to monitoring messages will receive up to two e-mailed reminders. Care managers will analyze the results of monitoring messages, provide feedback and recommendations to physicians, coordinate physician follow-ups, and facilitate emergency care or specialty referrals. Care managers will also provide patients with motivation, based on semi-scripted protocols, and education concerning their disorder and treatment. Measures of the success of the study will be taken at enrollment and after 6 months of participation. Specific measurements will include the response rate of recruitment e-mails, response rate for follow-up data collection, proportion of those in the secure messaging program who complete the monitoring assessments, effects of the program on antidepressant treatment, and effects of the program on patient satisfaction.
Interventions
OTHERDepression care management by secure messaging
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.
Sponsors
National Institute of Mental Health (NIMH)
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 20-Item Symptom Checklist Depression Scale | Measured at baseline and after 6 months of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Satisfaction | Measured after 6 months of treatment | Single item seven point scale ranging from very satisfied to very dissatisfied |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Secure Messaging Care Management Participants will receive depression care management by secure messaging. | 106 |
| Usual Care Participants will receive their usual care, with no additional education or care management services. | 102 |
| Total | 208 |
Baseline characteristics
| Characteristic | Usual Care | Secure Messaging Care Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants | 96 Participants | 190 Participants |
| Age, Continuous | 48 years STANDARD_DEVIATION 10 | 48 years STANDARD_DEVIATION 9 | 48 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 102 participants | 106 participants | 208 participants |
| Sex: Female, Male Female | 74 Participants | 76 Participants | 150 Participants |
| Sex: Female, Male Male | 28 Participants | 30 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 104 | 0 / 93 |
| serious Total, serious adverse events | 0 / 104 | 0 / 93 |
Outcome results
Primary
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.
Time frame: Measured at baseline and after 6 months of treatment
Population: Analysis included all participants participating in outcome assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Secure Messaging Care Management | 20-Item Symptom Checklist Depression Scale | 0.95 units on a scale | Standard Deviation 0.71 |
| Usual Care | 20-Item Symptom Checklist Depression Scale | 1.17 units on a scale | Standard Deviation 0.81 |
Secondary
Treatment Satisfaction
Single item seven point scale ranging from very satisfied to very dissatisfied
Time frame: Measured after 6 months of treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Secure Messaging Care Management | Treatment Satisfaction | Very Satisfied | 56 participants |
| Secure Messaging Care Management | Treatment Satisfaction | Less than very satisfied | 48 participants |
| Usual Care | Treatment Satisfaction | Very Satisfied | 31 participants |
| Usual Care | Treatment Satisfaction | Less than very satisfied | 62 participants |