Depression
Conditions
Keywords
Depression, Depressive disorder, Decision Making, Decision Aids, Decision Quality Instrument
Brief summary
The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.
Interventions
BEHAVIORALDVD/Booklet: Coping with Symptoms of Depression
DVD and booklet that provides information about treatment choices for depression symptoms
Sponsors
Foundation for Informed Medical Decision Making
Massachusetts General Hospital
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18+ * In the last 12 months, talked to a health care provider about starting or stopping a treatment (prescription medicine for depression or counseling)
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression Knowledge | 2 weeks, on average | Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Value Concordance | 2 weeks, on average | Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs |
Countries
United States
Participant flow
Recruitment details
Patients were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C. August 5, 2010-Jan 10, 2011.
Pre-assignment details
Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Group receiving the decision aid (DVD/booklet) | 191 |
| Control Group not receiving the decision aid (DVD/booklet) | 214 |
| Total | 405 |
Baseline characteristics
| Characteristic | Control | Decision Aid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 209 Participants | 186 Participants | 395 Participants |
| Age Continuous | 43.5 years STANDARD_DEVIATION 16.8 | 39.5 years STANDARD_DEVIATION 13.4 | 42 years STANDARD_DEVIATION 15.4 |
| Region of Enrollment United States | 214 participants | 191 participants | 405 participants |
| Sex: Female, Male Female | 144 Participants | 122 Participants | 266 Participants |
| Sex: Female, Male Male | 70 Participants | 69 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 191 | 0 / 214 |
| serious Total, serious adverse events | 0 / 191 | 0 / 214 |
Outcome results
Primary
Depression Knowledge
Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%).
Time frame: 2 weeks, on average
Population: Participants were randomized to receive the DVD and booklet.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid | Depression Knowledge | 67.0 percent of correct responses | Standard Deviation 14.1 |
| Control | Depression Knowledge | 63.6 percent of correct responses | Standard Deviation 12.5 |
Comparison: We tested for a difference in the mean total knowledge score between the decision aid and control groups using independent t-test (2 sided). With 100 patients in each arm, the study had more than 90% power to detect a 10% difference in knowledge assuming a common standard deviation of 18%.p-value: 0.0195% CI: [0.76, 6.09]t-test, 2 sided
Secondary
Value Concordance
Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs
Time frame: 2 weeks, on average