Depression
Conditions
Keywords
Depression, Patient Participation, Text messaging, Patient Portals
Brief summary
Patients and providers need effective tools to help promote adherence to newly prescribed medications for depression and to determine if this medication is improving depressed mood. This study will test an intervention that uses 1) VA's text messaging program called Annie to help patient's engage in self-management when starting a new medication for depression and 2) My HealtheVet, VA's patient portal, for education and communication with their VA health care team. The goals of this intervention are to improve adherence to depression medication and depressive symptoms in Veterans.
Detailed description
Background: There are several known challenges to starting a medication for depression, such as side effects and needing four to six weeks before the effects of the medication may be noticed. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve antidepressant adherence and depression outcomes in Veterans initiating medication to treat depression by using Annie, VA's short messaging services (SMS) application and My HealtheVet, VA's patient portal. Method: Veterans will be eligible if they are initiating a new antidepressant medication as part of their care at the Iowa City VA primary care or mental health. Veterans will be randomized to one of three groups, usual care or 1 of 2 interventional groups (Annie or Annie plus). Veterans in the intervention groups will 1) receive education about depression and the importance of taking medications as prescribed and 2) receive text messages from Annie with information and questions for response. For example, are Veterans taking their medication, is their medication working, and how would they rate their mood. They will also receive weekly reports about their responses to Annie through My HealtheVet, VA's patient portal. In addition, Veterans assigned to Annie Plus will receive a weekly phone call to review progress and to answer any questions. Prior to a participant's scheduled follow-up appointment, a summary of information collected to date via Annie will be made available to the clinical team in the medical record. At the end of the study, participants will be invited to complete a recorded interview about their experiences using the Annie text messaging program and to provide any recommendations for changes. VA providers will also be invited to complete a recorded phone interview about their experience with patients using Annie. For Veterans randomized to the control condition, research staff will provide education about depression and the importance of taking medications as prescribed. Staff will contact participants in this arm by phone just prior to scheduled follow up visits to discuss any concerns the patient may be experiencing. A sample of Veterans will be asked to complete a recorded interview about their medication management at the end of the study.
Interventions
BEHAVIORALAIMS
Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
BEHAVIORALAIMS plus
Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
This study will test an intervention designed to improve antidepressant adherence and depression outcomes in Veterans initiating or changing antidepressant medication to treat depression. Veterans will be assigned to 1) use Annie, VA's short message service (SMS) in combination with My HealtheVet, VA's online patient portal, 2) use Annie plus receive a weekly phone call, or 3) to the control group who will not be enrolled in Annie.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
VA Patient * Diagnosed with depression * Initiating or changing to a new antidepressant medication * Cell phone with text messaging capabilities * Registered with My HealtheVet * Follow-up appointment with their provider in the next 12 weeks * Internet access * English speaking VA Providers: provide care to a study participant
Exclusion criteria
* Lack of cell phone access/willingness to receive text messages * Diagnosis of cognitive disorders, psychotic disorders, bipolar disorder, or active substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence at Baseline, 6 Weeks and 12 Weeks | Baseline, 6 and 12 weeks | Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | Baseline, 6 and 12 weeks | Patient Health Questionnaire (PHQ-9) - a standard instrument for measuring depressive symptom severity and monitoring treatment outcomes over time. A score of 4 or less indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 indicates severe depression. The total score may range from 0 -27. |
| Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | Baseline, 6 and 12 weeks | The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER): The 3-item FIBSER asks about the frequency, severity, and functional impact of antidepressant side effects using a 0 to 6- Likert scale. The prevalence and distribution of scores for each domain will be compared across assessment time points. Higher scores indicate greater side effect burden while lower scores indicate lesser. The range for the total score on the measure can span from 0 to 18. A decline in total score is the desired outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AIMS Intervention Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol.
AIMS: Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame. | 17 |
| No Intervention Participants randomized to the no intervention arm will not be enrolled in the Annie text messaging program. | 18 |
| AIMS Intervention Plus Participants randomized to the AIMS Intervention Plus arm will be enrolled in VA's Annie text messaging program/study protocol and receive a weekly phone call.
AIMS plus: Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame. | 18 |
| Total | 53 |
Baseline characteristics
| Characteristic | AIMS Intervention | Total | AIMS Intervention Plus | No Intervention |
|---|---|---|---|---|
| Age, Continuous | 40.11 years STANDARD_DEVIATION 10.65 | 45.72 years STANDARD_DEVIATION 13.21 | 47.5 years STANDARD_DEVIATION 14.26 | 49.55 years STANDARD_DEVIATION 14.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 48 Participants | 16 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 17 Participants | 51 Participants | 17 Participants | 17 Participants |
| Region of Enrollment United States | 17 Participants | 53 Participants | 18 Participants | 18 Participants |
| Sex: Female, Male Female | 4 Participants | 15 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 13 Participants | 38 Participants | 14 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 17 | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 18 | 0 / 18 |
Outcome results
Primary
Medication Adherence at Baseline, 6 Weeks and 12 Weeks
Medication Adherence Rating Scale - 10 item self-report measure of medication taking attitudes, behaviors, and side effects. It is scored on a 0-10 scale with higher scores indicating greater adherence.
Time frame: Baseline, 6 and 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AIMS Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 2.66 score on a scale | Standard Error 0.48 |
| AIMS Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | Baseline | 3.41 score on a scale | Standard Error 0.46 |
| AIMS Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 2.58 score on a scale | Standard Error 0.48 |
| No Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 1.44 score on a scale | Standard Error 0.45 |
| No Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | Baseline | 1.32 score on a scale | Standard Error 0.45 |
| No Intervention | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 1.56 score on a scale | Standard Error 0.45 |
| AIMS Intervention Plus | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | Baseline | 2.55 score on a scale | Standard Error 0.45 |
| AIMS Intervention Plus | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 2.57 score on a scale | Standard Error 0.48 |
| AIMS Intervention Plus | Medication Adherence at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 2.16 score on a scale | Standard Error 0.47 |
p-value: 0.1Mixed Models Analysis
Secondary
Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks
Patient Health Questionnaire (PHQ-9) - a standard instrument for measuring depressive symptom severity and monitoring treatment outcomes over time. A score of 4 or less indicates minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression, and 20-27 indicates severe depression. The total score may range from 0 -27.
Time frame: Baseline, 6 and 12 weeks
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AIMS Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 12.20 units on a scale | Standard Error 1.58 |
| AIMS Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 13.34 units on a scale | Standard Error 1.55 |
| AIMS Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | Baseline | 15.41 units on a scale | Standard Error 1.43 |
| No Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 11.45 units on a scale | Standard Error 1.4 |
| No Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | Baseline | 13.27 units on a scale | Standard Error 1.38 |
| No Intervention | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 11.38 units on a scale | Standard Error 1.38 |
| AIMS Intervention Plus | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 6-Weeks | 9.29 units on a scale | Standard Error 1.5 |
| AIMS Intervention Plus | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | Baseline | 12.00 units on a scale | Standard Error 1.38 |
| AIMS Intervention Plus | Depressive Symptoms at Baseline, 6 Weeks and 12 Weeks | 12-Weeks | 8.70 units on a scale | Standard Error 1.56 |
p-value: 0.9Mixed Models Analysis
Secondary
Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks
The Frequency, Intensity, and Burden of Side Effects Ratings (FIBSER): The 3-item FIBSER asks about the frequency, severity, and functional impact of antidepressant side effects using a 0 to 6- Likert scale. The prevalence and distribution of scores for each domain will be compared across assessment time points. Higher scores indicate greater side effect burden while lower scores indicate lesser. The range for the total score on the measure can span from 0 to 18. A decline in total score is the desired outcome.
Time frame: Baseline, 6 and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AIMS Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 6-Weeks | 3.83 units on a scale | Standard Error 1.11 |
| AIMS Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | Baseline | 6.05 units on a scale | Standard Error 1 |
| AIMS Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 12-Weeks | 4.06 units on a scale | Standard Error 1.11 |
| No Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 6-Weeks | 4.88 units on a scale | Standard Error 0.97 |
| No Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | Baseline | 3.38 units on a scale | Standard Error 0.97 |
| No Intervention | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 12-Weeks | 3.73 units on a scale | Standard Error 1.01 |
| AIMS Intervention Plus | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | Baseline | 3.55 units on a scale | Standard Error 0.97 |
| AIMS Intervention Plus | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 12-Weeks | 2.53 units on a scale | Standard Error 1.14 |
| AIMS Intervention Plus | Medication Side Effects at Baseline, 6 Weeks, and 12 Weeks | 6-Weeks | 1.51 units on a scale | Standard Error 1.07 |
p-value: 0.08Mixed Models Analysis