Depression, Generalized Anxiety Disorder, Panic Disorder
Conditions
Keywords
Collaborative care, Cardiovascular disease, Depression, Anxiety
Brief summary
For this trial, the investigators propose a prospective trial of a collaborative care program to identify and treat depression, generalized anxiety disorder, and panic disorder among patients admitted to the hospital for an acute cardiac illness (acute coronary syndrome, congestive heart failure, or arrhythmia). Such assessment and treatment for depression/generalized anxiety disorder/panic disorder will begin in the hospital, and ongoing management will continue for six months following discharge. The investigators hypothesize that this model will lead to increased treatment rates, improved mood, reduced anxiety, and improved medical outcomes in this vulnerable population. If this model is effective, it could be implemented clinically to provide better and more complete care to patients hospitalized with acute cardiac illness, for whom depression and anxiety may be a risk factor for complications and death. This will be a two-arm, single-blind randomized controlled trial, with one-half of patients randomized to collaborative care and one-half randomized to the control condition (usual care). Psychiatric treatment in the intervention arm will be provided in concert with patients' primary care physicians-with primary care physicians prescribing all medications-within a framework supervised by a psychiatrist. The investigators will enroll patients who have any (or all) of the three included psychiatric diagnoses to improve the utility of the intervention. The investigators have chosen to enroll patients with several different cardiac diagnoses. This will allow the researchers to include patients with heterogeneous diagnoses and illness severity to determine if our intervention is effective in a broad population of patients with heart disease. The investigators will study an intervention targeting depression, generalized anxiety disorder, and panic disorder: all three disorders are disabling and associated with adverse cardiovascular outcomes, treatments for the conditions are highly similar, the investigators can treat patients who have more than one disorder, and a prior outpatient program successfully simultaneously addressed more than one mental health condition. The project will involve: (1) screening patients for depression, generalized anxiety disorder, and panic disorder as part of usual clinical care, (2) evaluation of positive-screen patients by a study social work care manager, (3) a multicomponent in-hospital intervention (for collaborative care patients) that involves patient education, specialist-provided treatment recommendations, and a goal of in-hospital treatment initiation, and (4), after discharge, continued phone-based evaluation and care coordination with primary care physicians to provide stepwise treatment in the collaborative care arm. The intervention has been designed to be low-cost, low-burden, and easily generalizable to other settings.
Detailed description
* Primary in-hospital outcome measure: \- Adequate treatment by discharge (percent rates) * Primary overall study measure: \- Change from baseline mental health-related quality of life (Short Form-12 Mental Component Score) * Depression outcome measures: \- Change from baseline depression (Patient Health Questionnaire-9) * Anxiety outcome measures: \- Change from baseline anxiety (Hospital Anxiety and Depression Scale-Anxiety Subscale) * Medical outcome measures: * Change from baseline physical function (Duke Activity Status Index) * Change from baseline adherence (Medical Outcomes Study Specific Adherence Scale) * Change from baseline physical health-related quality of life (Short Form-12 Physical Component Score) * Change in rates of cardiac rehospitalizations at 24 weeks (exploratory aim) * 24 weeks is primary endpoint for all post-discharge analyses \*
Interventions
OTHERCollaborative care
Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.
OTHERUsual care
Patient's primary medical physician informed of mental health symptoms/diagnosis
Sponsors
American Heart Association
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (age 18-up)admitted to inpatient cardiac unit at Massachusetts General Hospital * Primary diagnosis of acute coronary syndrome, congestive heart failure, or arrhythmia * Positive anxiety or depression screen during initial nursing intake interview that is performed as part of usual clinical care * Meets criteria for clinical depression, generalized anxiety disorder, or panic disorder
Exclusion criteria
* Bipolar disorder * Substance use disorder * Psychosis * Cognitive disorder * Active suicidal ideation * Medical condition with likely survival less than 6 months * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mental Health-related Quality of Life From Baseline to 24 Weeks | Baseline, 24 weeks | Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Symptoms From Baseline to 24 Weeks | Baseline, 24 weeks | Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety. |
| Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment | 5 days after enrollment | Adequate treatment was defined as: (1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study). Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as: (1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm). Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects. |
| Change in Adherence to Health Behaviors From Baseline to 24 Weeks | Baseline, 24 weeks | Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors. |
| Change in Depression Symptoms From Baseline to 24 Weeks | Baseline, 24 weeks | Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed. |
| Change in Health Status From Baseline to 24 Weeks | Baseline, 24 weeks | Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life. |
| Change in Physical Function From Baseline to 24 Weeks | Baseline, 24 weeks | Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function. |
| Change in Physical Health-related Quality of Life From Baseline to 24 Weeks | Baseline, 24 weeks | Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life. |
| Number of Rehospitalizations From Baseline to 24 Weeks | 24 weeks | The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collaborative Care Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.
Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians. | 92 |
| Usual Care Patient's physicians are informed of diagnosis of depression/anxiety disorder
Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis | 91 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 5 |
Baseline characteristics
| Characteristic | Usual Care | Total | Collaborative Care |
|---|---|---|---|
| Age, Continuous | 60.1 years STANDARD_DEVIATION 12.8 | 60.5 years STANDARD_DEVIATION 12.7 | 60.9 years STANDARD_DEVIATION 12.7 |
| Duke Activity Status Index | 21.4 units on a scale STANDARD_DEVIATION 16.9 | 20.5 units on a scale STANDARD_DEVIATION 16.3 | 19.7 units on a scale STANDARD_DEVIATION 15.8 |
| Euro Quality of Life-5 Domain | 0.44 units on a scale STANDARD_DEVIATION 0.33 | 0.42 units on a scale STANDARD_DEVIATION 0.34 | 0.40 units on a scale STANDARD_DEVIATION 0.34 |
| Hospital Anxiety and Depression Scale - Anxiety Subscale | 11.5 units on a scale STANDARD_DEVIATION 3.9 | 11.2 units on a scale STANDARD_DEVIATION 3.9 | 10.9 units on a scale STANDARD_DEVIATION 4 |
| Medical Outcomes Study - Specific Adherence Scale | 14.2 units on a scale STANDARD_DEVIATION 3.1 | 13.6 units on a scale STANDARD_DEVIATION 3.3 | 13.0 units on a scale STANDARD_DEVIATION 3.5 |
| Patient Health Questionnaire-9 | 15.6 units on a scale STANDARD_DEVIATION 5 | 15.8 units on a scale STANDARD_DEVIATION 4.6 | 15.9 units on a scale STANDARD_DEVIATION 4.2 |
| Region of Enrollment United States | 91 participants | 183 participants | 92 participants |
| Sex: Female, Male Female | 43 Participants | 86 Participants | 43 Participants |
| Sex: Female, Male Male | 48 Participants | 97 Participants | 49 Participants |
| SF-12 Mental Component Score | 36.3 units on a scale STANDARD_DEVIATION 8.9 | 35.2 units on a scale STANDARD_DEVIATION 9.3 | 34.2 units on a scale STANDARD_DEVIATION 9.7 |
| SF-12 Physical Component Score | 33.8 units on a scale STANDARD_DEVIATION 11 | 32.9 units on a scale STANDARD_DEVIATION 10.5 | 32.9 units on a scale STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 92 | 0 / 91 |
| serious Total, serious adverse events | 0 / 92 | 0 / 91 |
Outcome results
Primary
Change in Mental Health-related Quality of Life From Baseline to 24 Weeks
Mental health-related quality of life is measured by the Short Form-12 Mental Component Score (SF-12 MCS). The SF-12 MCS is a 6-item scale that assesses mental health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average mental health-related quality of life. Higher scores represent higher than average mental health-related quality of life, and lower scores represent lower mental health-related quality of life.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Mental Health-related Quality of Life From Baseline to 24 Weeks | 8.87 units on a scale |
| Usual Care | Change in Mental Health-related Quality of Life From Baseline to 24 Weeks | 8.39 units on a scale |
p-value: 0.00295% CI: [2.14, 9.22]Mixed Models Analysis
Secondary
Change in Adherence to Health Behaviors From Baseline to 24 Weeks
Adherence to health behaviors is measured with the Medical Outcome Study Specific Adherence Scale (MOS-SAS). The MOS-SAS is a 3-item scale used to assess medication adherence, physical activity adherence, and diet adherence. Each question asks how often the subject adheres to the behavior, providing the following options: 1 = None of the time, 2 = A little of the time, 3 = Some of the time, 4 = A good bit of the time, 5 = Most of the time, 6 = All of the time. Scores are totaled and range from (3 to 18). A low score indicates poorer adherence to healthy behaviors.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Adherence to Health Behaviors From Baseline to 24 Weeks | 2.2 units on a scale |
| Usual Care | Change in Adherence to Health Behaviors From Baseline to 24 Weeks | 1.70 units on a scale |
p-value: 0.2895% CI: [-0.51, 1.76]Mixed Models Analysis
Secondary
Change in Anxiety Symptoms From Baseline to 24 Weeks
Anxiety symptoms measured with the Hospital Anxiety and Depression Scale - Anxiety Subscale (HADS-A). The HADS-A is a 7-item scale used to measure anxiety severity. Each question asks about a specific symptom of anxiety and offers four answers: 0 = Never / Not at all, 1 = A little / Time to time, 2 = Quite often / Usually, 3 = Most of the time / Very often. Scores are totaled and range from 0-21. A higher score means more anxiety.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Anxiety Symptoms From Baseline to 24 Weeks | -3.43 units on a scale |
| Usual Care | Change in Anxiety Symptoms From Baseline to 24 Weeks | -4.85 units on a scale |
p-value: 0.5595% CI: [-0.93, 1.76]Mixed Models Analysis
Secondary
Change in Depression Symptoms From Baseline to 24 Weeks
Depression symptoms measured by the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item scale that measures depression severity. Each question asks how often the subject experiences symptoms of depression and offers four answers: 0 = Not at all, 1 = Several days, 2 = More than half the days, 3 = Nearly every day. Scores are totaled and range from 0-27. To be considered depressed, subjects had to (a) have a total score of 10 or more, (b) answer five questions with a score of 2 or 3, and (c) one of the five questions had to be question 1 or question 2 (or both). Anyone who did not meet these criteria were not considered depressed.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Depression Symptoms From Baseline to 24 Weeks | -6.99 units on a scale |
| Usual Care | Change in Depression Symptoms From Baseline to 24 Weeks | -7.67 units on a scale |
p-value: 0.04595% CI: [-4.06, -0.05]Mixed Models Analysis
Secondary
Change in Health Status From Baseline to 24 Weeks
Health status measured by the Euro Quality of Life-5 Domain (EQ5D). The EQ5D is a 5-item scale that assesses quality of life. Each question asks about difficulties with certain areas of health (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and offer three possible answers: No problems, Moderate problems, Extreme problems. Scores can range from 0.000-1.000, with lower scores indicating less quality of life, and higher scores indicating higher quality of life.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Health Status From Baseline to 24 Weeks | 0.16 units on a scale |
| Usual Care | Change in Health Status From Baseline to 24 Weeks | 0.18 units on a scale |
p-value: 0.02995% CI: [0.012, 0.22]Mixed Models Analysis
Secondary
Change in Physical Function From Baseline to 24 Weeks
Physical function is measured with the Duke Activity Status Index (DASI). The DASI is a 12-item scale that measures physical function. Each question asks about whether the subject can complete a physical activity and are given the following options: Scores range from 0 to 58.2. Lower scores indicate lower levels of physical function.
Time frame: Baseline, 24 weeks
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Physical Function From Baseline to 24 Weeks | 8.96 units on a scale |
| Usual Care | Change in Physical Function From Baseline to 24 Weeks | 9.52 units on a scale |
p-value: 0.00595% CI: [1.71, 9.46]Mixed Models Analysis
Secondary
Change in Physical Health-related Quality of Life From Baseline to 24 Weeks
Physical health-related quality of life is measured with the Short Form-12 Physical Component Score (SF-12 PCS). The SF-12 PCS a 6-item scale that assesses physical health-related quality of life. Each question provides the option of 2-6 answers. Some questions are Yes/No (2 options), while others ask how often something occurs (6 options, etc.). Scores are calculated using a formula and can range from 0 to 100. A score of 50 indicates average physical health-related quality of life. Higher scores represent higher than average physical health-related quality of life, and lower scores represent lower physical health-related quality of life.
Time frame: Baseline, 24 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Collaborative Care | Change in Physical Health-related Quality of Life From Baseline to 24 Weeks | 2.75 units on a scale |
| Usual Care | Change in Physical Health-related Quality of Life From Baseline to 24 Weeks | 4.21 units on a scale |
p-value: 0.1195% CI: [-0.54, 5.14]Mixed Models Analysis
Secondary
Number of Rehospitalizations From Baseline to 24 Weeks
The number of rehospitalizations from baseline to 24 weeks was measured by contacting subjects' medical providers at 24 weeks and by asking subjects about rehospitalizations during each follow-up phone call.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Care | Number of Rehospitalizations From Baseline to 24 Weeks | 29 readmissions |
| Usual Care | Number of Rehospitalizations From Baseline to 24 Weeks | 30 readmissions |
p-value: 0.8395% CI: [0.63, 1.46]Chi-squared
Secondary
Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment
Adequate treatment was defined as: (1) Prescription of a standard dose of an established first-line treatment for depression, generalized anxiety disorder, or panic disorder, and/or (2) referral to evidence-based psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborative Care arm of the study). Patients already engaged in #1 and/or #2 at the time of enrollment had a different process. Subjects must have been engaged in at least 4 weeks of treatment prior to enrollment while still meeting criteria for the disorder. For this population, adequate treatment was defined as: (1) Prescription dose increase/augmentation/switch, and/or (2) referral to psychotherapy (either to an outside mental health provider or a Cognitive Behavioral Therapy workbook in the Collaborate Care arm). Timeframe of 5 days after enrollment was determined by calculating the median length of hospitalization for all subjects.
Time frame: 5 days after enrollment
Population: 92 participants in the Collaborative Care group were compared to 91 participants in the Usual Care group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Care | Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment | 69 participants |
| Usual Care | Rate of Adequate Treatment of Depression and/or Anxiety Symptoms 5 Days After Enrollment | 6 participants |
p-value: <0.00195% CI: [5.2, 24.9]Chi-squared