Depressive Disorder, Major, Heart Failure
Conditions
Keywords
heart failure, depressive disorder, major, cognitive therapy, self-care
Brief summary
This study evaluates stepped care for depression in patients with heart failure (HF). The stepped care intervention consists of individualized cognitive behavior therapy (CBT). Half of the participants will receive stepped care and half will receive usual care for depression; all participants will receive heart failure self-care education and support. The primary aims are to determine whether stepped care is superior to usual care for depression, and whether treating depression improves heart failure self-care outcomes.
Detailed description
Depression is associated with poor heart failure self-care. Good self-care practices, including following dietary recommendations, taking prescribed medications, monitoring symptoms, and regular light exercise have been shown to improve quality of life and survival in persons with heart failure. Both CBT and antidepressant medications have been used in previous studies to treat major depression in patients with heart failure. Participants in the intervention arm in this trial will start with CBT. Those who do not improve very much within the first 5-10 weeks of CBT may also be referred to their own physician to discuss antidepressant medications. Heart failure self-care education and support will be provided after the first 8 weeks of the depression intervention. The study will determine whether people with heart failure benefit more from self-care education and support after their depression has been treated with a stepped care intervention, as compared to usual care for depression as provided by primary care providers.
Interventions
BEHAVIORALStepped care for depression
Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure. 2. Current major depressive episode. 3. Baseline Beck Depression Inventory (BDI-II) score 14 or greater
Exclusion criteria
1. Dementia or other significant cognitive or communication deficits 2. Terminal illness other than HF 3. Insurmountable logistical barriers to participation 4. Age less than 25 years 5. Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder 6. High risk of suicide 7. Current participation in non-study psychotherapy for depression or other psychiatric conditions 8. Initiation or modification of antidepressant medication treatment within past two months 9. Renal or hepatic conditions that would preclude the use of antidepressants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory (BDI-2) Total Score | 16 weeks | The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression. |
| Self Care of Heart Failure Index (SCHFI) Maintenance Subscale | 16 weeks | The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory | 16 weeks | The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety. |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 16 weeks | The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status. |
| Hamilton Rating Scale for Depression (HAM-D-17) | 16 weeks | The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and \>17 moderate to severe depression. |
| Actigraphy | 16 weeks | Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic. |
Countries
United States
Participant flow
Recruitment details
Between February 2017 and January 2021, patients who had a clinical diagnosis of NYHA Class I-III heart failure and who received medical care at Washington University Medical Center in St. Louis were screened for study eligibility. Those who were younger than 25 years of age or who were too ill or cognitively impaired to participate were excluded. Eligible patients who provided written informed consent were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Stepped Care for Depression Participants will receive cognitive behavior therapy for depression, plus referral to their own physician for discussion of antidepressant medication if symptoms do not improve within 5-10 weeks. Participants will also receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention.
Stepped care for depression: Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated. | 69 |
| Enhanced Usual Care Participants will receive individually-tailored heart failure self-care education and support, i.e., a Tailored Self-Care (TSC) intervention. With the participant's permission, his or her personal physician will be notified about the patient's depression. The participant will be asked to discuss depression treatment options with his or her personal physician. | 70 |
| Total | 139 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Stepped Care for Depression | Enhanced Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 58.0 years STANDARD_DEVIATION 11.5 | 58.3 years STANDARD_DEVIATION 12.2 | 58.2 years STANDARD_DEVIATION 11.8 |
| Antidepressant medication | 31 Participants | 31 Participants | 62 Participants |
| Beck Anxiety Inventory (BAI) | 23.2 units on a scale STANDARD_DEVIATION 12.3 | 22.1 units on a scale STANDARD_DEVIATION 13.2 | 22.7 units on a scale STANDARD_DEVIATION 12.7 |
| Beck Depression Inventory (BDI-2) | 32.6 units on a scale STANDARD_DEVIATION 8.3 | 32.1 units on a scale STANDARD_DEVIATION 9.2 | 32.3 units on a scale STANDARD_DEVIATION 8.8 |
| Education (12 years or less) | 17 Participants | 14 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 67 Participants | 69 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hamilton Rating Scale for Depression (HAM-D-17) | 22.5 units on a scale STANDARD_DEVIATION 5.6 | 22.6 units on a scale STANDARD_DEVIATION 5.4 | 22.6 units on a scale STANDARD_DEVIATION 5.5 |
| Income ($30,000/year or less) | 35 Participants | 30 Participants | 65 Participants |
| Kansas City Cardiomyopathy Questionnaire (KCCQ) | 45.9 units on a scale STANDARD_DEVIATION 22 | 46.5 units on a scale STANDARD_DEVIATION 18.9 | 46.2 units on a scale STANDARD_DEVIATION 20.4 |
| Left ventricular ejection fraction <45% | 36 Participants | 41 Participants | 77 Participants |
| Married or partnered | 26 Participants | 27 Participants | 53 Participants |
| New York Heart Association (NYHA) class | 44 Participants | 47 Participants | 91 Participants |
| Patient Health Questionnaire (PHQ-9) | 16.9 units on a scale STANDARD_DEVIATION 4.7 | 16.2 units on a scale STANDARD_DEVIATION 5.3 | 16.5 units on a scale STANDARD_DEVIATION 5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 29 Participants | 63 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 7 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 34 Participants | 32 Participants | 66 Participants |
| Region of Enrollment United States | 69 Participants | 70 Participants | 139 Participants |
| Self-Care of Heart Failure Index: Confidence | 58.8 units on a scale STANDARD_DEVIATION 23.7 | 51.0 units on a scale STANDARD_DEVIATION 23.3 | 54.8 units on a scale STANDARD_DEVIATION 23.7 |
| Self-Care of Heart Failure Index: Maintenance | 60.7 units on a scale STANDARD_DEVIATION 15.7 | 55.5 units on a scale STANDARD_DEVIATION 16.2 | 58.1 units on a scale STANDARD_DEVIATION 16.1 |
| Self-Care of Heart Failure Index: Management | 55.7 units on a scale STANDARD_DEVIATION 22.2 | 52.4 units on a scale STANDARD_DEVIATION 22.6 | 52.4 units on a scale STANDARD_DEVIATION 22 |
| Sex: Female, Male Female | 33 Participants | 35 Participants | 68 Participants |
| Sex: Female, Male Male | 36 Participants | 35 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 69 | 1 / 70 |
| other Total, other adverse events | 0 / 69 | 0 / 70 |
| serious Total, serious adverse events | 0 / 69 | 0 / 70 |
Outcome results
Primary
Beck Depression Inventory (BDI-2) Total Score
The BDI-2 was used to assess the patient's self-reported severity of depression. Total scores can range from zero (best) to 63 (worst). Scores between 0-13 are considered to be in the nondepressed range; 14-19 are consistent with mild, 20-28 with moderate, and 29-63 with severe depression.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care for Depression | Beck Depression Inventory (BDI-2) Total Score | 15.6 score on a scale | Standard Deviation 9.7 |
| Enhanced Usual Care | Beck Depression Inventory (BDI-2) Total Score | 19.6 score on a scale | Standard Deviation 9.4 |
Primary
Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
The SCHFI Maintenance scale assesses self-reported heart failure self-care behaviors. The Maintenance score was the trial's primary self-care outcome measure. Scores range from 0 (worst) to 100 (best), with scores of 70 or higher consistent with adequate self-care.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care for Depression | Self Care of Heart Failure Index (SCHFI) Maintenance Subscale | 70.4 score on a scale | Standard Deviation 12.5 |
| Enhanced Usual Care | Self Care of Heart Failure Index (SCHFI) Maintenance Subscale | 73.0 score on a scale | Standard Deviation 11.6 |
Secondary
Actigraphy
Actigraphy was used to track the patient's physical activity level. However, actigraphy had to be discontinued during the first few months of the trial due to the COVID-19 pandemic.
Time frame: 16 weeks
Population: Although we planned to collect actigraphy data at baseline and 16 weeks and report the 16-week data as an outcome, we were unable to collect actigraphy data due to the coronavirus (COVID-19) pandemic.
Secondary
Beck Anxiety Inventory
The BAI measures the self-reported severity of anxiety symptoms. Total BAI scores range from 0 (best) to 63 (worst). A total score of 0-7 is considered nonanxious; scores between 8-15 are consistent with mild, 16-25 moderate, and 26-63 severe anxiety.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care for Depression | Beck Anxiety Inventory | 12.5 score on a scale | Standard Deviation 9.3 |
| Enhanced Usual Care | Beck Anxiety Inventory | 15.1 score on a scale | Standard Deviation 8.9 |
Secondary
Hamilton Rating Scale for Depression (HAM-D-17)
The Hamilton Rating Scale total score indicates the interviewer-rated severity of depression symptoms. Total scores can range from 0 to 52, with higher scores indicating worse depression. Patients who score 0-9 are considered to be nondepressed. Scores of 10-13 represent mild, 14-17 mild to moderate, and \>17 moderate to severe depression.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care for Depression | Hamilton Rating Scale for Depression (HAM-D-17) | 12.5 score on a scale | Standard Deviation 5.7 |
| Enhanced Usual Care | Hamilton Rating Scale for Depression (HAM-D-17) | 15.0 score on a scale | Standard Deviation 4.9 |
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ)
The KCCQ assesses the patient's self-reported, heart failure-related functioning and quality of life. Scores range from 0 (worst) to 100 (best). Scores between 0-24 are consistent with very poor to poor health status, 25-49 poor to fair health status, 50-74 fair to good health status, and 75-100 good to excellent health status.
Time frame: 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care for Depression | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 63.7 score on a scale | Standard Deviation 16.9 |
| Enhanced Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 61.2 score on a scale | Standard Deviation 57 |