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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
139
Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
Behavioral Medicine Center Washington University
St Louis, Missouri, United States
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
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
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
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
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.
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Time frame: 16 weeks
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