Trial Outcomes & Findings for Stepped Care for Depression in Heart Failure (NCT NCT02997865)
NCT ID: NCT02997865
Last Updated: 2023-02-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
139 participants
Primary outcome timeframe
16 weeks
Results posted on
2023-02-10
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
69
|
70
|
|
Overall Study
COMPLETED
|
56
|
66
|
|
Overall Study
NOT COMPLETED
|
13
|
4
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Stepped Care for Depression in Heart Failure
Baseline characteristics by cohort
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 12.2 • n=107 Participants
|
58.2 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
69 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
139 Participants
n=206 Participants
|
|
Education (12 years or less)
|
17 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Income ($30,000/year or less)
|
35 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
65 Participants
n=206 Participants
|
|
Married or partnered
|
26 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Left ventricular ejection fraction <45%
|
36 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
|
New York Heart Association (NYHA) class
|
44 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Antidepressant medication
|
31 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
16.9 units on a scale
STANDARD_DEVIATION 4.7 • n=99 Participants
|
16.2 units on a scale
STANDARD_DEVIATION 5.3 • n=107 Participants
|
16.5 units on a scale
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Beck Depression Inventory (BDI-2)
|
32.6 units on a scale
STANDARD_DEVIATION 8.3 • n=99 Participants
|
32.1 units on a scale
STANDARD_DEVIATION 9.2 • n=107 Participants
|
32.3 units on a scale
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Hamilton Rating Scale for Depression (HAM-D-17)
|
22.5 units on a scale
STANDARD_DEVIATION 5.6 • n=99 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 5.4 • n=107 Participants
|
22.6 units on a scale
STANDARD_DEVIATION 5.5 • n=206 Participants
|
|
Self-Care of Heart Failure Index: Maintenance
|
60.7 units on a scale
STANDARD_DEVIATION 15.7 • n=99 Participants
|
55.5 units on a scale
STANDARD_DEVIATION 16.2 • n=107 Participants
|
58.1 units on a scale
STANDARD_DEVIATION 16.1 • n=206 Participants
|
|
Self-Care of Heart Failure Index: Management
|
55.7 units on a scale
STANDARD_DEVIATION 22.2 • n=99 Participants
|
52.4 units on a scale
STANDARD_DEVIATION 22.6 • n=107 Participants
|
52.4 units on a scale
STANDARD_DEVIATION 22.0 • n=206 Participants
|
|
Self-Care of Heart Failure Index: Confidence
|
58.8 units on a scale
STANDARD_DEVIATION 23.7 • n=99 Participants
|
51.0 units on a scale
STANDARD_DEVIATION 23.3 • n=107 Participants
|
54.8 units on a scale
STANDARD_DEVIATION 23.7 • n=206 Participants
|
|
Beck Anxiety Inventory (BAI)
|
23.2 units on a scale
STANDARD_DEVIATION 12.3 • n=99 Participants
|
22.1 units on a scale
STANDARD_DEVIATION 13.2 • n=107 Participants
|
22.7 units on a scale
STANDARD_DEVIATION 12.7 • n=206 Participants
|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
|
45.9 units on a scale
STANDARD_DEVIATION 22.0 • n=99 Participants
|
46.5 units on a scale
STANDARD_DEVIATION 18.9 • n=107 Participants
|
46.2 units on a scale
STANDARD_DEVIATION 20.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory (BDI-2) Total Score
|
15.6 score on a scale
Standard Deviation 9.7
|
19.6 score on a scale
Standard Deviation 9.4
|
PRIMARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
|---|---|---|
|
Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
|
70.4 score on a scale
Standard Deviation 12.5
|
73.0 score on a scale
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
|---|---|---|
|
Beck Anxiety Inventory
|
12.5 score on a scale
Standard Deviation 9.3
|
15.1 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ)
|
63.7 score on a scale
Standard Deviation 16.9
|
61.2 score on a scale
Standard Deviation 57.0
|
SECONDARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Stepped Care for Depression
n=69 Participants
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.
|
Enhanced Usual Care
n=70 Participants
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.
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D-17)
|
12.5 score on a scale
Standard Deviation 5.7
|
15.0 score on a scale
Standard Deviation 4.9
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Stepped Care for Depression
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kenneth E. Freedland, PhD
Washington University School of Medicine in St. Louis
Phone: 314-286-1311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place