Stepped Care for Depression in Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure; Depressive Disorder, Major
• Interventions: Behavioral: Stepped care for depression

• Registration Number: NCT02997865
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Study Start: 2017-02-17
• Primary Completion: 2021-07-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-11-07
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-23
• Last Update Submitted: 2023-01-23
• Results First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped Care for Depression	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.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Behavioral Medicine Center Washington University; 🇺🇸 Saint Louis, Missouri, United States