Stepped Care for Depression in Heart Failure

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-17

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Depressive Disorder, Major

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Stepped care for depression

Intervention Type BEHAVIORAL

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. 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stepped care for depression

Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No