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Completed

NCT Number: NCT02997865

Stepped Care for Depression in Heart Failure

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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Key information

Conditions

Heart Failure Cardiovascular Diseases Depressive Disorder Depressive Disorder, Major Heart Diseases Mental Disorders Mood Disorders

Age range

25 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Behavioral Medicine Center Washington University

St Louis, Missouri, 63108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable, clinically-documented New York Heart Association (NYHA) Class I-III heart failure.
  • Current major depressive episode.
  • Baseline Beck Depression Inventory (BDI-II) score 14 or greater

Exclusion criteria

  • Dementia or other significant cognitive or communication deficits
  • Terminal illness other than HF
  • Insurmountable logistical barriers to participation
  • Age less than 25 years
  • Current clinically significant substance abuse, bipolar disorder, schizophrenia, or other psychotic disorder
  • High risk of suicide
  • Current participation in non-study psychotherapy for depression or other psychiatric conditions
  • Initiation or modification of antidepressant medication treatment within past two months
  • Renal or hepatic conditions that would preclude the use of antidepressants.

Treatment and study plan

Stepped care for depression

Behavioral

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

Primary outcomes

  1. Beck Depression Inventory (BDI-2) Total Score

    Time frame: 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.

  2. Self Care of Heart Failure Index (SCHFI) Maintenance Subscale

    Time frame: 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 outcomes

  1. Beck Anxiety Inventory

    Time frame: 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.

  2. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 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.

  3. Hamilton Rating Scale for Depression (HAM-D-17)

    Time frame: 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.

  4. Actigraphy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: DASH-2

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2016
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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