Clinical trial NCT02997865: Stepped Care for Depression in Heart Failure
Official title: Stepped Care for Depression in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Depressive Disorder, Major
Keywords: heart failure
depressive disorder, major
cognitive therapy
self-care
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2016-12-20
Enrollment: 139
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck Depression Inventory (BDI-2) Total Score
timeFrame: 16 weeks
measure: Self Care of Heart Failure Index (SCHFI) Maintenance Subscale
timeFrame: 16 weeks
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: 16 weeks
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 16 weeks
measure: Hamilton Rating Scale for Depression (HAM-D-17)
timeFrame: 16 weeks
measure: Actigraphy
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Behavioral Medicine Center Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Kenneth E Freedland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Freedland KE, Skala JA, Carney RM, Steinmeyer BC, Rubin EH, Rich MW. Sequential Interventions for Major Depression and Heart Failure Self-Care: A Randomized Clinical Trial. Circ Heart Fail. 2022 Aug;15(8):e009422. doi: 10.1161/CIRCHEARTFAILURE.121.009422. Epub 2022 Jun 21.