DASH-2: Stepped Care for Depression in Heart Failure

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02997865

Collaborator

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

139

Enrollment

Location

Arms

58.4

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Depressive Disorder, Major	Behavioral: Stepped care for depression	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

139 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Stepped Care for Depression in Heart Failure

Actual Study Start Date :

Feb 17, 2017

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Stepped care for depression Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

Behavioral: Stepped care for depression

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

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

Beck Depression Inventory (BDI-II) total score [16 weeks]
Self-reported severity of depression
Self Care of Heart Failure Index (SCHFI) Maintenance subscale [16 weeks]
Self-reported heart failure self-care behaviors

Secondary Outcome Measures

Beck Anxiety Inventory [16 weeks]
Self-reported severity of anxiety symptoms
Kansas City Cardiomyopathy Questionnaire (KCCQ) [16 weeks]
Heart failure-related quality of life
Hamilton Rating Scale for Depression (HAM-D-17) [16 weeks]
Interviewer-rated severity of depression symptoms
Actigraphy [16 weeks]
Physical activity level

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Stable, clinically-documented Class I-III heart failure.
Current major depressive episode.
Baseline 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.