Stepped Care for Depression in Heart Failure

Heart Failure Clinical Trial

— DASH-2  

Official title:

Stepped Care for Depression in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02997865
• Other study ID #: R01HL131524
• Secondary ID: R01HL131524
• Status: Completed
• Phase: N/A
• Start date: February 17, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: December 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Heart Failure

Intervention

Behavioral:
• Stepped care for depression
Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.

Locations

Country	Name	City	State
United States	Behavioral Medicine Center Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI-2) Total Score	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.	16 weeks
Primary	Self Care of Heart Failure Index (SCHFI) Maintenance Subscale	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.	16 weeks
Secondary	Beck Anxiety Inventory	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.	16 weeks
Secondary	Kansas City Cardiomyopathy Questionnaire (KCCQ)	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.	16 weeks
Secondary	Hamilton Rating Scale for Depression (HAM-D-17)	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.	16 weeks
Secondary	Actigraphy	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.	16 weeks