Helping Others Toward Positive Emotions in People With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Behavioral: Brief Cognitive Therapy Intervention

• Registration Number: NCT01275742
• Lead Sponsor: Rebecca L. Dekker, PhD, RN, APRN

Brief Summary

Heart failure (HF) affects 5 million people in the US and is the most common cause of hospitalization in elderly adults. One-third of patients who are hospitalized with HF have major depression. Depressed HF patients have double the rates of morbidity and/or mortality and worse health-related quality of life than non-depressed HF patients. The investigators previous pilot research suggests that a brief Cognitive Therapy (CT) intervention may improve short-term cardiac survival among depressed hospitalized HF patients compared to non-depressed HF patients who received usual care. Therefore, the investigators will conduct a larger study to evaluate the effects of the intervention on longer cardiac event-free survival, symptoms of depression, health-related quality of life, and stress levels in patients with HF. The investigators hypothesize that patients in the intervention group will experience longer cardiac event-free survival, lower levels of depressive symptom, better health-related quality of life, and lower salivary cortisol levels at follow-up than patients who receive usual care.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Admitted to the hospital with a primary or secondary diagnosis of congestive heart failure OR admitted to the hospital for cardiac reasons and has a history of chronic heart failure
• American College of Cardiology/ American Heart Association Stage C HF
• 21 years or older

Exclusion Criteria

• Co-existing terminal illness likely to be fatal within the next 12 months
• End-stage HF (defined as American College of Cardiology Stage D HF)
• Cognitive impairment that precludes the ability to give informed consent
• Active suicidality (defined choosing option 1, 2 or 3 on Item 9 of the PHQ-9)
• History of the death of a spouse or child within the past month
• History of psychotic illness or bipolar illness
• Current alcohol dependence or other substance abuse
• Non-English speaking or possessing any other communication barrier

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Brief Cognitive Therapy Intervention	-

Primary Outcome Measures

Name	Time	Method
Cardiac event-free survival	Three months to five years	To compare cardiac event-free survival at 3 months, 6 months, and up to five years between patients with HF and depressive symptoms who receive a brief cognitive therapy intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).

Secondary Outcome Measures

Name	Time	Method
Salivary cortisol	1 week, 3 months, and 6 months	Compare salivary cortisol at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
No depressive symptom comparison group	1 week, 3 months, and 6 months	Compare cardiac event-free survival, depressive symptoms, health-related quality of life, and salivary cortisol levels between the depressive symptom intervention group and patients with HF and no depressive symptoms who receive usual care (no depressive symptom group) at 1-week, 3 months, and 6 months.
Depressive symptoms	1 week, 3 months, and 6 months	Compare depressive symptoms at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).
Salivary vs. serum biomarkers	Baseline	Compare levels of salivary cortisol, BNP, CRP and IL-6 at baseline between patients with and without depressive symptoms, and determine whether the salivary measures of BNP, CRP, and IL-6 are correlated with serum measurement of these biomarkers.
Health-related quality of life	1 week, 3 months, and 6 months	Compare health-related quality of life at 1-week, 3 months, and 6 months between patients with HF and depressive symptoms who receive a brief CT intervention (depressive symptom intervention group) and patients with HF and depressive symptoms who receive usual care (depressive symptom usual care group).

Trial Locations

Locations (1)

University of Kentucky Chandler Medical Center; 🇺🇸 Lexington, Kentucky, United States