Problem-solving to Improve Depressive Symptoms and Self- Care Among Recently Hospitalized Adults With Heart Failure

NCT03606304 | Withdrawn

• 1 other identifier: SON2018-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to examine the feasibility of providing a problem-solving therapy-based intervention to improve both depressive symptoms and heart failure self-care specifically after hospital discharge. This is because the period after hospital discharge is critical to long-term recovery, overall quality of life, and prevention of adverse outcomes, such as hospital readmission.

Conditions

Heart Failure; Depression

Keywords

self-care; quality of life

Outcome Measures

Primary Outcomes (1)

• Problem-solving skills

  problem solving skills as measured by the Social Problem-Solving Inventory-Revised (Short) SPSI-R:S: There are 25 items measuring 5 components: Positive Problem Orientation, Negative Problem Orientation, Rational Problem Solving, Impulsivity/Carelessness Style, and Avoidance Style. Validated norms are provided by age group and raw scores are plotted for conversion to standard scores. Higher scores reflect greater intensity of the construct measured.

  6 months post-discharge

Secondary Outcomes (4)

• Behavioral Activation for Depression

  6 months post-discharge

• Depressive symptoms

  6 months post-discharge

• Depressive symptoms

  6 months post-discharge

• Heart Failure Self-care

  6 months post-discharge

Study Arms (1)

Problem-solving therapy

EXPERIMENTAL

The intervention is based on an established PST protocol for medical patients, with an additional focus on HF to link depressed mood to impaired HF self-care. Seven steps are included: 1) select and define the problem; 2) establish realistic and achievable goals for problem resolutions; 3) generate multiple solution alternatives (brainstorming); 4) implement decision-making guidelines (pros and cons); 5) evaluate and choose the solutions; 6) implement the preferred solution(s); and 7) evaluate the outcome.

Behavioral: Problem-solving therapy

Interventions

Problem-solving therapy BEHAVIORAL

See previous

Problem-solving therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• age ≥ 65;
• having a primary diagnosis of HF (New York Heart Association \[NYHA\] Class I, II, III) of the index hospitalization;
• having clinically significant depressive symptoms (PHQ-9 score≥10) at both hospital discharge and four weeks after hospital discharge;
• inadequate HF self-care ability (any domain score in the Self-Care of Heart Failure Index \[SCHFI\]≤70/100); and
• having normal or mildly impaired cognitive function (score of Montreal Cognitive Assessment \[MoCA\]: 23-30).

You may not qualify if:

• being listed for an implanted ventricular assist device, heart transplant or currently receiving Milrinone infusion (indicating decompensated HF);
• receiving hospice care or end-of-life care;
• having diagnoses of the following, a) delirium or advanced Alzheimer's disease, b) malignant cancer, coronary artery disease requiring surgery or angioplasty, renal disease on dialysis in the present or within the past two years, c) severe psychotic disorder or suicidal ideation (or scored "0" in PHQ-9 item #9);
• initiation or titration of antidepressants in the past 8 weeks; or
• inability to give informed consent and/or to communicate verbally in English.

Sponsors & Collaborators

• University of Rochester: lead

MeSH Terms

Conditions

Heart Failure; Depression

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Study Officials

• Tiffany Gommel, MS, CIM, CIP

  University of Rochester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a single group, pre-/post-test design with a 6 month follow-up period. There are 8 weekly intervention sessions, each approximately 30-45 minutes long. The 3 telephone booster sessions occurring every two months during the followup phase are estimated to last 20 minutes.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 30, 2018
• Study Start: May 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share