Researching Emotions And Cardiac Health: Phase III

NCT03220204 | Completed Results DMC

• 1 other identifier: 5K23HL123607-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this study is to examine the feasibility, acceptability, and preliminary impact of a 12-week, telephone-delivered, positive psychology (PP)-based health behavior intervention in a group of patients with mild to moderate heart failure (HF), compared to a motivational interviewing- (MI-) based education condition and treatment as usual (TAU).

Conditions

Congestive Heart Failure; Emotions; Patient Compliance

Keywords

Heart Failure; Positive Psychology; Adherence to Health Behaviors

Outcome Measures

Primary Outcomes (1)

• Feasibility of the PP-based Health Behavior Intervention

  Feasibility will be measured by examining the number of completed exercises for individuals randomized to the Positive Psychology (PP)-based intervention.

  Change between baseline and 12 weeks

Secondary Outcomes (15)

• Acceptability of the Exercises

  12 weeks

• Immediate Impact of the Exercises

  Weekly, up to 12 weeks

• Change in PANAS Scores (Primary Psychological Outcome)

  Baseline, 12 weeks, and 24 weeks

• Changes in LOT-R Scores

  Baseline, 12 weeks, and 24 weeks

• Changes in SOM Scores

  Baseline, 12 weeks, and 24 weeks

Study Arms (3)

PP-based health behavior intervention

EXPERIMENTAL

Participants will undergo a 12-week, Positive Psychology (PP)-based health behavior intervention. Each weekly session will include (a) a review of the week's PP exercise, (b) a discussion of the rationale of the next week's PP exercise through a guided review of the PP manual, and (c) assignment of the next week's PP exercise. Additionally for the goal-setting portion, participants will (a) review their goals and behaviors from the prior week, (b) discuss techniques for improving health behavior adherence (e.g., monitoring physical activity, reading nutrition labels), and (c) set goals for the next week.

Behavioral: PP-based health behavior intervention

MI-based educational control condition

EXPERIMENTAL

Participants will undergo 12 weekly phone sessions to learn about a different health behavior topic related to cardiac health. This Motivational Interviewing (MI)-based educational control condition will introduce these participants to motivational interviewing topics in concert with the health behavior education topics.

Behavioral: MI-based educational control condition

Treatment as Usual (TAU)

NO INTERVENTION

Participants in the Treatment as Usual (TAU) group will not receive any interventions between the baseline visit and follow-up visits.

Interventions

PP-based health behavior intervention BEHAVIORAL

The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.

PP-based health behavior intervention

MI-based educational control condition BEHAVIORAL

The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.

MI-based educational control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with NYHA class I, II, or III HF admitted to an MGH inpatient unit or outpatients at the MGH Heart Center or MGH-affiliated primary care clinic. Patients with NYHA class IV HF have ongoing HF symptoms at rest, making it difficult for them to increase physical activity and other health behaviors; therefore, they will not be included. HF diagnosis will be confirmed via chart review and with the patient's treatment team as needed.
• Suboptimal adherence to health behaviors. This will be defined as a total score of ≤15 on three Medical Outcomes Study Specific Adherence Scale (MOS) items regarding diet/exercise/medications. The MOS has been used in multiple prior studies assessing adherence in cardiac patients, including our own studies in this population. This threshold score on the MOS will ensure that all participants will have the potential to improve their health behaviors.

You may not qualify if:

• Cognitive deficits impeding a participant's ability to provide informed consent or participate, assessed via a 6-item cognitive test that is sensitive and specific for screening for cognitive impairment in research participants.
• Medical conditions precluding interviews or likely to lead to death within 6 months.
• Inability to speak English, inability to read or write, inability to walk, or lack of a telephone.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Celano CM, Freedman ME, Harnedy LE, Park ER, Januzzi JL, Healy BC, Huffman JC. Feasibility and preliminary efficacy of a positive psychology-based intervention to promote health behaviors in heart failure: The REACH for Health study. J Psychosom Res. 2020 Dec;139:110285. doi: 10.1016/j.jpsychores.2020.110285. Epub 2020 Oct 29.

  PMID: 33160091 DERIVED

MeSH Terms

Conditions

Heart Failure; Patient Compliance

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Christopher Celano
• Organization: Massachusetts General Hospital

ccelano@partners.org

617-726-6485

Study Officials

• Christopher Celano, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating study staff will be aware of the participant's treatment condition. However, follow-up assessments will be performed by a study staff member that is masked to the participant's treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Psychiatrist

Model Details: Randomized, single-blinded, controlled trial

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: September 1, 2017
• Primary Completion: May 20, 2019
• Study Completion: September 9, 2019
• Last Updated: August 30, 2021
• Results First Posted: April 3, 2020

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)