NCT04158219: H^3

Healthy Heart Habits

Completed Phase 1, PHASE2 Results posted Last updated 10 March 2022

What this trial tests

Phase 1, PHASE2 trial testing Behavioral activation for health and depression (BA-HD) in Acute Coronary Syndrome in 8 participants. Completed in 24 February 2021.

Timeline

15 November 2019

Primary endpoint
24 February 2021

24 February 2021

Quick facts

Lead sponsor	Hennepin Healthcare Research Institute
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 November 2019
Primary completion	24 February 2021
Estimated completion	24 February 2021
Sites	1 location across United States

Drugs / interventions tested

• Behavioral activation for health and depression (BA-HD)

Conditions studied

• Acute Coronary Syndrome — all drugs for Acute Coronary Syndrome →
• Depression — all drugs for Depression →

Sponsor

Hennepin Healthcare Research Institute

Who can join

Adults 18 to 75, any sex, with Acute Coronary Syndrome or Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acceptability Measured by the Client Satisfaction Questionnaire Primary · At 12 weeks

This will be assessed at the end of the intervention using the 8-item Client Satisfaction Questionnaire. score range 8-32 with higher score indicating greater satisfaction.

Group	Value	95% CI
Treatment	30.57	± 2.23

Treatment Engagement Measured by Sessions Attended Primary · At 12 weeks

Throughout the study we will measure engagement by tracking attendance of treatment sessions.

Group	Value	95% CI
Treatment	8.65	± 2.77

Study Retention Measured by the Number of Participants Who Complete the Follow-up Assessments Secondary · At 12 weeks

Study retention will be tracked by measuring the number of participants who complete the follow-up assessments

Group	Value	95% CI
Treatment	7

Depression Symptoms as Measured by PHQ-9 (Patient Health Questionnaire-9) Secondary · At 12 weeks

Depression symptoms will be measured by Patient Health Questionnaire, 9-item.Score range is 0-27 with higher scores indicating higher depression symptoms.

Baseline

Group	Value	95% CI
Treatment	8.29	± 5.12

12 Weeks

Group	Value	95% CI
Treatment	4.86	± 3.89

Depression Symptoms as Measured by CES-D 10 (Center for Epidemiological Studies Depression Scale Revised) Secondary · At 12 weeks

Depression symptoms will also be measured by the Center for Epidemiological Studies Depression scale 10-item. Score range is 0-30 with higher scores indicating higher depression symptoms.

Baseline

Group	Value	95% CI
Treatment	11.43	± 4.72

12 Weeks

Group	Value	95% CI
Treatment	8.57	± 4.54

Composite Behavioral Risk Factor Adherence MOS (Medical Outcomes Study Patient Adherence Questionnaire) Secondary · At 12 weeks

The Medical Outcomes Study Patient Adherence Questionnaire will be used to assess adherence to behavior change goals.10 items related to cardiac health will be scored. Items are rated on a 1-6 scale. Because not all items will be relevant to all participants, the average score across the relevant items for each participant will be presented. Higher scores indicating greater adherence to healthcare provider recommendations.

Baseline

Group	Value	95% CI
Treatment	3.75	± .94

12 weeks

Group	Value	95% CI
Treatment	4.53	± .70

Sponsor's own description

Approximately 350,000 Acute Coronary Syndrome (ACS) patients experience significant depression symptoms each year in the US. Post-ACS depressed mood interferes with patients making necessary changes to behavioral risk factors (e.g., smoking cessation) and predicts poor medical outcomes. The proposed study will develop an integrated depression and behavioral risk factor reduction intervention for secondary prevention post-ACS through an open trial of 20 patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The development and pilot testing of a behavioral activation-based treatment for depressed mood and multiple health behavior change in patients with recent acute coronary syndrome.
   Gathright EC, Vickery KD, Ayenew W, Whited MC, et al · · 2022 · cited 6× · PMID 35113860 · DOI 10.1371/journal.pone.0261490