NCT03122184: PEACE-IV

Positive Psychology for Acute Coronary Syndrome Patients

Completed NA Results posted Last updated 14 May 2020

What this trial tests

NA trial testing Positive Psychology + Motivational Interviewing in ACS - Acute Coronary Syndrome in 69 participants. Completed in 26 November 2018.

Timeline

1 May 2017

Primary endpoint
10 July 2018

26 November 2018

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	69
Start date	1 May 2017
Primary completion	10 July 2018
Estimated completion	26 November 2018
Sites	1 location across United States

Drugs / interventions tested

• Positive Psychology + Motivational Interviewing
• Motivational Interviewing Health Education

Conditions studied

• ACS - Acute Coronary Syndrome — all drugs for ACS - Acute Coronary Syndrome →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with ACS - Acute Coronary Syndrome. 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.

Feasibility of the PP-MI Based Health Behavior Intervention Primary · 24 weeks

Feasibility will be measured by examining the number of completed exercises.

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	10.0	± 3.9

Acceptability of the PP-MI Exercises: Utility Score Primary · Weeks 1-12

Participants will provide ratings of utility after each exercise, measured on a 10-point Likert scale (0=not at all helpful; 10=very helpful). Weekly utility ratings were averaged to provide an overall utility score of the exercises.

Utility of the PP component

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	8.0	± 2.3

Utility of the MI component

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	8.2	± 2.2

Acceptability of the PP-MI Exercises: Ease Score Primary · Weeks 1-12

Participants will provide ratings of ease after each exercise, measured on a 10-point Likert scale (0=very difficult; 10=very easy). Weekly ratings were averaged to provide an overall ease of the exercises.

Ease of the PP component

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	8.3	± 2.3

Ease of the MI component

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	8.1	± 2.4

Minutes of Moderate to Vigorous Physical Activity (Actigraph) Secondary · MVPA at 12 weeks and 24 weeks

ActiGraph GT3X+ step counters are validated as measures of physical activity and have been used in numerous studies of physical activity in patients with medical illness. In this trial, participants will wear the accelerometer for one week at 12 weeks, and another week at 24 weeks to assess the feasibility of doing so and to ensure adequate capture of physical activity. In our analysis, data on pre-ACS activity was collected using the International Physical Activity Questionnaire (IPAQ) to control for baseline activity.

MVPA at 12-week

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	33.0	± 19.0
Motivational Interviewing Health Education	23.2	± 26.2

MVPA at 24-week

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	34.6	± 22.9
Motivational Interviewing Health Education	18.1	± 11.9

Change in Medication Adherence Secondary · Change in score from Baseline to 12 weeks, 24 weeks

Measured by Self-Reported Medication Adherence (SRMA), a two-item self-report medication adherence scale measuring percentage of time (in 10% increments) patients report taking their heart medications in the past one and two weeks. Minimum: 0, Maximum:100. Change was calculated by subtracting the score at baseline from the score at 12 weeks and 24 weeks. Higher score indicates greater levels of medication adherence.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	5	± 2.2
Motivational Interviewing Health Education	5	± 2.2

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	0	± 0
Motivational Interviewing Health Education	-6	± 5.4

Change in Dietary Adherence Secondary · Change in score from Baseline to 12 weeks, 24 weeks

Measured by the MEDFICTS scale, a National Cholesterol Education Program-developed scale inquiring about saturated fat. Minimum= 0; Maximum= 216. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate lower levels of dietary adherence.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	-2.8	± 31.2
Motivational Interviewing Health Education	-17.6	± 21.5

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	2.1	± 33.8
Motivational Interviewing Health Education	-7.7	± 25.6

Change in Positive Affect Secondary · Change in score from Baseline to 12 weeks, 24 weeks

The positive affect items on the Positive and Negative Affect Schedule (PANAS), a well-validated scale used in other intervention trials and in patients with medical illnesses, will be used to measure positive affect. (Range: 10-50). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of positive affect.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	8.8	± 6.0
Motivational Interviewing Health Education	4.9	± 6.5

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	9.5	± 6.8
Motivational Interviewing Health Education	2.2	± 6.6

Change in Trait Optimism Secondary · Change in score from baseline to 12 week, 24 week

Life Orientation Test-Revised is a well-validated 6-item instrument used to measure dispositional optimism. (Range: 0-24) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of optimism.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	2.2	± 3.8
Motivational Interviewing Health Education	2.0	± 5.3

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	1.7	± 5.9
Motivational Interviewing Health Education	2.8	± 3.8

Change in State Optimism Secondary · Change of score from Baseline to 12 weeks, 24 weeks

Measured by the State Optimism Scale developed by our team (SOM), which aims to capture the changeable nature of optimism based on time and situation. Minimum:7, Maximum:35. The higher number indicates a greater level of optimism. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks.

Change in SOM at 12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	5.3	± 6.5
Motivational Interviewing Health Education	-.1	± 6.8

Change in SOM at 24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	6.0	± 7.1
Motivational Interviewing Health Education	.6	± 4.6

Changes in HADS-A Scores Secondary · Change in score from Baseline to 12 week, 24 week

The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients. (Range: 0-21) Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate higher levels of anxiety.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	-2.8	± 3.3
Motivational Interviewing Health Education	-1.3	± 2.8

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	-2.3	± 3.8
Motivational Interviewing Health Education	-1.9	± 2.0

Change in HADS-D Scores Secondary · Change in score from Baseline to 12 week, 24 week

The Hospital Anxiety and Depression Scale will be used to measure depression and anxiety. This is a well-validated scale with few somatic symptom items that can confound mood/anxiety assessment in medically-ill patients.(Range: 0-21). Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate worse outcome (i.e. greater levels of depression).

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	-1.8	± 2.8
Motivational Interviewing Health Education	.5	± 2.5

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	-1.5	± 3.3
Motivational Interviewing Health Education	-0.8	± 2.2

Change in Physical Function Secondary · Change of score from Baseline to 12 week, 24 week

Measured by the Duke Activity Status Index (DASI), a 12-item questionnaire that inquires about activities of daily living, basic physical activity, and more strenuous physical function to gauge overall functional capacity. Minimum: 0, Maximum: 58.2. Change was calculated by subtracting the score at baseline from the score at 12 and 24 weeks. Higher scores indicate greater levels of functional capacity.

12 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	9.7	± 11.7
Motivational Interviewing Health Education	4.4	± 13.3

24 weeks

Group	Value	95% CI
Positive Psychology + Motivational Interviewing	14.1	± 13.0
Motivational Interviewing Health Education	4.9	± 10.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Positive Psychology + Motivational Interviewing

Serious: 11/24 (46%)

Deaths: 0/24

Motivational Interviewing Health Education

Serious: 11/23 (48%)

Deaths: 0/23

Serious adverse events (19 terms)

Reaction	System	Positive Psychology + Moti…	Motivational Interviewing …
Unexpected Coronary Artery Syndrome	Cardiac disorders	—	—
Unexpected chest and back pain	General disorders	—	—
Unexpected aneurysm	General disorders	—	—
Unexpected NSTEMI	Cardiac disorders	—	—
Unexpected hospital admission due to alt ms	General disorders	—	—
Unexpected fever	General disorders	—	—
Unexpected hypotension	Cardiac disorders	—	—
Unexpected sepsis	General disorders	—	—
Unexpected GI bleed	General disorders	—	—
Unexpected calculus of gallbladder	General disorders	—	—
Unexpected melena	General disorders	—	—
Unexpected mass	General disorders	—	—
Unexpected rectal bleeding	General disorders	—	—
Lymphoma	General disorders	—	—
Unexpected A-FIB	General disorders	—	—
Unexpected Carpal Tunnel Syndrome	General disorders	—	—
Unexpected eye damage	Eye disorders	—	—
Unexpected blood in stool	General disorders	—	—
Unexpected malignant neoplasm of colon	General disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Positive Psychology + Moti…	Motivational Interviewing …
Abdominal pain	General disorders	—	—
Chest pain	Cardiac disorders	—	—
Allergic reaction	General disorders	—	—
Stomach cramps and vomiting	General disorders	—	—
Throat swelling	General disorders	—	—
Chest discomfort	Cardiac disorders	—	—
Unexpected balance issues	General disorders	—	—

Most-reported serious reactions: Unexpected Coronary Artery Syndrome, Unexpected chest and back pain, Unexpected aneurysm, Unexpected NSTEMI, Unexpected hospital admission due to alt ms, Unexpected fever, Unexpected hypotension, Unexpected sepsis.

Data from ClinicalTrials.gov NCT03122184 adverse events section.

Sponsor's own description

This is a randomized controlled pilot trial in approximately 50 acute coronary syndrome patients to determine if a 12 week, telephone-delivered, combined positive psychology-motivational interviewing intervention is feasible and more effective than a motivational interviewing health education program at improving health behaviors and other outcomes. The investigators hypothesize that the intervention will be associated with better mental and physical health outcomes and better health behavior adherence compared to the motivational interviewing health education program.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome.
   Huffman JC, Feig EH, Millstein RA, Freedman M, et al · · 2019 · cited 51× · PMID 30979409 · DOI 10.1016/j.amjcard.2019.03.023
2. Association of Midlife Status With Response to a Positive Psychology Intervention in Patients With Acute Coronary Syndrome.
   Feig EH, Celano CM, Massey CN, Chung WJ, et al · · 2021 · cited 4× · PMID 32665150 · DOI 10.1016/j.psym.2020.06.002
3. The Mental Health-Acute Coronary Syndrome Continuum: Bidirectional Pathophysiological Links and Clinical Implications.
   Herlaș-Pop A, Radu AF, Radu A, Bungau GS, et al · · 2026 · PMID 41892853 · DOI 10.3390/medsci14010138