Positive Psychology + Motivational Interviewing for Acute Coronary Syndrome

(PEACE-V Trial)

Overseen By Jeff C Huffman, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cognitive deficits, Depression, Arthritis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

280 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Positive Psychology + Motivational Interviewing for Acute Coronary Syndrome?

Research shows that Motivational Interviewing (MI) can improve patient satisfaction and help change health behaviors, which may be beneficial for patients with Acute Coronary Syndrome. Additionally, MI has been effective in improving mood and quality of life in stroke patients, suggesting it could have similar benefits for heart-related conditions. ^{1 2 3 4 5}

Is the Positive Psychology + Motivational Interviewing intervention safe for humans?

The Positive Psychology + Motivational Interviewing intervention has been found to be feasible and well-accepted in studies with cardiac patients, with high session completion rates and positive participant feedback, indicating it is generally safe for humans. ^{6 7 8 9 10}

How is the Positive Psychology-Motivational Interviewing treatment different from other treatments for acute coronary syndrome?

This treatment is unique because it combines positive psychology, which focuses on enhancing well-being and positive emotions, with motivational interviewing, a technique that helps people find the motivation to make positive changes. Unlike traditional treatments that may focus solely on physical recovery, this approach aims to improve both psychological well-being and physical activity levels, which are important for heart health. ^{6 8 11 12 13}

What is the purpose of this trial?

The focus of this study is to test the efficacy of a 12-week, remotely delivered, positive-psychology-motivational interviewing (PP-MI) intervention, with additional twice weekly text messages for a total of 24 weeks (with interactive, algorithm-driven, goal-focused text messages in the final 12 weeks), compared to post-acute coronary syndrome (ACS) treatment as usual, in a randomized trial of 280 post-ACS patients with low baseline physical activity.

Research Team

Jeff C Huffman, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people who've had a recent heart event (like a heart attack or unstable angina) and don't exercise much—less than 150 minutes of moderate activity per week. They must be able to read, write, and speak English, receive texts, and be physically able to work out unless another health issue prevents it.

Inclusion Criteria

You do less than 150 minutes of moderate to vigorous physical activity each week, as confirmed by a special device called an accelerometer.

I have had a heart attack or unstable angina.

Exclusion Criteria

I cannot read, write, or speak in English.

I cannot be physically active due to a condition like arthritis.

You have a medical condition that is likely to cause death within the next 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive a 12-week, phone-delivered PP-MI intervention with weekly phone sessions and twice weekly text messages

12 weeks

12 phone sessions

Initial Follow-up

Participants receive twice weekly text messages and are monitored for physical activity and psychological outcomes

12 weeks

1 visit (in-person) at 24 weeks

Extended Follow-up

Participants are monitored for long-term outcomes including cardiovascular health and major adverse cardiac events

24 weeks

2 visits (in-person) at 24 and 48 weeks

Treatment Details

Interventions

• Positive Psychology + Motivational Interviewing

Trial Overview The study tests if a program combining positive psychology with motivational interviewing can help patients after an acute coronary syndrome. It's delivered remotely over 12 weeks with supportive texts for another 12 weeks compared to the usual care post-heart event.

Participant Groups

Group I: Positive Psychology + Motivational Interviewing Experimental Treatment 1 Intervention

Each week, participants in the PP-MI intervention group will complete a PP activity and work towards a physical activity goal, then complete a phone session with a study trainer. Each phone session will include PP and goal setting portions. In the PP portion, the study trainer will (a) review the week's PP exercise, (b) discuss the rationale of the next week's PP exercise through a guided review of the PP-MI manual, and (c) assign the next week's PP exercise. In the goal-setting portion, the trainer will (a) review the participant's physical activity goal from the prior week, (b) discuss techniques for improving physical activity (e.g. tracking activity), and (c) help the participant to set a physical activity goal for the next week. Participants also will receive supplemental text messages throughout the 12 weeks of the intervention and during the initial follow-up period (Week 13-24).

Group II: Treatment as Usual Active Control 1 Intervention

Participants in the treatment as usual (TAU) arm will not receive any specific intervention, though they will be free to receive any post-ACS treatment.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

In a study involving 320 overweight or obese patients and 40 primary care physicians, patients reported significantly higher satisfaction when their physicians demonstrated empathy, with satisfaction rates of 29% for empathic physicians compared to 11% for less empathic ones (P = .004).

Patients whose physicians used reflective listening techniques felt more supported in their autonomy, with 46% reporting high autonomy support compared to 30% for those whose physicians did not use these techniques (P = .006).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician empathy and listening: associations with patient satisfaction and autonomy. Pollak, KI., Alexander, SC., Tulsky, JA., et al.[2022]

In a study of 411 stroke patients, those who received motivational interviewing (MI) showed a significant improvement in mood, with 48.0% reporting normal mood compared to 37.7% in the control group at 12 months poststroke.

Motivational interviewing also contributed to a reduction in mortality, with 6.5% of patients in the MI group dying compared to 12.8% in the control group, indicating that MI may enhance both psychological and physical outcomes after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 12-month effects of early motivational interviewing after acute stroke: a randomized controlled trial. Watkins, CL., Wathan, JV., Leathley, MJ., et al.[2022]

Training all clinic staff in motivational interviewing (MI) through a coaching model led to improved clinician satisfaction, reduced burnout, and enhanced self-rated MI skills among staff in intervention clinics, compared to control clinics.

Patient satisfaction significantly increased in the clinics where staff received MI training, indicating that this approach can positively impact both clinician and patient experiences in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices. Pollak, KI., Nagy, P., Bigger, J., et al.[2017]

Motivational interviewing significantly improved depression and quality of life in stroke patients within the first 12 months after the stroke, based on a meta-analysis of six studies involving 1419 participants.

However, the benefits did not persist at the 12-month mark, and motivational interviewing did not show any significant effect on alleviating anxiety among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-analysis of the Effect of Motivational Interviewing on Depression, Anxiety, and Quality of Life in Stroke Patients. Qiqi, N., Hangting, L., Jia, W., et al.[2023]

Motivational interviewing (MI) is an effective communication technique that helps patients engage in discussions about changing their health behaviors by addressing their ambivalence.

MI practitioners use specific skills and strategies to create a gap between a patient's current behaviors and their personal goals, facilitating a more productive conversation about health changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. Tooley, EM., Kolahi, A.[2022]

The combined positive psychology-motivational interviewing (PP-MI) intervention was feasible for post-acute coronary syndrome (ACS) patients, with an 84% session completion rate and high participant satisfaction ratings.

PP-MI led to significant improvements in positive affect and increased physical activity, with participants taking an average of 1842 more steps per day at 12 weeks and engaging in more moderate-vigorous activity at 24 weeks compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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., et al.[2022]

A randomized controlled trial involving 21 patients with implantable cardioverter defibrillators (ICDs) showed that a positive psychology intervention (Quality of Life Therapy) was feasible and well-accepted, with 71% attendance and 80% completion of homework assignments.

Participants in the Quality of Life Therapy group found their sessions significantly more helpful compared to those in the Heart Healthy Education group, suggesting that positive psychological approaches may enhance the well-being of ICD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators. Carroll, AJ., Christon, LM., Rodrigue, JR., et al.[2021]

An 8-week phone-based positive psychology intervention for patients recovering from acute coronary syndrome was found to be feasible and well-accepted, with 74% of participants completing most exercises and rating them highly for ease and utility.

Participants in the positive psychology intervention showed moderate improvements in positive affect, anxiety, and depression compared to a treatment as usual group, suggesting that such interventions could enhance psychological well-being in cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Positive Psychology Intervention for Patients with an Acute Coronary Syndrome: Treatment Development and Proof-of-Concept Trial. Huffman, JC., Millstein, RA., Mastromauro, CA., et al.[2022]

Psychological interventions (PIs) based on cognitive-behavioral therapy (CBT) and positive psychology therapy (PPT) significantly reduce the risk of cardiovascular events, myocardial infarction (MI), and angina in patients with coronary artery disease (CAD), based on a review of 25 trials involving 8119 participants.

While PIs showed benefits in reducing certain cardiovascular outcomes, they did not impact other primary outcomes or laboratory results, indicating that their effectiveness may be specific to certain clinical events rather than overall health metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of psychological interventions on clinical outcomes of coronary artery disease: Systematic review and meta-analysis. Magán, I., Jurado-Barba, R., Casado, L., et al.[2022]

In a study involving 34 patients with acute coronary syndrome, positive psychological states like optimism and positive affect were found to encourage healthier behaviors such as physical activity and healthy eating.

Gratitude was noted as a common positive state but showed little connection to the completion of health behaviors, suggesting that not all positive emotions equally influence health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive psychological states and health behaviors in acute coronary syndrome patients: A qualitative study. Huffman, JC., DuBois, CM., Mastromauro, CA., et al.[2021]

In a study of 128 post-acute coronary syndrome patients over 16 weeks, increased positive affect was linked to better adherence to health behaviors, particularly in physical activity, while optimism did not show a significant relationship.

These findings suggest that enhancing positive emotions through positive psychology interventions could be more effective in promoting health behavior adherence after an acute coronary event than focusing on optimism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it better to cultivate positive affect or optimism? Predicting improvements in medical adherence following a positive psychology intervention in patients with acute coronary syndrome. Duque, L., Brown, L., Celano, CM., et al.[2020]

Positive psychology interventions (PPIs) significantly improve mental well-being and reduce distress in patients with cardiovascular disease (CVD), based on a systematic review of 20 studies involving 1222 participants.

Despite the positive findings, many of the included studies had low quality, highlighting the need for more rigorous research to determine the most effective PPIs for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of positive psychology interventions on well-being and distress in patients with cardiovascular diseases: A systematic review and Meta-analysis. Tönis, KJM., Kraiss, JT., Linssen, GCM., et al.[2023]

A randomized trial involving 128 post-acute coronary syndrome (ACS) patients tested a positive psychology-based intervention, which was well accepted and led to significant improvements in physical activity and health behavior adherence over 16 weeks.

Booster sessions and motivational interviewing were particularly effective components, with booster sessions showing a trend towards increased physical activity and motivational interviewing linked to better adherence to health behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing a Positive Psychology Intervention to Promote Health Behaviors After an Acute Coronary Syndrome: The Positive Emotions After Acute Coronary Events III (PEACE-III) Randomized Factorial Trial. Celano, CM., Albanese, AM., Millstein, RA., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Physician empathy and listening: associations with patient satisfaction and autonomy. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

The 12-month effects of early motivational interviewing after acute stroke: a randomized controlled trial. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

Effect of teaching motivational interviewing via communication coaching on clinician and patient satisfaction in primary care and pediatric obesity-focused offices. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

A Meta-analysis of the Effect of Motivational Interviewing on Depression, Anxiety, and Quality of Life in Stroke Patients. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Motivating Behavioral Change. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Usefulness of a Positive Psychology-Motivational Interviewing Intervention to Promote Positive Affect and Physical Activity After an Acute Coronary Syndrome. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Implementation, feasibility, and acceptability of quality of life therapy to improve positive emotions among patients with implantable cardioverter defibrillators. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

A Positive Psychology Intervention for Patients with an Acute Coronary Syndrome: Treatment Development and Proof-of-Concept Trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of psychological interventions on clinical outcomes of coronary artery disease: Systematic review and meta-analysis. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Positive psychological states and health behaviors in acute coronary syndrome patients: A qualitative study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Is it better to cultivate positive affect or optimism? Predicting improvements in medical adherence following a positive psychology intervention in patients with acute coronary syndrome. [2020]

12. England pubmed.ncbi.nlm.nih.gov

The effects of positive psychology interventions on well-being and distress in patients with cardiovascular diseases: A systematic review and Meta-analysis. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Optimizing a Positive Psychology Intervention to Promote Health Behaviors After an Acute Coronary Syndrome: The Positive Emotions After Acute Coronary Events III (PEACE-III) Randomized Factorial Trial. [2019]