Piloting Text Messages to Promote Positive Affect and Physical Activity

NCT04077229 | Completed

• 1 other identifier: 2016P001472
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of the study is to assess the feasibility and acceptability of a pilot one-arm project delivering text messages related to positive psychology (PP) activities (e.g., recalling positive events) and health behavior text messages (e.g. having a heart-healthy diet, becoming more physically active). The messages will be sent for 4 weeks among patients with a prior acute coronary syndrome (ACS).

Conditions

Acute Coronary Syndrome

Keywords

ACS; Text Message; Positive Psychology; Health Behavior

Outcome Measures

Primary Outcomes (3)

• Percentage of text messages successfully delivered to participants

  Feasibility will be measured by calculating the percentage of text messages successfully delivered to participants.

  4 weeks

• Participant burden

  Mean ratings of the intervention's burden, as reported by participants on a 0-10 Likert-type scale (0= not burdensome at all; 10= extremely burdensome).

  4 weeks

• Self-reported utility of the intervention

  Mean ratings of the intervention's utility, as reported by participants on a 0-10 Likert-type scale (0= not helpful at all; 10= extremely helpful).

  4 weeks

Secondary Outcomes (18)

• Change in Positive Affect at 4 weeks

  Change in positive affect from baseline to 4 weeks

• Change in Positive Affect at 8 weeks

  Change in positive affect from baseline to 8 weeks

• Change in Optimism at 4 weeks

  Change in optimism from baseline to 4 weeks

• Change in Optimism at 8 weeks

  Change in optimism from baseline to 8 weeks

• Change in Determination at 4 weeks

  Change in determination from baseline to 4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

A total of 28 intervention text messages (1/day for 4 weeks) will be sent to participants following the baseline self-report assessment. After each message is sent, participants will receive a second text message asking them to rate the utility of the message. Following the 4-week intervention, participants will complete the same self-report assessments as in the baseline assessment (via phone) and will provide feedback about the program. Finally, 4 weeks later (at 8 weeks), participants will repeat the self-report questionnaires by phone.

Behavioral: Intervention arm: Text Message Intervention

Interventions

Intervention arm: Text Message Intervention BEHAVIORAL

Participants will receive a combination of messages promoting both psychological well-being and education /support around health behavior adherence, such as physical activity or diet. In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and PP (Positive Psychology) messages. In the second part of the study, participants will first receive a set of 14 pre-selected daily messages that contain a broad range of attributes to allow sufficient participant feedback to clearly identify preferences. After the first 14 messages, new messages will be selected based on the prior preferences of participants.

Intervention

Eligibility Criteria

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

You may qualify if:

• Prior acute coronary syndrome.
• Acute myocardial infarction (MI):
• Elevation of cardiac biomarkers (cardiac troponin T) in addition to one or more of the following:
• symptoms of ischemia (e.g., acute chest pain)
• ischemic changes on electrocardiogram
• imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
• Unstable angina (UA):
• crescendo angina
• new onset (within 1 month) angina with minimal exertion
• angina with minimal exertion or at rest.
• Ability to receive text messages via cellular phone.

You may not qualify if:

• A periprocedural ACS
• Terminal illness
• An unrelated condition limiting physical activity
• An inability to communicate in English, or
• cognitive disorder assessed by 6-item cognitive screen

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Jeff Huffman

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome; Health Behavior

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

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: Associate Professor of Psychiatry, Harvard Medical School

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 4, 2019
• Study Start: September 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

US (1)