MBCT Delivered Via Group Videoconferencing for ACS Syndrome Patients With Depressive Symptoms

Depression Clinical Trial

Official title:

Mindfulness-Based Cognitive Therapy Delivered Via Group Videoconferencing for Acute Coronary Syndrome Patients With Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231097
• Other study ID #: 2020P000045
• Status: Completed
• Phase: N/A
• Start date: April 24, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brief Summary: The aim of this study is to explore the initial feasibility and acceptability of (a) Mindfulness-Based Cognitive Therapy (MBCT) adapted for ACS patients; (b) the group videoconferencing delivery medium; and (c) dried blood spot research procedures, to inform refinements for a subsequent pilot RCT.

Description:

The current study will employ an open pilot trial to determine the initial feasibility and acceptability of a targeted, virtual MBCT intervention for ACS patients. The investigators plan to enroll approximately N=20 patients (2 cohorts of 10 participants/per cohort, accounting for 20% anticipated lost to follow-up). The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. Participants will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30 minutes). Participants will be recruited through the the hospital's clinical data registry, advertisements (e.g., flyers, brochures) placed throughout the hospital, direct provider referrals, and from inpatient cardiac units. Patients who express interest in the study will be asked complete an eligibility screening. Eligible patients agreeable with study participation will then complete a written consent with study staff prior to enrollment. Participants will be enrolled in one of two MBCT intervention cohorts and expected to participate in 8-weekly, 1.5-hour virtual sessions, in conjunction with approximately 30 minutes of at-home daily practice. A licensed mental health provider (e.g., LICSW, PhD) trained in the MBCT protocol will deliver the intervention. The MBCT intervention will be delivered Zoom, a secure, HIPPA-compliant video-conferencing software. Study assessments will include a battery of self-report surveys administered at baseline, post-intervention, and 3-month follow-up; session satisfaction surveys administered after each intervention session; post-intervention individual exit interviews (conducted via telephone or videoconference); blood spot samples self-collected by participants at baseline, post-intervention, and 3-month follow-up (submitted to the research team via paper mail); and home practice logs submitted between each intervention session. Primary outcomes for the intervention are feasibility and acceptability. Data collected from the study will be used to assist in the development of future RCTs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 1, 2021
• Est. primary completion date: February 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Lifetime ACS per medical record and/or patient confirmation

2. Current elevated depression symptoms (PHQ-9>5)

3. Age 35-85 years

4. Access to high-speed internet

Exclusion Criteria:

1. Active suicidal ideation or past-year psychiatric hospitalization (per patient report and/or medical record review)

2. Non-English-speaking

3. Cognitive impairments preventing informed consent per medical record review and/or cognitive Screen < 4

4. Patient deemed unable to complete the study protocol or has a condition that would likely interfere with the study

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Depression
• Infarction
• Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation MI
• STEMI
• Syndrome
• Unstable Angina

Intervention

Other:
• MBCT intervention for ACS patients
The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. Participants involved in the intervention will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30 minutes).

Locations

Country	Name	City	State
United States	Mongan Institute: Health Policy Research Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility: Percent of Participants Who Consent to Screening	Feasibility outcomes for recruitment will include: >70% of patients reached consent to screening	6 months
Primary	Recruitment Feasibility: Percent of Participants Meeting Screening Criteria	Feasibility outcomes for recruitment will include: >70% meet screening criteria	6 months
Primary	Recruitment Feasibility: Percent of Eligible Patients Who Consent	Feasibility outcomes for recruitment will include: >70% of eligible consent to the study	6 Months
Primary	MBCT Feasibility: Percent of Participants Adherent to the MBCT Intervention	MBCT feasibility will be measured by: >75% session attendance (i.e., percent who attend at least 6/8 intervention sessions)	6 Months
Primary	MBCT Feasibility: Percent of Participants Retained at Post-Intervention	MBCT feasibility will be measured by: >75% post-intervention assessments completed	3 Months
Primary	Videoconferencing Feasibility: Percent of Connections Dropped During Sessions	Videoconferencing feasibility will be assessed by: < 20% of connections dropped during session	6 Months
Primary	Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Baseline	Blood spot feasibility will be assessed by: >75% of participants submitting samples at baseline	6 months
Primary	Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Sample at Post-Intervention	Blood spot feasibility will be assessed by: >75% of participants submitting samples at post-intervention	6 Month
Primary	Blood Spot Feasibility: Percent of Participants Submitting Blood Spot Samples at Follow-up	Blood spot feasibility will be assessed by: >60% of participants submitting samples at follow-up	6 Months
Primary	Blood Spot Feasibility: Percent of Adequate Blood Spot Samples Submitted	Blood spot feasibility will be assessed by: 80% of samples of adequate quality for processing.	6 Months
Primary	MBCT Acceptability: Helpfulness for Mood	Ratings of how helpful the MBCT sessions were for improving mood (1 = not at all helpful to 10 = very helpful), with acceptability defined as Mean >= 7.5	6 months
Primary	MBCT Acceptability: Usefulness of Session Components	The average usefulness ratings for session components on a scale of 1 = not at all useful to 10 = very useful, with mean >= 7.5 being considered acceptable	6 months
Primary	Videoconferencing Acceptability: Ratings of Videoconferencing Ease of Use	Videoconferencing acceptability will be assessed in terms of ease of use (1= very much, 10 = not at all; M >= 7.5)	6 Months
Primary	Videoconferencing Acceptability: Ratings of Videoconferencing Quality Surveys)	Videoconferencing acceptability will be assessed in terms of video quality of mindfulness videoconference sessions (1= Very Poor to 10 = Very Good, M>7.5)	6 Months
Primary	Videoconferencing Acceptability: Ratings of Videoconferencing Satisfaction	Videoconferencing acceptability will be assessed in overall satisfaction of use (1 = not at all satisfied to 10 = very satisfied, M > 7.5)	6 Months
Primary	Blood Spot Acceptability: Ease of Blood Spot Collection	Blood spot acceptability will be assessed by ratings of ease of blood spot collection (1 = not at all, 10 = very easy; M>7.5)	Average rating for ease of data submission from blood spot collection through out all groups
Primary	Blood Spot Acceptability: Discomfort of Blood Spot Collection	Blood spot acceptability will be assessed by ratings of level of pain during blood spot collection, (1=Very much pain, 10=Very little pain; M>=7.5).	6 Months
Secondary	Patient Health Questionnaire (PHQ-9)	This is a 9-item scale that measures depression. The scoring scale ranges from 0, not at all, to 3, nearly every day. The scoring values range from 0-18, where high values represent higher levels of depression and lower values represent lower levels of depression. Changes of >= 3 points from before to after the intervention represent clinically meaningful change. The outcome is the % of participants who report clinically meaningful change	6 months