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Heart-Smile Training Intensive Introduction Program (HST-IIP)

Primary Purpose

Depression

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Heart-Smile Training Intensive Introduction Program (HST-IIP)

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Sufficient English fluency to understand procedures and questionnaires
Ability to provide informed consent
Mild to moderately severe depression (CAT-DI score 35-75) (Achtyes et al., 2015; Gibbons et al., 2012)

Exclusion Criteria:

Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments (Nasreddine et al., 2005);
Current participation in another research study;
Unavailable or unable to participate in planned dates for the HST-IIP sessions;
Expected hospitalization during the study period, including second and third trimester pregnancy at screening;
Expected incarceration during the study period;
Previous experience with mindfulness or other mind-body practices, defined as more than 10 minutes of practice per day, more than 5 days a week for the past 6 months; participation in an 8-week mindfulness group program in the last 2 years; or participation in a meditation retreat longer than 1 day in the past 2 years;
Inability to successfully complete in-person study sessions with EEG, EKG, respiration rate, and skin conductance response measurement as determined by the principal investigator;
Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria):
Active psychosis defined by a PSY-S-CAT score > 60 (from the CAT-MH assessment) will trigger the requirement of a clinical assessment prior to participation in the program (Achtyes et al., 2015)
Bipolar I disorder history or severe level of mania on CAT-MH (score >70) (Achtyes et al., 2015): In addition, current use of mood stabilizing medication for bipolar disorder.
Severe depression, indicated by CAT-DI > 75 (Achtyes et al., 2015; Gibbons et al., 2012)
Acute homicidality with plan and/or intent;
Acute suicidality or hospitalization for suicide attempt or self-harm within three months of the enrollment period;
Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or
Moderate or severe Substance Use Disorder. In addition, reported use of illicit drugs (i.e., cocaine, methamphetamine) OR non-prescribed controlled medications (opioids, stimulants, or benzodiazepines) in the past 3 months.

Sites / Locations

Cambridge Health Alliance Center for Mindfulness and Compassion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Heart-Smile Training Intensive Introductory Program (HST-IIP) Group

Waitlist Control Group

Arm Description

The HST-IIP group will complete the Heart-Smile Training Intensive Introductory Program during weeks 1 through 4 of the study.

The waitlist arm will not complete any intervention during their time in the study. They will continue their treatment as usual without any change in their therapy session or medication. After their post study visits are complete, they will have the opportunity to participate in Mindfulness-Based Intervention courses through the Cambridge Health Alliance Center for Mindfulness and Compassion.

Outcomes

Primary Outcome Measures

Change from Baseline heartbeat evoked potential (HEP) at 4 weeks

HEP has been used as a marker to assess interoceptive awareness between depressed individuals and normal control (MacKinnon et al., 2013). The second primary outcome is to evaluate the effects of HST-IIP on EEG heartbeat evoked potentials (HEP) and the correlation between the pre- versus post-intervention changes in HEP amplitude and changes in depression severity.

Secondary Outcome Measures

Change from Baseline Gamma Band Frequency at 4 weeks

Gamma band frequency (>35 Hz) has been demonstrated as an objective measure of meditation experience across techniques (Braboszcz et al., 2017) and is associated with positive emotionality and enhanced affective regulation. Therefore, the primary outcome measure is an EEG measure of amplitude (power) in the gamma frequency band (>35 Hz), during both resting and compassionate state induction, from baseline to post-intervention.

Change from Baseline Depression (CAT-DI) at 4 weeks

Computerized Adaptive Test-Depression Inventory (CAT-DI) will be used to assess the depression severity (Achtyes et al., 2015; Gibbons et al., 2012).

Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 4 weeks.

HRV is an autonomic biomarker of cardiovagal modulation. HRV will be calculated from EKG which will be recorded with EEG co-synchronously.

Full Information

NCT ID

NCT05564533

First Posted

September 26, 2022

Last Updated

September 29, 2022

Sponsor

Cambridge Health Alliance

Collaborators

Spaulding Rehabilitation Hospital, Korea Advanced Institute of Science and Technology

1. Study Identification

Unique Protocol Identification Number

NCT05564533

Brief Title

Heart-Smile Training Intensive Introduction Program

Acronym

HST-IIP

Official Title

Neurophysiological Effects of Interoceptive Compassion Training

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2022 (Anticipated)

Primary Completion Date

April 7, 2023 (Anticipated)

Study Completion Date

November 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cambridge Health Alliance

Collaborators

Spaulding Rehabilitation Hospital, Korea Advanced Institute of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Heart-Smile Training (HST) is a compassion and loving-kindness-based intensive introduction program consisting of a 3-day retreat, 4-weeks of weekly 2 hour meetings, and a 1-day final retreat. This study is a randomized controlled trial study to evaluate the effectiveness of Heart-Smile Training as compared to the passive control group on measures of neural, physiological, and clinically-relevant outcomes among individuals with symptoms of depression. Participants will be randomized to either the HST group or a waitlist control group. Both groups will complete assessments before and after HST including electroencephalography (EEG), electrocardiogram (EKG), electrodermal activity tests, and self-report surveys. All study activities except surveys will be conducted in person.

Detailed Description

This will be a randomized controlled trial with two arms: Heart-Smile Training Intensive Introduction Program (HST-IIP) vs. a waitlist control group. These two arms will be compared on measures of neural, physiological, and clinically-relevant outcomes. The investigators will enroll up to 50 adult volunteers from the general population from the ages of 18 to 60 with depression, with Computerized Adaptive Test- Depression Inventory (CAT-DI) scores from 35-75. Volunteers interested in the study will be consented and screened for their eligibility. Eligible participants will be randomized to join either the HST-IIP arm or a waitlist control arm after completing all baseline assessments and the EEG session. Both the HST-IIP and waitlist arm will complete a baseline measurement session between study weeks -3 to 0, before starting any group sessions. Prior to completing the baseline measurement section, they will be randomized to either HST-IIP or the waitlist arm. Participants enrolled in the HST-IIP arm will join the intervention group between week 1 to 4. The waitlist arm will not join any program between week 1 to 4. They will continue their treatment as usual without any change in their therapy session or medication. Both arms will complete weekly survey measures for 4 weeks. Both arms will then complete a post measurement session during study weeks 5 to 7. At both baseline and post-intervention measurement sessions, all participants will complete in-person study tasks and remote surveys. In-person study visits will include neurophysiological measures; EEG, EKG, skin conductance, and respiration rate measures and will take place at the Spaulding Rehabilitation Hospital/Mass General Brigham in Charlestown, MA. Remote self-report surveys will be completed by participants during baseline and post-measurement either at home through a link secure to the Cambridge Health Alliance (CHA) REDCap database sent via email or using an electronic device at the CHA Center for Mindfulness and Compassion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Heart-Smile Training Intensive Introductory Program (HST-IIP) Group

Arm Type

Experimental

Arm Description

The HST-IIP group will complete the Heart-Smile Training Intensive Introductory Program during weeks 1 through 4 of the study.

Arm Title

Waitlist Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Heart-Smile Training Intensive Introduction Program (HST-IIP)

Intervention Description

Heart-Smile Training (HST) is an interoceptive compassion program designed to develop the qualities of compassion, empathy, and kindness for oneself and others with a focus on interoceptive awareness. It is unique from other compassion trainings in its focus on 1) embodiment of warmth and tenderness of compassionate feeling with a compassionate body scan meditation, 2) development of an "authentic presence," characterized by a warm feeling of loosened attachment to ego-based self, and 3) cultivation of joy triggered by genuine smile to oneself. HST-IIP is a 3-day/4-week/1-day interoceptive compassion program that shares the same core elements and practices as HST 3-day intensive program. Unlike HST, the format of the HST-IIP has an extended duration to develop self-regulation through the cultivation of emotional and behavioral regulation.

Primary Outcome Measure Information:

Title

Change from Baseline heartbeat evoked potential (HEP) at 4 weeks

Description

Time Frame

Up to 11 weeks

Secondary Outcome Measure Information:

Title

Change from Baseline Gamma Band Frequency at 4 weeks

Description

Time Frame

Up to 11 weeks

Title

Change from Baseline Depression (CAT-DI) at 4 weeks

Description

Computerized Adaptive Test-Depression Inventory (CAT-DI) will be used to assess the depression severity (Achtyes et al., 2015; Gibbons et al., 2012).

Time Frame

Up to 11 weeks

Title

Change from Baseline High Frequency Heart Rate Variability (HF-HRV) at 4 weeks.

Description

HRV is an autonomic biomarker of cardiovagal modulation. HRV will be calculated from EKG which will be recorded with EEG co-synchronously.

Time Frame

Up to 11 weeks

Other Pre-specified Outcome Measures:

Title

Change from Baseline Skin Conductance Response at 4 weeks

Description

Skin conductance is a psychophysiological measure of sympathetic nervous system activity. Skin conductance response (SCR) will be measured with EEG co-synchronously.

Time Frame

Up to 11 weeks

Title

Change from Baseline Clinically Relevant Psychological Data at 4 weeks

Description

Clinically Relevant Psychological outcome measures include assessments of mindfulness, self-compassion, interoceptive awareness, interoceptive appreciation, difficulties in emotional regulation, quality of life, gratitude, anxiety, depression, stress, purpose in life, and social connectedness.

Time Frame

Up to 11 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sufficient English fluency to understand procedures and questionnaires Ability to provide informed consent Mild to moderately severe depression (CAT-DI score 35-75) (Achtyes et al., 2015; Gibbons et al., 2012) Exclusion Criteria: Cognitive inability as demonstrated by Montreal Cognitive Assessment (MOCA) <24 OR the inability to complete consent quiz and baseline assessments (Nasreddine et al., 2005); Current participation in another research study; Unavailable or unable to participate in planned dates for the HST-IIP sessions; Expected hospitalization during the study period, including second and third trimester pregnancy at screening; Expected incarceration during the study period; Previous experience with mindfulness or other mind-body practices, defined as more than 10 minutes of practice per day, more than 5 days a week for the past 6 months; participation in an 8-week mindfulness group program in the last 2 years; or participation in a meditation retreat longer than 1 day in the past 2 years; Inability to successfully complete in-person study sessions with EEG, EKG, respiration rate, and skin conductance response measurement as determined by the principal investigator; Inability to participate safely in the study intervention and without disrupting the group (in the opinion of principal investigator OR meeting any of the following criteria): Active psychosis defined by a PSY-S-CAT score > 60 (from the CAT-MH assessment) will trigger the requirement of a clinical assessment prior to participation in the program (Achtyes et al., 2015) Bipolar I disorder history or severe level of mania on CAT-MH (score >70) (Achtyes et al., 2015): In addition, current use of mood stabilizing medication for bipolar disorder. Severe depression, indicated by CAT-DI > 75 (Achtyes et al., 2015; Gibbons et al., 2012) Acute homicidality with plan and/or intent; Acute suicidality or hospitalization for suicide attempt or self-harm within three months of the enrollment period; Severe Borderline Personality Disorder or other severe personality disorder that may lead to disruptions within the group; and/or Moderate or severe Substance Use Disorder. In addition, reported use of illicit drugs (i.e., cocaine, methamphetamine) OR non-prescribed controlled medications (opioids, stimulants, or benzodiazepines) in the past 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Frances V Marin, BS

Phone

617-643-8770

fmarin@challiance.org

First Name & Middle Initial & Last Name or Official Title & Degree

Alexandra Comeau, MA

Phone

617-806-8735

acomeau@challiance.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zev Schuman-Olivier, MD

Organizational Affiliation

Cambridge Health Alliance Center for Mindfulness and Compassion

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cambridge Health Alliance Center for Mindfulness and Compassion

City

Somerville

State/Province

Massachusetts

ZIP/Postal Code

02143

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26030317

Citation

Achtyes ED, Halstead S, Smart L, Moore T, Frank E, Kupfer DJ, Gibbons R. Validation of Computerized Adaptive Testing in an Outpatient Nonacademic Setting: The VOCATIONS Trial. Psychiatr Serv. 2015 Oct;66(10):1091-6. doi: 10.1176/appi.ps.201400390. Epub 2015 Jun 1.

Results Reference

background

PubMed Identifier

28118405

Citation

Braboszcz C, Cahn BR, Levy J, Fernandez M, Delorme A. Increased Gamma Brainwave Amplitude Compared to Control in Three Different Meditation Traditions. PLoS One. 2017 Jan 24;12(1):e0170647. doi: 10.1371/journal.pone.0170647. eCollection 2017.

Results Reference

background

PubMed Identifier

23117634

Citation

Gibbons RD, Weiss DJ, Pilkonis PA, Frank E, Moore T, Kim JB, Kupfer DJ. Development of a computerized adaptive test for depression. Arch Gen Psychiatry. 2012 Nov;69(11):1104-12. doi: 10.1001/archgenpsychiatry.2012.14. Erratum In: Arch Gen Psychiatry. 2013 Jan;70(1):30.

Results Reference

background

PubMed Identifier

23824262

Citation

MacKinnon S, Gevirtz R, McCraty R, Brown M. Utilizing heartbeat evoked potentials to identify cardiac regulation of vagal afferents during emotion and resonant breathing. Appl Psychophysiol Biofeedback. 2013 Dec;38(4):241-55. doi: 10.1007/s10484-013-9226-5.

Results Reference

background

PubMed Identifier

15817019

Citation

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991.

Results Reference

background

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Heart-Smile Training Intensive Introduction Program

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