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| Name | Class |
|---|---|
| Mclean Hospital | OTHER |
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Childhood trauma is remarkably prevalent, and it has long lasting impact on mental health and neural development. This trial aims to see whether the 8-week mindfulness based intervention can reduce stress related psychological symptoms for young adults with childhood maltreatment, and whether it can promote neural plasticity.
This study recruits young adults with childhood adversity; enrolled subjects either receive an 8-week mindfulness based intervention, or wait for 8 weeks before receiving the intervention. MRI and a battery of self report questionnaires will be administered before and after the intervention; subjects on the waiting list will undergo the same research procedures at the same time as subjects in the intervention group. Primary hypotheses include improved hippocampal plasticity, increased mindfulness and reduced stress and related psychological symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness group | Experimental | This arm receives an 8-week mindfulness based behavioral intervention program. |
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| Waitlist control group | Other | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness based intervention | Behavioral | The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Subjects' Perceived Stress Level | Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed. | After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Mindfulness | Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Lazar, PhD | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31749731 | Derived | Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness Group | This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| FG001 | Waitlist Control Group | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Group | This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Changes in Subjects' Perceived Stress Level | Changes in the Perceived Stress Scale scores (post- intervention scores minus pre- intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The Perceived Stress Scale is a 10 item scale (each responded with Likert scale 0-4), the scale score is the sum of all items, thus the full range of PSS scores is 0-40, with higher scores means worse stress. A reduction in PSS scores (i.e., the change scores being negative) indicates subjects have improved after the intervention by becoming less stressed. | Posted | Mean | Standard Error | score on a scale | After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. |
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Adverse event data were collected between the period of time when subjects are enrolled in the study and when subjects complete the post-intervention research procedures, or till subjects voluntarily drop out of the study before the completion of intervention and research procedures. The time frame is up to 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness Group | This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sara Lazar | MGH | 617-724-7108 | slazar@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| D000067073 | Psychological Trauma |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
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| After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. |
| Waitlist Control Group |
This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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This arm receives an 8-week mindfulness based behavioral intervention program. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
| OG001 | Waitlist Control Group | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. |
|
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| Secondary | Changes of Mindfulness | Changes in the mindfulness level as measured by the Mindful Attention Awareness Scale (post-intervention scores minus pre-intervention scores). Relevant time points used in the calculation include baseline scores at enrollment, and post-intervention/waiting period scores after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period scores minus baseline scores for each individual subject. The MAAS is a 15-item scale each responded with Likert scale 1-6; the MAAS score calculated as the mean of all items, thus the full range of the score is 1-6, with higher scores meaning more mindful. An increase in MAAS score (i.e., a positive score change )means the subject has improved after the intervention by becoming more mindful. | Posted | Mean | Standard Error | score on a scale | After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. |
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| Post-Hoc | Percent Changes of Right Hippocampal Grey Matter Density | Gray matter density of the right hippocampus is calculated from anatomical MRI data with the SPM software. Percent changes of gray matter density is calculated for each subject. Relevant time points used in the calculation include baseline values at enrollment, and post-intervention/waiting period values after 2 months of intervention or waiting period. Calculations of the change entail post-intervention/waiting period values minus baseline values, then divided by the baseline values to obtain the percent change measure. | Subjects who completed both baseline and post-intervention/waiting period were entered into analyses. 6 Subjects from the waiting list control group completed a third MRI after completing the mindfulness intervention. | Posted | Mean | Standard Error | Percent change | 2 months |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | Waitlist Control Group | This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period. Mindfulness based intervention: The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress. | 0 | 22 | 0 | 22 | 0 | 22 |
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| D000068099 |
| Trauma and Stressor Related Disorders |