Anxiety, Depression, PTSD, Trauma, Psychological
Conditions
Keywords
depression, anxiety, childhood trauma, mindfulness
Brief summary
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.
Detailed description
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.
Interventions
The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Sponsors
Study design
Eligibility
Inclusion criteria
* Experience of childhood maltreatment * With current age between 19 to 35 years old * With current symptoms of depression or anxiety or PTSD or significant general stress.
Exclusion criteria
* History of psychiatric disorders with psychotic features * Suicidal attempts during the past six months * Neurological disorders * And common MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Subjects' Perceived Stress Level | After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of Mindfulness | After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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. | 22 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data not collected b/c logistic reasons | 3 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Mindfulness Group | Total | Waitlist Control Group |
|---|---|---|---|
| Age, Continuous | 26.667 years | 25.953 years | 25.273 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 28 Participants | 16 Participants |
| Region of Enrollment United States | 21 participants | 43 participants | 22 participants |
| Sex: Female, Male Female | 17 Participants | 31 Participants | 14 Participants |
| Sex: Female, Male Male | 4 Participants | 12 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 0 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
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.
Time frame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Group | Changes in Subjects' Perceived Stress Level | -5.526 score on a scale | Standard Error 1.566 |
| Waitlist Control Group | Changes in Subjects' Perceived Stress Level | 1.000 score on a scale | Standard Error 1.437 |
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.
Time frame: After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Group | Changes of Mindfulness | 0.337 score on a scale | Standard Error 0.149 |
| Waitlist Control Group | Changes of Mindfulness | 0.049 score on a scale | Standard Error 0.126 |
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.
Time frame: 2 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Group | Percent Changes of Right Hippocampal Grey Matter Density | 0.8137 Percent change | Standard Error 0.3143 |
| Waitlist Control Group | Percent Changes of Right Hippocampal Grey Matter Density | -0.9229 Percent change | Standard Error 0.2014 |