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Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02447744
Enrollment
43
Registered
2015-05-19
Start date
2014-08-01
Completion date
2016-07-21
Last updated
2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, PTSD, Trauma, Psychological

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

Mclean Hospital
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 35 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Changes in Subjects' Perceived Stress LevelAfter 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

MeasureTime frameDescription
Changes of MindfulnessAfter 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

ArmCount
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
Total43

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyData not collected b/c logistic reasons30
Overall StudyWithdrawal by Subject31

Baseline characteristics

CharacteristicMindfulness GroupTotalWaitlist Control Group
Age, Continuous26.667 years25.953 years25.273 years
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants4 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants6 Participants2 Participants
Race (NIH/OMB)
More than one race
3 Participants4 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants
Race (NIH/OMB)
White
12 Participants28 Participants16 Participants
Region of Enrollment
United States
21 participants43 participants22 participants
Sex: Female, Male
Female
17 Participants31 Participants14 Participants
Sex: Female, Male
Male
4 Participants12 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 22
other
Total, other adverse events
0 / 210 / 22
serious
Total, serious adverse events
0 / 210 / 22

Outcome results

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.

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.

ArmMeasureValue (MEAN)Dispersion
Mindfulness GroupChanges in Subjects' Perceived Stress Level-5.526 score on a scaleStandard Error 1.566
Waitlist Control GroupChanges in Subjects' Perceived Stress Level1.000 score on a scaleStandard Error 1.437
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.

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.

ArmMeasureValue (MEAN)Dispersion
Mindfulness GroupChanges of Mindfulness0.337 score on a scaleStandard Error 0.149
Waitlist Control GroupChanges of Mindfulness0.049 score on a scaleStandard Error 0.126
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.

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.

ArmMeasureValue (MEAN)Dispersion
Mindfulness GroupPercent Changes of Right Hippocampal Grey Matter Density0.8137 Percent changeStandard Error 0.3143
Waitlist Control GroupPercent Changes of Right Hippocampal Grey Matter Density-0.9229 Percent changeStandard Error 0.2014

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026