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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02447744
• Collaborator: Mclean Hospital (Other)
• Enrollment: 43
• Location: 1
• Arms: 2
• Actual Duration (Months): 23.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Anxiety; PTSD; Trauma, Psychological	Behavioral: Mindfulness based intervention	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Jul 21, 2016
• Actual Study Completion Date: Jul 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness group This arm receives an 8-week mindfulness based behavioral intervention program.	Behavioral: 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.
Other: Waitlist control group This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts 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 exclusion criteria

• Prior history with the mindfulness based stress reduction program or other systematic meditation programs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Mclean Hospital

Investigators

• Principal Investigator: Sara Lazar, PhD, MGH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sara W Lazar, Associate Research Scientist, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT02447744
• Other Study ID Numbers: 2014P000295
• First Posted: May 19, 2015
• Last Update Posted: Mar 23, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by Sara W Lazar, Associate Research Scientist, Massachusetts General Hospital: depression; anxiety; childhood trauma; mindfulness
• Additional relevant MeSH terms: Depression; Psychological Trauma

Study Results

Participant Flow

Arm/Group Title	Mindfulness Group	Waitlist Control Group
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	21	22
COMPLETED	15	21
NOT COMPLETED	6	1

Baseline Characteristics

Arm/Group Title	Mindfulness Group	Waitlist Control Group	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	21	22	43
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	26.667	25.273	25.953
Sex: Female, Male (Count of Participants)
Female	17 81%	14 63.6%	31 72.1%
Male	4 19%	8 36.4%	12 27.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	2 9.5%	2 9.1%	4 9.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 19%	2 9.1%	6 14%
White	12 57.1%	16 72.7%	28 65.1%
More than one race	3 14.3%	1 4.5%	4 9.3%
Unknown or Not Reported	0 0%	1 4.5%	1 2.3%
Region of Enrollment (participants) [Number]
United States	21 100%	22 100%	43 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Subjects' Perceived Stress Level
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Group	Waitlist Control Group
Arm/Group Description	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.	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.
Measure Participants	19	17
Mean (Standard Error) [score on a scale]	-5.526 (1.566)	1.000 (1.437)

2. Secondary Outcome

Title	Changes of Mindfulness
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mindfulness Group	Waitlist Control Group
Arm/Group Description	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.	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.
Measure Participants	18	15
Mean (Standard Error) [score on a scale]	0.337 (0.149)	0.049 (0.126)

3. Post-Hoc Outcome

Title	Percent Changes of Right Hippocampal Grey Matter Density
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Mindfulness Group	Waitlist Control Group
Arm/Group Description	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.	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.
Measure Participants	21	21
Mean (Standard Error) [Percent change]	0.8137 (0.3143)	-0.9229 (0.2014)

Adverse Events

Time Frame	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.
Arm/Group Title	Mindfulness Group		Waitlist Control Group
Arm/Group Description	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.		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.
All Cause Mortality
	Mindfulness Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Serious Adverse Events
	Mindfulness Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Mindfulness Group		Waitlist Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.