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

Primary Purpose

Depression, Anxiety, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness based intervention
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring depression, anxiety, childhood trauma, mindfulness

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Mindfulness group

Waitlist control group

Arm Description

This arm receives an 8-week mindfulness based behavioral intervention program.

This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 2, 2014
Last Updated
March 22, 2021
Sponsor
Massachusetts General Hospital
Collaborators
Mclean Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02447744
Brief Title
Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
Official Title
Neural Changes Associated With a Mindfulness-based Intervention for Young Adults With Childhood Maltreatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (Actual)
Primary Completion Date
July 21, 2016 (Actual)
Study Completion Date
July 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Mclean Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, PTSD, Trauma, Psychological
Keywords
depression, anxiety, childhood trauma, mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness group
Arm Type
Experimental
Arm Description
This arm receives an 8-week mindfulness based behavioral intervention program.
Arm Title
Waitlist control group
Arm Type
Other
Arm Description
This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based intervention
Intervention Description
The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
Primary Outcome Measure Information:
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.
Secondary Outcome Measure Information:
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Lazar, PhD
Organizational Affiliation
MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31749731
Citation
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.
Results Reference
derived

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

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