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Clinical Trials/NCT02447744
NCT02447744
Completed
Not Applicable

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

Massachusetts General Hospital1 site in 1 country43 target enrollmentAugust 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Massachusetts General Hospital
Enrollment
43
Locations
1
Primary Endpoint
Changes in Subjects' Perceived Stress Level
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2014
End Date
July 21, 2016
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sara W Lazar

Associate Research Scientist

Massachusetts General Hospital

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.

Outcomes

Primary Outcomes

Changes in Subjects' Perceived Stress Level

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.

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 Outcomes

  • 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.)

Study Sites (1)

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