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Completed

NCT Number: NCT02447744

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

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.

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Key information

Age range

19 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Intervention

Behavioral

The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.

Primary outcomes

  1. 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

  1. Changes of Mindfulness

    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 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Mclean Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 19, 2015
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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