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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02447744
Other study ID # 2014P000295
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2014
Est. completion date July 21, 2016

Study information

Verified date March 2021
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date July 21, 2016
Est. primary completion date July 21, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 35 Years
Eligibility 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.

Study Design


Intervention

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.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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.
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 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.
After the 8-week intervention program compared to baseline measurement, or the same time as the intervention group for subjects on the waiting list.
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