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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447744
• Other study ID #: 2014P000295
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Psychological Trauma
• PTSD
• Trauma, Psychological

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.