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

Not Applicable

Completed

• Conditions: Anxiety; PTSD; Depression; Trauma, Psychological
• Interventions: Behavioral: Mindfulness based intervention

• Registration Number: NCT02447744
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2014-08-01
• Study First Submitted: 2014-12-02
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2016-07-21
• Study Completion: 2016-07-21
• Results First Submitted: 2019-02-13
• Status Verified: 2021-03
• Results First Submitted QC: 2021-03-22
• Last Update Submitted: 2021-03-22
• Results First Posted: 2021-03-23
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waitlist control group	Mindfulness based intervention	This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.
Mindfulness group	Mindfulness based intervention	This arm receives an 8-week mindfulness based behavioral intervention program.

Primary Outcome Measures

Name	Time	Method
Changes in Subjects' Perceived Stress Level	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 Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States