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.

Study Overview

• Status: Completed
• Conditions: Depression; PTSD; Anxiety; Trauma, Psychological
• Intervention / Treatment: Behavioral: Mindfulness based intervention

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness group; This arm receives an 8-week mindfulness based behavioral intervention program.	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.
Other: Waitlist control group; This arm waits while the mindfulness group receives their intervention, and then receives the mindfulness based intervention after their waiting period.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Mclean Hospital
• Investigators: Principal Investigator: Sara Lazar, PhD, MGH

Publications and helpful links

General Publications

• Joss D, Khan A, Lazar SW, Teicher MH. Effects of a Mindfulness-Based Intervention on Self-Compassion and Psychological Health Among Young Adults With a History of Childhood Maltreatment. Front Psychol. 2019 Oct 23;10:2373. doi: 10.3389/fpsyg.2019.02373. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 21, 2016
• Study Completion (Actual): July 21, 2016

Study Registration Dates

• First Submitted: December 2, 2014
• First Submitted That Met QC Criteria: May 14, 2015
• First Posted (Estimate): May 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: depression; anxiety; mindfulness; childhood trauma
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Psychological Trauma
• Other Study ID Numbers: 2014P000295