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

NCT02447744 | Completed Results

• 1 other identifier: 2014P000295
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; PTSD; Trauma, Psychological

Keywords

depression; anxiety; childhood trauma; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Mindfulness group

EXPERIMENTAL

This arm receives an 8-week mindfulness based behavioral intervention program.

Behavioral: Mindfulness based intervention

Waitlist control group

OTHER

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

Interventions

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.

Mindfulness group; Waitlist control group

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• History of psychiatric disorders with psychotic features
• Suicidal attempts during the past six months
• Neurological disorders
• Prior history with the mindfulness based stress reduction program or other systematic meditation programs.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Mclean Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 31749731 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Trauma

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Results Point of Contact

• Title: Dr. Sara Lazar
• Organization: MGH

slazar@mgh.harvard.edu

617-724-7108

Study Officials

• Sara Lazar, PhD

  MGH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Research Scientist

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: May 19, 2015
• Study Start: August 1, 2014
• Primary Completion: July 21, 2016
• Study Completion: July 21, 2016
• Last Updated: March 23, 2021
• Results First Posted: March 23, 2021

Record last verified: 2021-03

Locations

US (1)