Hippocampal Plasticity of Young Adults With Childhood Adversity

March 23, 2021 updated by: Diane Yan, Mclean Hospital
This study investigates the clinical and neural effects of stress management skill building programs for young adults with childhood adversity. The investigators will recruit a total of 60 young adults (21-35 years old) who will be randomized into two different stress management skill building programs, both of which are 8 weeks long. MRI and psychological assessments will be acquired from all subjects before and after the intervention programs in order to investigate changes in clinical symptoms (such as depression, anxiety and stress) and hippocampus structure and function as well as other neural changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • McLean Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • having childhood adversity
  • no history of psychiatric disorders of psychotic features or neurological disorders
  • verified age between 21-35 years old;
  • no suicidal attempts during the past six months;
  • being determined by the clinician to have the capability to comply with the program requirements and not detrimental to other participants in the group;
  • passing MRI eligibility criteria.
  • provided written informed consent to participate in this study;
  • committed to meeting the requirement of refraining from using marijuana or illicit drugs.

Exclusion Criteria:

  • psychosis
  • active suicidal attempts during the past 6 months
  • psychoactive substance abuse
  • MRI exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stress Management Skill Building Program A
An eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week.
Behavioral: Stress Management Skill Building Program A
Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
Active Comparator: Stress Management Skill Building Program B
An eight week skill building group in which subjects meet with the teacher and other students in the group once a week, and complete homework and practice log during the week.
Behavioral: Stress Management Skill Building Program B
Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T
Time Frame: before and after the 8-week intervention
before and after the 8-week intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in stress level measured by the Perceived Stress Scale (PSS)
Time Frame: before and after the 8-week intervention
before and after the 8-week intervention
Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)
Time Frame: before and after the 8-week intervention
before and after the 8-week intervention
Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)
Time Frame: before and after the 8-week intervention
before and after the 8-week intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mclean Hospital

Collaborators

Massachusetts General Hospital

Investigators

  • Principal Investigator: Diane Joss, PhD, McLean Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

July 7, 2020

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016P000335

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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