Skip to main content
OpenTrials
Completed

NCT Number: NCT02816502

Hippocampal Plasticity of Young Adults With Childhood Adversity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stress Management Skill Building Program A

Behavioral

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.

Stress Management Skill Building Program B

Behavioral

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.

Primary outcomes

  1. Changes in hippocampal subfield gray matter density measured with high resolution structural MRI at 3T

    Time frame: before and after the 8-week intervention

Secondary outcomes

  1. Changes in stress level measured by the Perceived Stress Scale (PSS)

    Time frame: before and after the 8-week intervention

  2. Changes in severity of depression symptom measured by Beck Depression Inventory (BDI)

    Time frame: before and after the 8-week intervention

  3. Changes in severity of anxiety symptom measured by State-Trait Anxiety Inventory (STAI)

    Time frame: before and after the 8-week intervention

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Jun 28, 2016
Registry last updated
Mar 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.