NCT02816502

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

June 15, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2020

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

June 16, 2016

Last Update Submit

March 23, 2021

Conditions

DepressionAnxiety

Keywords

childhoodadversity

Outcome Measures

Primary Outcomes (1)

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

    before and after the 8-week intervention

Secondary Outcomes (3)

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

    before and after the 8-week intervention

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

    before and after the 8-week intervention

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

    before and after the 8-week intervention

Study Arms (2)

Stress Management Skill Building Program A

EXPERIMENTAL

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

Stress Management Skill Building Program B

ACTIVE COMPARATOR

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

Interventions

Stress Management Skill Building Program ABEHAVIORAL

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 A
Stress Management Skill Building Program BBEHAVIORAL

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

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Diane Joss, PhD

    Mclean Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Neuroscientist

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 28, 2016

Study Start

June 15, 2017

Primary Completion

December 1, 2018

Study Completion

July 7, 2020

Last Updated

March 25, 2021

Record last verified: 2021-03

Locations

US(1)