NCT01128309

Brief Summary

The aim of the study is to test whether Generalized Anxiety Disorder (GAD) patients that participate in a Stress Reduction Intervention show a brain activation pattern (assessed by MRI) indicative of improved emotion regulation compared to an active control intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

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

Study Start

First participant enrolled

May 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

May 19, 2010

Last Update Submit

May 4, 2012

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (2)

  • brain activation and structure as assessed by MRI

    BOLD functional MRI and structural MRI

    Day 1 (within two weeks before the intervention)

  • brain activation and structure as assessed by MRI

    BOLD functional MRI and structural MRI

    Day 2 (within two weeks after the intervention)

Study Arms (2)

Stress Reduction Intervention

EXPERIMENTAL

Stress Reduction Intervention

Behavioral: Stress Reduction Intervention

Active Control Condition

ACTIVE COMPARATOR
Behavioral: Active Control intervention

Interventions

Stress Reduction InterventionBEHAVIORAL

eight week group program, plus daily homework practice

Stress Reduction Intervention
Active Control interventionBEHAVIORAL

weekly group meetings for eight weeks, plus daily homework practice

Active Control Condition

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge

You may not qualify if:

  • metallic implants
  • left handed
  • epileptic seizures
  • head trauma
  • weight over 350 pounds
  • claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Sara W Lazar, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • Britta K Holzel, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 19, 2010

First Posted

May 21, 2010

Study Start

May 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

May 7, 2012

Record last verified: 2012-05

Locations

US(1)