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Completed

NCT Number: NCT01128309

Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Stress reduction intervention

Behavioral

eight week group program, plus daily homework practice

Active Control Intervention

Behavioral

weekly group meetings for eight weeks, plus daily homework practice

Primary outcomes

  1. brain activation and structure as assessed by MRI

    Time frame: Day 1 (within two weeks before the intervention)

    BOLD functional MRI and structural MRI

  2. brain activation and structure as assessed by MRI

    Time frame: Day 2 (within two weeks after the intervention)

    BOLD functional MRI and structural MRI

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • European Commission

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 21, 2010
Registry last updated
May 7, 2012

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.

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