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NCT01033851 · ClinicalTrials.gov registry record · Phase 4
Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects
A Phase 4 study of Generalized Anxiety Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 89
- Enrollment target
- 1
- Study location
NCT01033851: Completed Phase 4 study of Generalized Anxiety Disorder, sponsored by Massachusetts General Hospital.
NCT01033851 is a Phase 4 study of Generalized Anxiety Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 89 participants, below the 213-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01033851, a Phase 4 study of Generalized Anxiety Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 89 participants
- Enrollment target
- 1
- Study location
Study Summary
Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation and yoga, which is taught as part of the Mindfulness-based stress reduction (MBSR) course, an 8-week manualized mindfulness intervention. We hypothesize that the two approaches will reduce anxiety in individuals with GAD in different ways. We will measure changes in stress hormones associated with these changes.
Primary Outcome
The Hamilton Anxiety Scale (HAMA) was defined as the primary anxiety outcome variable. This scale has 14 items describing symptoms of anxiety, each answered on a 0-4 scale, with 0 for a single question generally representing no symptoms, and 4 representing severe levels of the symptom. The total score is calculated by adding all the items together, for a possible total score of 0 to 56.
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness Based Stress Reduction
- BEHAVIORAL Stress Management Education
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2008-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01033851 record still lists
NCT01033851 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 89 participants, a relatively small participant target, below the 213-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness Based Stress Reduction is the first listed.
NCT01033851 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01033851 about?
NCT01033851 is a clinical study titled "Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects". Current therapies for Generalized Anxiety Disorder (GAD) have limited effectiveness. This study measures the efficacy of two different approaches to reducing anxiety and stress. One approach uses education, nutrition, exercise, and time management training, and another uses mindfulness meditation an...
What is the current status of trial NCT01033851?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 89 participants. The study started on 2008-03. Estimated completion is 2013-02.
What conditions does trial NCT01033851 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder.
What interventions are being tested in trial NCT01033851?
The interventions under investigation include: Mindfulness Based Stress Reduction (BEHAVIORAL), Stress Management Education (BEHAVIORAL).
Who is sponsoring clinical trial NCT01033851?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01033851 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Generalized Anxiety Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01033851's enrollment target sits among peer trials
89 30th of 48 higher than 19 of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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