Generalized Anxiety DisorderNCT01128309
Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
A study testing Stress Reduction Intervention in people with Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Stress Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge
Who cannot join
- metallic implants
- left handed
- epileptic seizures
- head trauma
- weight over 350 pounds
- claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Stress Reduction Intervention, Active Control intervention
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Reduction InterventionBehavioural
eight week group program, plus daily homework practice
Active Control interventionBehavioural
weekly group meetings for eight weeks, plus daily homework practice
| Study group | Role | What they receive |
|---|---|---|
| Stress Reduction Intervention | Experimental | Stress Reduction Intervention Receives: Behavioral: Stress Reduction Intervention |
| Active Control Condition | Active comparator | Not described Receives: Behavioral: Active Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain activation and structure as assessed by MRI
BOLD functional MRI and structural MRI
Measured: Day 1 (within two weeks before the intervention)
brain activation and structure as assessed by MRI
BOLD functional MRI and structural MRI
Measured: Day 2 (within two weeks after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Principal investigator, Britta Holzel, Massachusetts General Hospital
- Investigators
- Sara W Lazar, PhD, Principal investigator, Massachusetts General HospitalBritta K Holzel, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128309
- Sponsor's protocol ID
- 2010P000947
- Other IDs
- 236975
- Status last verified
- May 2012
- First submitted
- 19 May 2010
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Reduction and Anxiety: Effects on the Function and Structure of the Brain
- ClinicalTrials.gov ID
- NCT01128309
- Acronym / sponsor ID
- 2010P000947
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- May 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Reduction Intervention | Experimental | Behavioral: Stress Reduction InterventionStress Reduction Intervention |
| Active Control Condition | Active comparator | Behavioral: Active Control intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- participation in the study 'Stress Reduction Techniques and Anxiety: Therapeutic and Neuroendocrine Effects" by Dr. Elizabeth Hoge
Key exclusion criteria (6 listed)
- metallic implants
- left handed
- epileptic seizures
- head trauma
- weight over 350 pounds
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress Reduction Interventioneight week group program, plus daily homework practice | Behavioural | Stress Reduction Intervention |
| Active Control interventionweekly group meetings for eight weeks, plus daily homework practice | Behavioural | Active Control Condition |
Primary outcome
brain activation and structure as assessed by MRI
Time frame: Day 1 (within two weeks before the intervention)
BOLD functional MRI and structural MRI
brain activation and structure as assessed by MRI
Time frame: Day 2 (within two weeks after the intervention)
BOLD functional MRI and structural MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara W Lazar, PhD principal investigator
Massachusetts General Hospital
Britta K Holzel, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Reduction Intervention in people with Generalized Anxiety Disorder, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain activation and structure as assessed by MRI (time frame: Day 1 (within two weeks before the intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2012.