Anxiety DisordersPhase 1NCT00073632
Acceptance-Based Treatment for Generalized Anxiety Disorder
A Phase 1 study testing Acceptance Based Behavioral Therapy in people with Anxiety Disorders and Generalized Anxiety Disorder, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Generalized Anxiety Disorder
- What is being tested?
- Acceptance Based Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Aug 2006
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Generalized Anxiety Disorder (GAD)
- Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study
Who cannot join
- Bipolar disorder, psychotic disorder, or substance dependence
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders
Boston, Massachusetts
About this study
Official title: Developing a New Therapy for GAD: Acceptance-Based CBT
This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.
Read the detailed description
Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Being tested
- Acceptance Based Behavioral Therapy
- Medical subject headings
- Anxiety Disorders, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance Based Behavioral TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Severity Rating from ADIS for GAD
Measured: pre, post, 3 mo. f/u, 9 mo. f/u
Penn State Worry Questionnaire
Measured: pre-, post-, 3 mo. f/u, 9 mo. f/u
Depression Anxiety and Stress Scales, anxiety and stress subscales
Measured: pre-, post-, 3 mo. f/u, 9 mo. f/u
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2003 (estimated)
- Study startMay 2002
- Primary completionJul 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Lizabeth Roemer, PhD, Principal investigator, University of Massachusetts, BostonSusan M Orsillo, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00073632
- Sponsor's protocol ID
- R21MH063208
- Other IDs
- R21MH063208, DSIR AT-AS
- Status last verified
- Sep 2008
- First submitted
- 2 Dec 2003
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.
PubMed 17292696
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a New Therapy for GAD: Acceptance-Based CBT
- ClinicalTrials.gov ID
- NCT00073632
- Acronym / sponsor ID
- R21MH063208
- Conditions
- Anxiety Disorders, Generalized Anxiety Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2002
- Primary completion
- Jul 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 3 Dec 2003 (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.
This study will develop and implement an awareness- and acceptance-based for treatment of individuals with generalized anxiety disorder.
Detailed description
Participants in this study are recruited from intakes at the Center for Anxiety and Related Disorders at Boston University. Participants will be randomly assigned to receive either acceptance and mindfulness-based strategies plus cognitive behavioral therapy or no treatment for 16 weeks. The treatment will involve daily practice of mindfulness techniques to help draw attention to and accept various emotional states. Interviews, questionnaires, and depression and anxiety scales will be used to assess participants. Assessments will be conducted post-treatment and at 3- and 9-month follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Generalized Anxiety Disorder (GAD)
- Willing to maintain medication levels and refrain from any additional psychosocial treatment during the course of the study
Key exclusion criteria (1 listed)
- Bipolar disorder, psychotic disorder, or substance dependence
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 |
|---|---|---|
| Acceptance Based Behavioral Therapy | Behavioural | – |
Primary outcome
Clinician Severity Rating from ADIS for GAD
Time frame: pre, post, 3 mo. f/u, 9 mo. f/u
Penn State Worry Questionnaire
Time frame: pre-, post-, 3 mo. f/u, 9 mo. f/u
Depression Anxiety and Stress Scales, anxiety and stress subscales
Time frame: pre-, post-, 3 mo. f/u, 9 mo. f/u
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 6 Nov 2013.
- Background: PubMed 17292696Roemer L, Orsillo SM. An open trial of an acceptance-based behavior therapy for generalized anxiety disorder. Behav Ther. 2007 Mar;38(1):72-85. doi: 10.1016/j.beth.2006.04.004. Epub 2006 Oct 24.
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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.
Lizabeth Roemer, PhD principal investigator
University of Massachusetts, Boston
Susan M Orsillo, PhD principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acceptance Based Behavioral Therapy in people with Anxiety Disorders and Generalized Anxiety Disorder, run by University of Massachusetts, Boston 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 2 inclusion and 1 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 6 Nov 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinician Severity Rating from ADIS for GAD (time frame: pre, post, 3 mo. f/u, 9 mo. f/u). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00073632, which also lists 1 linked publication.
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 6 Nov 2013.