Generalized Anxiety DisorderNCT00961493
RCT of an Acceptance-based Behavior Therapy for GAD
A study testing Acceptance based behavioral therapy and Applied relaxation in people with Generalized Anxiety Disorder, run by University of Massachusetts, Boston at 1 site in United States.
Trial summary
The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Acceptance based behavioral therapy and Applied relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Feb 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- principal diagnosis of GAD
- at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
- willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
- fluent in English
- 18 years or older
Who cannot join
- bipolar disorder
- psychotic disorders
- substance dependence
- active suicidal intent
- if anxious symptomatology is due to a medical/physical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02215
About this study
Official title: Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder
The purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Acceptance based behavioral therapy, Applied relaxation
- 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.
Acceptance based behavioral therapyBehavioural
16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions.
Applied relaxationBehavioural
16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Acceptance based behavioral therapy |
| 2 | Active comparator | Not described Receives: Behavioral: Applied relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
Measured: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Hamilton Anxiety Rating Scale
Measured: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Penn State Worry Questionnaire
Measured: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Secondary outcomes (2)
Beck Depression Inventory - II
Measured: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Quality of Life Inventory
Measured: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- 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
- Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Boston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Lizabeth Roemer, University of Massachusetts, Boston
- Investigators
- Lizabeth Roemer, Ph.D., Principal investigator, University of Massachusetts, Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961493
- Sponsor's protocol ID
- R01MH074589
- Other IDs
- R01MH074589, NIH MH074589, DSIR 83-ATAS2
- Status last verified
- Jun 2013
- First submitted
- 18 Aug 2009
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of an Acceptance-based Behavior Therapy for Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT00961493
- Acronym / sponsor ID
- R01MH074589
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of Massachusetts, BostonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Aug 2009 (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 purpose of this study is to determine whether acceptance-based behavior therapy for GAD results in greater symptom reduction and increased quality of life than applied relaxation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Acceptance based behavioral therapy |
| 2 | Active comparator | Behavioral: Applied relaxation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- principal diagnosis of GAD
- at least moderate (4 on a scale from 0 to 8) on the ADIS Severity Scale for GAD symptoms
- willing to maintain current psychotropic medication levels (and have been stabilized on any current medications for at least three months) and refrain from other psychosocial treatments for anxiety or mood problems during the course of therapy
- fluent in English
- 18 years or older
Key exclusion criteria (5 listed)
- bipolar disorder
- psychotic disorders
- substance dependence
- active suicidal intent
- if anxious symptomatology is due to a medical/physical condition
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 therapy16 individual psychotherapy sessions focused on psychoeducation about anxiety, anxious responding, the function of emotions, mindfulness, and problems with efforts to constrict one's emotional experience; training in mindfulness skills; practice applying mindfulness skills in daily life, including acceptance of, rather than efforts to control, internal experience; and identification of values in areas of life and practice engaging in chosen actions. | Behavioural | 1 |
| Applied relaxation16 sessions of individual psychotherapy focused on psychoeducation about anxiety and anxious responding; training in multiple forms of relaxation; early cue detection; and practice applying relaxation in daily life. | Behavioural | 2 |
Primary outcome
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD
Time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Hamilton Anxiety Rating Scale
Time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Penn State Worry Questionnaire
Time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
2 secondary outcomes
Beck Depression Inventory - II
Time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
Quality of Life Inventory
Time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up
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 19 Jun 2013.
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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, Ph.D. principal investigator
University of Massachusetts, Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance based behavioral therapy and Applied relaxation in people with 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 5 inclusion and 5 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 19 Jun 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.
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?
Anxiety Disorders Interview Schedule for DSM-IV, Clinician Severity Rating of GAD (time frame: pre-treatment, post-treatment, and 6-, 12-, and 24-month follow-up). 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?
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 19 Jun 2013.