Generalized Anxiety DisorderNCT00938093
Treatment of Late-life Anxiety in Primary Care Settings
A study testing Cognitive behavioral therapy in people with Generalized Anxiety Disorder and Panic Disorder, run by Wake Forest University Health Sciences.
Trial summary
The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Generalized Anxiety Disorder, Panic Disorder, Anxiety Disorder Not Otherwise Specified
- What is being tested?
- Cognitive behavioral therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Feb 2009
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 60 years
- a DSM-IV diagnosis of GAD
- able to read English.
Who cannot join
- current psychotherapy
- a DSM-IV diagnosis of alcohol or substance abuse
- a diagnosis of dementia or global cognitive impairment operationalized as a score of < 24 of the Mini-Mental Status Examination
- psychotic symptoms
- active suicidal ideation
About this study
The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.
- Being tested
- Cognitive behavioral therapy, Enhanced usual care
- Medical subject headings
- Generalized Anxiety Disorder, Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.
Enhanced usual careBehavioural
Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy | Active comparator | cognitive-behavioral therapy Receives: Behavioral: Cognitive behavioral therapy |
| Enhanced usual care | Placebo comparator | enhanced usual care Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSWQ-A
Measured: 4 months
HAM-A
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startMar 2006
- Primary completionFeb 2009
- Study completionFeb 2009
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 Wake Forest University Health SciencesThe 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Gretchen Brenes, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938093
- Sponsor's protocol ID
- MH65281
- Other IDs
- MH65281
- Status last verified
- Aug 2018
- First submitted
- 10 Jul 2009
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Late-life Anxiety in Primary Care Settings
- ClinicalTrials.gov ID
- NCT00938093
- Acronym / sponsor ID
- MH65281
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 13 Jul 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 research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy | Active comparator | Behavioral: Cognitive behavioral therapycognitive-behavioral therapy |
| Enhanced usual care | Placebo comparator | Behavioral: Enhanced usual careenhanced usual care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥ 60 years
- a DSM-IV diagnosis of GAD
- able to read English.
Key exclusion criteria (5 listed)
- current psychotherapy
- a DSM-IV diagnosis of alcohol or substance abuse
- a diagnosis of dementia or global cognitive impairment operationalized as a score of < 24 of the Mini-Mental Status Examination
- psychotic symptoms
- active suicidal ideation
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 |
|---|---|---|
| Cognitive behavioral therapyParticipants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety. | Behavioural | Cognitive-behavioral therapy |
| Enhanced usual careParticipants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician. | Behavioural | Enhanced usual care |
Primary outcome
PSWQ-A
Time frame: 4 months
HAM-A
Time frame: 4 months
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 13 Aug 2018.
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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.
Gretchen Brenes, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy in people with Generalized Anxiety Disorder and Panic Disorder, run by Wake Forest University Health Sciences.
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 3 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 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
PSWQ-A (time frame: 4 months). 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 13 Aug 2018.