Generalized Anxiety DisorderNCT00308724
Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
A study testing Cognitive Behavior Therapy and Telephone check-in in people with Generalized Anxiety Disorder, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in 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
- What is being tested?
- Cognitive Behavior Therapy and Telephone check-in
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Apr 2015
- 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
- Clinical diagnosis of Generalized Anxiety Disorder
Who cannot join
- Active suicidal intent
- Current psychosis
- Current bipolar disorder
- Substance abuse within past month
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Houston Center for Quality of Care and Utilization Studies
Houston, Texas, 77030
About this study
The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.
Read the detailed description
Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.
The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Behavior Therapy, Telephone check-in
- Keywords
- Generalized Anxiety Disorder, Geriatric
- 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.
Cognitive Behavior TherapyBehavioural
Also called CBT
8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period
Telephone check-inBehavioural
Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Cognitive Behavior Therapy Receives: Behavioral: Cognitive Behavior Therapy |
| 2 | Active comparator | Usual Care Receives: Behavioral: Telephone check-in |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Measured: Baseline and 3, 6, 9, 12 and 15 months
Secondary outcomes (7)
Functional and health status
Measured: Baseline and 3, 6, 9, 12 and 15 months
Quality of life inventory (QOLI)
Measured: Baseline and 3, 6, 9, 12 and 15 months
Satisfaction with CBT and general health care
Measured: Baseline and 3, 6, 9, 12 and 15 months
Service utilization
Measured: Baseline and 3, 6, 9, 12 and 15 months
Depression
Measured: Baseline and 3, 6, 9, 12 and 15 months
Sleep quality
Measured: Baseline and 3, 6, 9, 12 and 15 months
Use of alcohol and other substances
Measured: Baseline and 3, 6, 9, 12 and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2006 (estimated)
- Study startMar 2004
- Primary completionJan 2008
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston, Kelsey Research Foundation, Kelsey-Seybold Clinic, Michael E. DeBakey VA Medical Center
- Responsible party
- Principal investigator, Melinda Stanley, Baylor College of Medicine
- Investigators
- Melinda A. Stanley, Ph.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00308724
- Sponsor's protocol ID
- H15958
- Other IDs
- R01MH053932
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2006
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available.
PubMed 16325733Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available.
PubMed 16299425Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.
PubMed 12527544Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12.
PubMed 25497362Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7. doi: 10.1001/jama.2009.458.
PubMed 19351943
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Late-Life Generalized Anxiety Disorder (GAD) in Primary Care
- ClinicalTrials.gov ID
- NCT00308724
- Acronym / sponsor ID
- H15958
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH), The University of Texas Health Science Center, Houston, Kelsey Research Foundation, Kelsey-Seybold Clinic, Michael E. DeBakey VA Medical Center
- Study start
- Mar 2004
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 30 Mar 2006 (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 cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.
Detailed description
Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders among older adults. Anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. Because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. There is, however, limited evidence of the effectiveness of psychotropic medications. Given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts.
The treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (CBT) or usual care. Follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.
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: Cognitive Behavior TherapyCognitive Behavior Therapy |
| 2 | Active comparator | Behavioral: Telephone check-inUsual Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of Generalized Anxiety Disorder
Key exclusion criteria (5 listed)
- Active suicidal intent
- Current psychosis
- Current bipolar disorder
- Substance abuse within past month
- Cognitive impairment
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 Behavior TherapyAlso: CBT8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period | Behavioural | 1 |
| Telephone check-inBiweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition | Behavioural | 2 |
Primary outcome
Anxiety
Time frame: Baseline and 3, 6, 9, 12 and 15 months
7 secondary outcomes
Functional and health status
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Quality of life inventory (QOLI)
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Satisfaction with CBT and general health care
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Service utilization
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Depression
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Sleep quality
Time frame: Baseline and 3, 6, 9, 12 and 15 months
Use of alcohol and other substances
Time frame: Baseline and 3, 6, 9, 12 and 15 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 22 Mar 2024.
- Background: PubMed 16325733Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available.
- Background: PubMed 16299425Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available.
- Background: PubMed 12527544Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.
- Derived from this study: PubMed 25497362Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12.
- Derived from this study: PubMed 19351943Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7. doi: 10.1001/jama.2009.458.
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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.
Melinda A. Stanley, Ph.D. principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy and Telephone check-in in people with Generalized Anxiety Disorder, run by Baylor College of Medicine 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 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 22 Mar 2024. 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 (time frame: Baseline and 3, 6, 9, 12 and 15 months). 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 NCT00308724, which also lists 5 linked publications.
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 22 Mar 2024.