Generalized Anxiety DisorderNCT00765219
Cognitive Behavior Treatment of Older Adults With Generalized Anxiety Disorder in Primary Care
A study testing CBT 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 treatment (CBT) can be delivered effectively by providers of different expertise levels 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?
- CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 222 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to 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
- Age 60 and older
- Principal or Co-principal GAD diagnosis
- Patient at participating clinic
Who cannot join
- Active suicidal intent
- Current psychosis or bipolar disorder
- Substance abuse within the past month
- Cognitive impairment according to a Mini Cog screener score of 3 or lower
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
Official title: Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value
The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be delivered effectively by providers of different expertise levels 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 in later life. Given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts.
The treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (CBT) with an Anxiety Clinic Specialist (ACS) or Counselor or to Usual Care (UC). All participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. During the first 12 weeks, those assigned to CBT will also complete 10-12 weekly sessions, either in person or over the telephone. During the second 12 weeks, CBT patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. During the treatment phase, UC participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers.
At 6 months, all participants will complete a telephone assessment. CBT patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. UC participants will be offered the option to receive brief CBT after completion of the 6 month telephone assessment. Those who choose to participate in CBT will complete telephone assessments at 9 and 12 months.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- CBT, Usual Care
- 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.
CBTBehavioural
Also called Cognitive Behavior Treatment, Cognitive Behavior Therapy
10-12 weekly sessions of CBT in person or over the telephone.
Usual CareOther
Also called Treatment as Usual
Treatment as usual provided by participants' physician(s)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | CBT with ACS Receives: Behavioral: CBT |
| 2 | Experimental | CBT with Counselor Receives: Behavioral: CBT |
| 3 | Active comparator | Usual Care Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Measured: 18 months
Secondary outcomes (9)
Depression
Measured: 18 months
Sleep quality
Measured: 18 months
Use of alcohol
Measured: 18 months
Functional and health status
Measured: 18 months
Quality of life
Measured: 18 months
Pain
Measured: 18 months
Satisfaction with CBT and general health care
Measured: 18 months
Service utilization
Measured: 18 months
Use of psychotropic medications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2013
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Participant
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Melinda Stanley, Baylor College of Medicine
- Investigators
- Melinda A. Stanley, PhD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765219
- Sponsor's protocol ID
- H23798
- Other IDs
- R01MH053932-10A1
- Status last verified
- Jul 2015
- First submitted
- 1 Oct 2008
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Freshour JS, Amspoker AB, Yi M, Kunik ME, Wilson N, Kraus-Schuman C, Cully JA, Teng E, Williams S, Masozera N, Horsfield M, Stanley M. Cognitive behavior therapy for late-life generalized anxiety disorder delivered by lay and expert providers has lasting benefits. Int J Geriatr Psychiatry. 2016 Nov;31(11):1225-1232. doi: 10.1002/gps.4431. Epub 2016 Feb 28.
PubMed 26923925Barrera TL, Cully JA, Amspoker AB, Wilson NL, Kraus-Schuman C, Wagener PD, Calleo JS, Teng EJ, Rhoades HM, Masozera N, Kunik ME, Stanley MA. Cognitive-behavioral therapy for late-life anxiety: Similarities and differences between Veteran and community participants. J Anxiety Disord. 2015 Jun;33:72-80. doi: 10.1016/j.janxdis.2015.04.005. Epub 2015 May 7.
PubMed 26005839
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Late-life GAD in Primary Care: Enhancing Outcomes and Translational Value
- ClinicalTrials.gov ID
- NCT00765219
- Acronym / sponsor ID
- H23798
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 2 Oct 2008 (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 treatment (CBT) can be delivered effectively by providers of different expertise levels 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 in later life. Given the potential difficulties in prescribing psychotropic medications in later life(e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternatives or adjuncts.
The treatment phase of this study lasts 6 months, during which patients will be randomly assigned to either cognitive behavior treatment (CBT) with an Anxiety Clinic Specialist (ACS) or Counselor or to Usual Care (UC). All participants will complete telephone assessments at baseline, 1, 2, and 3 months during the treatment phase. During the first 12 weeks, those assigned to CBT will also complete 10-12 weekly sessions, either in person or over the telephone. During the second 12 weeks, CBT patients will receive follow-up telephone booster calls, weekly for the first 4 weeks and biweekly for the last 8 weeks. During the treatment phase, UC participants will receive no treatment from study clinicians but will continue to receive their usual care from their current medical providers.
At 6 months, all participants will complete a telephone assessment. CBT patients will enter a one year follow-up period, with telephone assessments at 12 and 18 months. UC participants will be offered the option to receive brief CBT after completion of the 6 month telephone assessment. Those who choose to participate in CBT will complete telephone assessments at 9 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: CBTCBT with ACS |
| 2 | Experimental | Behavioral: CBTCBT with Counselor |
| 3 | Active comparator | Other: Usual CareUsual 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 and older
- Principal or Co-principal GAD diagnosis
- Patient at participating clinic
Key exclusion criteria (4 listed)
- Active suicidal intent
- Current psychosis or bipolar disorder
- Substance abuse within the past month
- Cognitive impairment according to a Mini Cog screener score of 3 or lower
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 |
|---|---|---|
| CBTAlso: Cognitive Behavior Treatment, Cognitive Behavior Therapy10-12 weekly sessions of CBT in person or over the telephone. | Behavioural | 1, 2 |
| Usual CareAlso: Treatment as UsualTreatment as usual provided by participants' physician(s) | Other | 3 |
Primary outcome
Anxiety
Time frame: 18 months
9 secondary outcomes
Depression
Time frame: 18 months
Sleep quality
Time frame: 18 months
Use of alcohol
Time frame: 18 months
Functional and health status
Time frame: 18 months
Quality of life
Time frame: 18 months
Pain
Time frame: 18 months
Satisfaction with CBT and general health care
Time frame: 18 months
Service utilization
Time frame: 18 months
Use of psychotropic medications
Time frame: 18 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 23 Jul 2015.
- Derived from this study: PubMed 26923925Freshour JS, Amspoker AB, Yi M, Kunik ME, Wilson N, Kraus-Schuman C, Cully JA, Teng E, Williams S, Masozera N, Horsfield M, Stanley M. Cognitive behavior therapy for late-life generalized anxiety disorder delivered by lay and expert providers has lasting benefits. Int J Geriatr Psychiatry. 2016 Nov;31(11):1225-1232. doi: 10.1002/gps.4431. Epub 2016 Feb 28.
- Derived from this study: PubMed 26005839Barrera TL, Cully JA, Amspoker AB, Wilson NL, Kraus-Schuman C, Wagener PD, Calleo JS, Teng EJ, Rhoades HM, Masozera N, Kunik ME, Stanley MA. Cognitive-behavioral therapy for late-life anxiety: Similarities and differences between Veteran and community participants. J Anxiety Disord. 2015 Jun;33:72-80. doi: 10.1016/j.janxdis.2015.04.005. Epub 2015 May 7.
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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, PhD 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 CBT 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 3 inclusion and 4 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 23 Jul 2015. 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: 18 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 NCT00765219, which also lists 2 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 23 Jul 2015.