Cognitive Behavior Therapy for Treating Anxiety in People With Dementia - NCT00596284-77030A (Clinical Trial 198557)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy198557.aspx
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| City: |
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Houston |
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State:
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TX |
| Zip Code: |
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77030 |
| Conditions: |
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Anxiety Disorders - Dementia |
| Purpose: |
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This study will evaluate the effectiveness of cognitive behavioral therapy in treating
anxiety in older adults with dementia.
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| Study summary: |
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Dementia is an illness that causes memory problems; changes in behavior; and difficulty with
thinking, making decisions, and carrying out daily activities. Many people with dementia
also have anxiety, and yet very little is known about effective treatment strategies for
anxiety in this population. Cognitive behavioral therapy (CBT) is a type of psychotherapy
that is commonly used to treat anxiety. CBT involves teaching patients skills to help them
manage their anxiety, such as relaxation, changing their thoughts, and problem-solving. This
study will evaluate the effectiveness of CBT in treating anxiety in older adults with
dementia. In addition, the study will determine the effect of the treatment on patients'
families and friends, and how families and friends may be able to help patients manage their
anxiety. All study participants will name a family member or friend who will also
participate in the study.
All participants in this study will answer a preliminary set of questions about anxiety and
memory and will then complete a number of activities that involve learning and memory. These
evaluations will take approximately 45 minutes. Participants who are selected to continue in
the study will answer a second set of questions about mood, memory, concentration, and how
they are doing in certain areas of life. These interview questions will take place during 2
sessions and will last a total of approximately 3 hours. Participants will then be randomly
assigned to receive either enhanced usual care (EUC) or 8 to 10 sessions of CBT over a
period of 10 to 12 weeks. Each CBT session will last about 1 hour and will include meeting
with a study staff member to discuss anxiety and how to cope with it. Participants will also
complete practice activities at home for about 20 minutes per day. EUC will consist of
regular ongoing care from healthcare providers and phone assessments at 1-month and 2-month.
Following the 6 month assessment, participants in EUC will be offered a Cognitive Behavior
Workshop. Following in-person meetings, CBT participants will receive weekly phone calls for
3 months, followed by biweekly phone calls for the next 3 months. Some of the pretreatment
questions will be asked again at 3 months and again 6 months after baseline. |
| Criteria: |
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Inclusion Criteria:
- Alzheimer's disease that is in the mild or moderate range according to a score of 0.5
to 2.0 on the Clinical Dementia Rating (CDR) Scale
- Significant anxiety as defined by a score of 4 on the Neuropsychiatric Inventory
(NPI)
- Agrees to permit participation of a collateral
- English-speaking
Exclusion Criteria:
- Suicidal intent
- Current psychosis or bipolar disorder
- History of substance abuse within 1 month prior to study entry |
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| Study is available at: |
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Michael E. DeBakey Veterans Affairs Medical Center
Houston, TX 77030
United States
Primary Contact:
Melinda A. Stanley, PhD
Email: mstanley@bcm.tmc.edu
Phone: 713-794-8841
Secondary Contact:
Jessica Calleo, PhD
Email: jcalleo@bcm.tmc.edu
Phone: 713-794-8521 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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