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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00596284 |
Purpose
This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety Disorders Dementia |
Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD) Behavioral: Enhanced Usual Care (EUC) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study |
| Official Title: | Cognitive Behavior Therapy for Anxiety in Dementia |
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
CBT-AD: Experimental
Participants will receive Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
|
Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
Cognitive behavioral therapy (CBT) will consist of 8 to 10 sessions 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: Active Comparator
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 half-day Cognitive Behavior Workshop.
|
Behavioral: Enhanced Usual Care (EUC)
Following in-person meetings, participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months.
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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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jessica Calleo, PhD | 713-794-8521 | jcalleo@bcm.tmc.edu |
| United States, Texas | |
| Michael E. DeBakey Veterans Affairs Medical Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Melinda A. Stanley, PhD 713-794-8841 mstanley@bcm.tmc.edu | |
| Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Melinda A. Stanley, PhD 713-794-8841 mstanley@bcm.tmc.edu | |
| Principal Investigator: | Melinda A. Stanley, PhD | Baylor College of Medicine |
| Study Director: | Jessica Calleo, PhD | Baylor College of Medicine |
More Information
| Responsible Party: | Baylor College of Medicine ( Melinda A. Stanley, PhD ) |
| Study ID Numbers: | R34 MH078925, DATR A4-GPS |
| Study First Received: | January 4, 2008 |
| Last Updated: | March 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00596284 History of Changes |
| Health Authority: | United States: Federal Government |
|
Cognitive Behavior Therapy Alzheimer's Disease |
|
Delirium, Dementia, Amnestic, Cognitive Disorders Anxiety Disorders Mental Disorders Nervous System Diseases |
Central Nervous System Diseases Brain Diseases Dementia |