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| Descriptive Information Fields | |||||||||
| Brief Title † | Cognitive Behavior Therapy for Treating Anxiety in People With Dementia | ||||||||
| Official Title † | Cognitive Behavior Therapy for Anxiety in Dementia | ||||||||
| Brief Summary | This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia. |
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| Detailed Description | 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 half-day Cognitive Behavior Workshop. Enhanced usual care will consist of regular ongoing care from healthcare providers and biweekly phone calls for 3 months, followed by monthly phone calls for the next 3 months. Some of the pretreatment questions will be asked again immediately after the treatment period has been completed and again 3 months later for all participants. |
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| Study Phase | Phase I | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Single Blind (Outcomes Assessor), Historical Control, Single Group Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] Geriatric Depression Scale (GDS) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] Penn State Worry Questionnaire (PSWQ) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] Geriatric Anxiety Inventory (GAI) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ] [ Designated as safety issue: No ] |
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| Condition † | Anxiety Disorders Dementia |
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| Intervention † | Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD) Behavioral: Enhanced Usual Care (EUC) |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 50 | ||||||||
| Start Date † | January 2008 | ||||||||
| Completion Date | June 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 60 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00596284 | ||||||||
| Organization ID | R34 MH078925 | ||||||||
| Secondary IDs †† | DATR A4-GPS | ||||||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||
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| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | August 2008 | ||||||||
| First Received Date † | January 4, 2008 | ||||||||
| Last Updated Date | August 26, 2008 | ||||||||
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