Cognitive Behavior Therapy for Treating Anxiety in People With Dementia
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ClinicalTrials.gov Identifier: NCT00596284 |
Recruitment Status :
Completed
First Posted : January 16, 2008
Last Update Posted : August 13, 2015
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Condition or disease | Intervention/treatment | Phase |
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Anxiety Disorders Dementia | Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD) Behavioral: Enhanced Usual Care (EUC) | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cognitive Behavior Therapy for Anxiety in Dementia |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | June 2010 |
Actual Study Completion Date : | June 2010 |

Arm | Intervention/treatment |
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Experimental: CBT-AD
Participants will receive Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
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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. |
Active Comparator: EUC
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. |
- Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ]
- Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ]
- Geriatric Depression Scale (GDS) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ]
- Penn State Worry Questionnaire (PSWQ) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ]
- Geriatric Anxiety Inventory (GAI) [ Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596284
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
Michael E. DeBakey Veterans Affairs Medical Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Melinda A. Stanley, PhD | Baylor College of Medicine | |
Study Director: | Jessica Calleo, PhD | Baylor College of Medicine |
Responsible Party: | Melinda Stanley, Professor, Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00596284 |
Other Study ID Numbers: |
R34MH078925 ( U.S. NIH Grant/Contract ) R34MH078925 ( U.S. NIH Grant/Contract ) DATR A4-GPS |
First Posted: | January 16, 2008 Key Record Dates |
Last Update Posted: | August 13, 2015 |
Last Verified: | August 2015 |
Cognitive Behavior Therapy Alzheimer's Disease |
Dementia Anxiety Disorders Mental Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders |