Dementia Clinical Trial
Official title:
Cognitive Behavior Therapy for Anxiety in Dementia
This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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