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Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

Phase 1
Completed
Conditions
Dementia
Anxiety Disorders
Interventions
Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
Behavioral: Enhanced Usual Care (EUC)
Registration Number
NCT00596284
Lead Sponsor
Baylor College of Medicine
Brief Summary

This study will evaluate the effectiveness of cognitive behavioral therapy in treating anxiety in older adults with dementia.

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 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
34
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
CBT-ADCognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)Participants will receive Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
EUCEnhanced Usual Care (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.
Primary Outcome Measures
NameTimeMethod
Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscalesMeasured at pre-treatment, post-treatment, and 3-month follow-up
Secondary Outcome Measures
NameTimeMethod
Geriatric Depression Scale (GDS)Measured at pre-treatment, post-treatment, and 3-month follow-up
Quality of Life in Alzheimer's Disease (QOL-AD)Measured at pre-treatment, post-treatment, and 3-month follow-up
Penn State Worry Questionnaire (PSWQ)Measured at pre-treatment, post-treatment, and 3-month follow-up
Geriatric Anxiety Inventory (GAI)Measured at pre-treatment, post-treatment, and 3-month follow-up

Trial Locations

Locations (2)

Baylor College of Medicine

🇺🇸

Houston, Texas, United States

Michael E. DeBakey Veterans Affairs Medical Center

🇺🇸

Houston, Texas, United States

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