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Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), February 2008

Sponsored by: 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

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Disease    Anxiety    Dementia   

U.S. FDA Resources

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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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
Participants will receive enhanced usual care (EUC)
Behavioral: Enhanced Usual Care (EUC)
EUC 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.

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 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. 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.

  Eligibility
Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596284

Contacts
Contact: Thomas D. McNeese, MEd     713-794-8521     mcneese@bcm.tmc.edu    

Locations
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    

Sponsors and Collaborators

Investigators
Principal Investigator:     Melinda A. Stanley, PhD     Baylor College of Medicine    
Study Director:     Thomas D. McNeese, MEd     Baylor College of Medicine    
  More Information

Responsible Party:   Baylor College of Medicine ( Melinda A. Stanley, PhD )
Study ID Numbers:   R34 MH078925, DATR A4-GPS
First Received:   January 4, 2008
Last Updated:   February 11, 2008
ClinicalTrials.gov Identifier:   NCT00596284
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavior Therapy  
Alzheimer's Disease  

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Anxiety Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2008




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