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Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00596284
First received: January 4, 2008
Last updated: November 6, 2013
Last verified: March 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavior Therapy for Anxiety in Dementia

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

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 ]

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 ]

Enrollment: 34
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-AD
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.
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.

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.

  Eligibility

Ages Eligible for Study:   50 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Melinda A. Stanley, PhD Baylor College of Medicine
Study Director: Jessica Calleo, PhD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Melinda A. Stanley, PhD, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00596284     History of Changes
Other Study ID Numbers: R34 MH078925, R34MH078925, DATR A4-GPS
Study First Received: January 4, 2008
Last Updated: November 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
Cognitive Behavior Therapy
Alzheimer's Disease

Additional relevant MeSH terms:
Anxiety Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on November 27, 2014