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

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Melinda Stanley, Baylor College of Medicine

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders Dementia	Behavioral: Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD) Behavioral: Enhanced Usual Care (EUC)	Phase 1

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.

Study Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Dementia

Genetic and Rare Diseases Information Center resources: Familial Alzheimer Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

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 ]

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 ]
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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	50 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Melinda A. Stanley, PhD	Baylor College of Medicine
Study Director:	Jessica Calleo, PhD	Baylor College of Medicine

More Information


Responsible Party:	Melinda Stanley, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00596284 History of Changes
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

Keywords provided by Melinda Stanley, Baylor College of Medicine:


Cognitive Behavior Therapy Alzheimer's Disease

Additional relevant MeSH terms:


Anxiety Disorders Dementia Mental Disorders Brain Diseases	Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders

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