Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

NCT ID: NCT00596284

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2010-06-30

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.

Conditions

Anxiety Disorders; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBT-AD

Participants will receive Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care (EUC)

Intervention Type: BEHAVIORAL

Following in-person meetings, participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Melinda Stanley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda A. Stanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Jessica Calleo, PhD

Role: STUDY_DIRECTOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, United States

Countries

United States

Other Identifiers

R34MH078925

Identifier Type: NIH

Identifier Source: secondary_id

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DATR A4-GPS

Identifier Type: -

Identifier Source: secondary_id

R34MH078925

Identifier Type: NIH

Identifier Source: org_study_id

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