search
Back to results

Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

Primary Purpose

Anxiety Disorders, Dementia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
Enhanced Usual Care (EUC)
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring Cognitive Behavior Therapy, Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Baylor College of Medicine
  • Michael E. DeBakey Veterans Affairs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-AD

EUC

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales

Secondary Outcome Measures

Quality of Life in Alzheimer's Disease (QOL-AD)
Geriatric Depression Scale (GDS)
Penn State Worry Questionnaire (PSWQ)
Geriatric Anxiety Inventory (GAI)

Full Information

First Posted
January 4, 2008
Last Updated
August 12, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT00596284
Brief Title
Cognitive Behavior Therapy for Treating Anxiety in People With Dementia
Official Title
Cognitive Behavior Therapy for Anxiety in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Dementia
Keywords
Cognitive Behavior Therapy, Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-AD
Arm Type
Experimental
Arm Description
Participants will receive Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
Arm Title
EUC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy of Anxiety in Dementia (CBT-AD)
Intervention Description
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
Intervention Name(s)
Enhanced Usual Care (EUC)
Intervention Description
Following in-person meetings, participants will receive weekly phone calls for 3 months, followed by biweekly phone calls for the next 3 months.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Quality of Life in Alzheimer's Disease (QOL-AD)
Time Frame
Measured at pre-treatment, post-treatment, and 3-month follow-up
Title
Geriatric Depression Scale (GDS)
Time Frame
Measured at pre-treatment, post-treatment, and 3-month follow-up
Title
Penn State Worry Questionnaire (PSWQ)
Time Frame
Measured at pre-treatment, post-treatment, and 3-month follow-up
Title
Geriatric Anxiety Inventory (GAI)
Time Frame
Measured at pre-treatment, post-treatment, and 3-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melinda A. Stanley, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Calleo, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

We'll reach out to this number within 24 hrs