Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

August 12, 2015 updated by: Melinda Stanley, Baylor College of Medicine

Cognitive Behavior Therapy for Anxiety in Dementia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey Veterans Affairs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales
Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up
Measured at pre-treatment, post-treatment, and 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life in Alzheimer's Disease (QOL-AD)
Time Frame: Measured at pre-treatment, post-treatment, and 3-month follow-up
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
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
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
Measured at pre-treatment, post-treatment, and 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH078925 (U.S. NIH Grant/Contract)
  • DATR A4-GPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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