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Completed

NCT Number: NCT00596284

Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baylor College of Medicine, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

enhanced usual care (EUC)

Behavioral

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

Primary outcomes

  1. 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 outcomes

  1. Quality of Life in Alzheimer's Disease (QOL-AD)

    Time frame: Measured at pre-treatment, post-treatment, and 3-month follow-up

  2. Geriatric Depression Scale (GDS)

    Time frame: Measured at pre-treatment, post-treatment, and 3-month follow-up

  3. Penn State Worry Questionnaire (PSWQ)

    Time frame: Measured at pre-treatment, post-treatment, and 3-month follow-up

  4. Geriatric Anxiety Inventory (GAI)

    Time frame: Measured at pre-treatment, post-treatment, and 3-month follow-up

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Cognitive Behavior Therapy for Anxiety in Dementia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 16, 2008
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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