Cognitive Behavior Therapy for Treating Anxiety in People With Dementia

Dementia Clinical Trial

Official title:

Cognitive Behavior Therapy for Anxiety in Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596284
• Other study ID #: R34MH078925
• Secondary ID: R34MH078925DATR
• Status: Completed
• Phase: Phase 1
• First received: January 4, 2008
• Last updated: August 12, 2015
• Start date: January 2008
• Est. completion date: June 2010

Study information

• Verified date: August 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Dementia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Anxiety in Dementia (RAID) and Neuropsychiatric Inventory (NPI)- Anxiety subscales		Measured at pre-treatment, post-treatment, and 3-month follow-up	No
Secondary	Quality of Life in Alzheimer's Disease (QOL-AD)		Measured at pre-treatment, post-treatment, and 3-month follow-up	No
Secondary	Geriatric Depression Scale (GDS)		Measured at pre-treatment, post-treatment, and 3-month follow-up	No
Secondary	Penn State Worry Questionnaire (PSWQ)		Measured at pre-treatment, post-treatment, and 3-month follow-up	No
Secondary	Geriatric Anxiety Inventory (GAI)		Measured at pre-treatment, post-treatment, and 3-month follow-up	No