NCT00596284

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

January 4, 2008

Last Update Submit

August 12, 2015

Conditions

Anxiety DisordersDementia

Keywords

Cognitive Behavior TherapyAlzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (4)

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

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

  • Geriatric Depression Scale (GDS)

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

  • Penn State Worry Questionnaire (PSWQ)

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

  • Geriatric Anxiety Inventory (GAI)

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

Study Arms (2)

CBT-AD

EXPERIMENTAL

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

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

EUC

ACTIVE COMPARATOR

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)

Interventions

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.

CBT-AD
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.

EUC

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Suicidal intent
  • Current psychosis or bipolar disorder
  • History of substance abuse within 1 month prior to study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Anxiety DisordersDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Mental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersTauopathiesNeurodegenerative Diseases

Study Officials

  • Melinda A. Stanley, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

  • Jessica Calleo, PhD

    Baylor College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(2)