NCT00308724

Brief Summary

The purpose of this study is to determine whether cognitive behavior therapy (CBT) is effective in the treatment of generalized anxiety disorder (GAD) in adults age 60 and older in a primary care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
7.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

3.8 years

First QC Date

March 28, 2006

Last Update Submit

March 21, 2024

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety DisorderGeriatric

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    Baseline and 3, 6, 9, 12 and 15 months

Secondary Outcomes (7)

  • Functional and health status

    Baseline and 3, 6, 9, 12 and 15 months

  • Quality of life inventory (QOLI)

    Baseline and 3, 6, 9, 12 and 15 months

  • Satisfaction with CBT and general health care

    Baseline and 3, 6, 9, 12 and 15 months

  • Service utilization

    Baseline and 3, 6, 9, 12 and 15 months

  • Depression

    Baseline and 3, 6, 9, 12 and 15 months

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Cognitive Behavior Therapy

Behavioral: Cognitive Behavior Therapy

2

ACTIVE COMPARATOR

Usual Care

Behavioral: Telephone check-in

Interventions

Cognitive Behavior TherapyBEHAVIORAL

8 to 10 in person CBT sessions up to 60 minutes in duration within a 12 week time period

Also known as: CBT
1
Telephone check-inBEHAVIORAL

Biweekly telephone calls to monitor symptom severity, an enhanced Usual Care condition

2

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Generalized Anxiety Disorder

You may not qualify if:

  • Active suicidal intent
  • Current psychosis
  • Current bipolar disorder
  • Substance abuse within past month
  • Cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Houston Center for Quality of Care and Utilization Studies

Houston, Texas, 77030, United States

Location

Related Publications (5)

  • Wetherell JL, Lenze EJ, Stanley MA. Evidence-based treatment of geriatric anxiety disorders. Psychiatr Clin North Am. 2005 Dec;28(4):871-96, ix. doi: 10.1016/j.psc.2005.09.006. No abstract available.

    PMID: 16325733BACKGROUND

  • Stanley MA, Kunik ME. Anxiety in primary care: a frontier for mental health services research. Med Care. 2005 Dec;43(12):1161-3. doi: 10.1097/01.mlr.0000190923.04095.80. No abstract available.

    PMID: 16299425BACKGROUND

  • Stanley MA, Hopko DR, Diefenbach GJ, Bourland SL, Rodriguez H, Wagener P. Cognitive-behavior therapy for late-life generalized anxiety disorder in primary care: preliminary findings. Am J Geriatr Psychiatry. 2003 Jan-Feb;11(1):92-6.

    PMID: 12527544BACKGROUND

  • Shrestha S, Stanley MA, Wilson NL, Cully JA, Kunik ME, Novy DM, Rhoades HM, Amspoker AB. Predictors of change in quality of life in older adults with generalized anxiety disorder. Int Psychogeriatr. 2015 Jul;27(7):1207-15. doi: 10.1017/S1041610214002567. Epub 2014 Dec 12.

    PMID: 25497362DERIVED

  • Stanley MA, Wilson NL, Novy DM, Rhoades HM, Wagener PD, Greisinger AJ, Cully JA, Kunik ME. Cognitive behavior therapy for generalized anxiety disorder among older adults in primary care: a randomized clinical trial. JAMA. 2009 Apr 8;301(14):1460-7. doi: 10.1001/jama.2009.458.

    PMID: 19351943DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melinda A. Stanley, Ph.D.

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
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

March 28, 2006

First Posted

March 30, 2006

Study Start

March 1, 2004

Primary Completion

January 1, 2008

Study Completion

April 1, 2015

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

US(1)