NCT00765219

Brief Summary

The purpose of this study is to determine whether cognitive behavior treatment (CBT) can be delivered effectively by providers of different expertise levels 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
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2008

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

May 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

5.6 years

First QC Date

October 1, 2008

Last Update Submit

July 21, 2015

Conditions

Keywords

Generalized Anxiety DisorderGeriatric

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    18 months

Secondary Outcomes (9)

  • Depression

    18 months

  • Sleep quality

    18 months

  • Use of alcohol

    18 months

  • Functional and health status

    18 months

  • Quality of life

    18 months

  • +4 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

CBT with ACS

Behavioral: CBT

2

EXPERIMENTAL

CBT with Counselor

Behavioral: CBT

3

ACTIVE COMPARATOR

Usual Care

Other: Usual Care

Interventions

CBTBEHAVIORAL

10-12 weekly sessions of CBT in person or over the telephone.

Also known as: Cognitive Behavior Treatment, Cognitive Behavior Therapy
12

Treatment as usual provided by participants' physician(s)

Also known as: Treatment as Usual
3

Eligibility Criteria

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

You may qualify if:

  • Age 60 and older
  • Principal or Co-principal GAD diagnosis
  • Patient at participating clinic

You may not qualify if:

  • Active suicidal intent
  • Current psychosis or bipolar disorder
  • Substance abuse within the past month
  • Cognitive impairment according to a Mini Cog screener score of 3 or lower

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 (2)

  • Freshour JS, Amspoker AB, Yi M, Kunik ME, Wilson N, Kraus-Schuman C, Cully JA, Teng E, Williams S, Masozera N, Horsfield M, Stanley M. Cognitive behavior therapy for late-life generalized anxiety disorder delivered by lay and expert providers has lasting benefits. Int J Geriatr Psychiatry. 2016 Nov;31(11):1225-1232. doi: 10.1002/gps.4431. Epub 2016 Feb 28.

  • Barrera TL, Cully JA, Amspoker AB, Wilson NL, Kraus-Schuman C, Wagener PD, Calleo JS, Teng EJ, Rhoades HM, Masozera N, Kunik ME, Stanley MA. Cognitive-behavioral therapy for late-life anxiety: Similarities and differences between Veteran and community participants. J Anxiety Disord. 2015 Jun;33:72-80. doi: 10.1016/j.janxdis.2015.04.005. Epub 2015 May 7.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral TherapyTherapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Melinda A. Stanley, PhD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2013

Study Completion

April 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations