NCT00938093

Brief Summary

The research study proposed is designed to examine the outcomes of a cognitive behavioral guided self-care intervention with older adults diagnosed with generalized anxiety disorder and recruited from a primary care setting. It is hypothesized that the cognitive behavioral guided self-care intervention will produce greater declines in worry and anxiety than enhanced usual care.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Typical duration for not_applicable

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

March 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

July 10, 2009

Last Update Submit

August 9, 2018

Conditions

Generalized Anxiety DisorderPanic DisorderAnxiety Disorder Not Otherwise Specified

Outcome Measures

Primary Outcomes (2)

  • PSWQ-A

    4 months

  • HAM-A

    4 months

Study Arms (2)

Cognitive-behavioral therapy

ACTIVE COMPARATOR

cognitive-behavioral therapy

Behavioral: Cognitive behavioral therapy

Enhanced usual care

PLACEBO COMPARATOR

enhanced usual care

Behavioral: Enhanced usual care

Interventions

Cognitive behavioral therapyBEHAVIORAL

Participants receive 10 telephone therapy sessions and an accompanying workbook focused on cognitive-behavioral techniques for managing anxiety.

Cognitive-behavioral therapy
Enhanced usual careBEHAVIORAL

Participants receive written information about anxiety, referrals for treatment, and an optional letter to their primary care physician.

Enhanced usual care

Eligibility Criteria

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

You may qualify if:

  • age ≥ 60 years
  • a DSM-IV diagnosis of GAD
  • able to read English.

You may not qualify if:

  • current psychotherapy
  • a DSM-IV diagnosis of alcohol or substance abuse
  • a diagnosis of dementia or global cognitive impairment operationalized as a score of \< 24 of the Mini-Mental Status Examination
  • psychotic symptoms
  • active suicidal ideation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Generalized Anxiety DisorderPanic Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Gretchen Brenes, PhD

    Wake Forest University Health Sciences

    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
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

March 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 13, 2018

Record last verified: 2018-08