NCT01685528

Brief Summary

The purpose of this study is to determine the feasibility and acceptability of providing evidence-based, person-centered, culturally tailored treatment for anxiety and/or depression via telephone to rural Veterans receiving home-based primary care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable anxiety

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

First Submitted

Initial submission to the registry

September 12, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.4 years

First QC Date

September 12, 2012

Last Update Submit

April 5, 2016

Conditions

AnxietyDepression

Keywords

AnxietyDepressionGeriatricVeteran

Outcome Measures

Primary Outcomes (3)

  • Geriatric Anxiety Inventory

    12 weeks

  • Penn State Worry Questionnaire (PSWQ-A)

    12 weeks

  • Generalized Anxiety Disorder-7

    12 weeks

Secondary Outcomes (8)

  • SF-12 Health Survey

    12 weeks

  • Brief RCOPE

    12 weeks

  • Client Satisfaction Questionnaire

    12 weeks

  • Patient Health Questionnaire-9

    12 weeks

  • Geriatric Depression Scale

    12 weeks

  • +3 more secondary outcomes

Study Arms (1)

CBT

EXPERIMENTAL
Behavioral: CBT

Interventions

CBTBEHAVIORAL

6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Part of Home-Based Primary Care
  • Reside in a rural community, as defined by the US Census Bureau
  • Symptoms of anxiety and/or depression

You may not qualify if:

  • Significant cognitive impairment
  • Active suicidal intent
  • Current uncontrolled psychosis, bipolar, or substance-abuse disorders within the past month

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

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2012

First Posted

September 14, 2012

Study Start

December 1, 2012

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

US(1)