Using Smart Phone Technology To Rural Veterans | NCT01346228

Studies
Using Smart Phone Technology To Rural Veterans

NCT01346228

Sponsor

Michael E. DeBakey VA Medical Center

Status

Unknown status

Last Update Posted

May 2, 2011Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Panic Disorders
Anxiety Disorders

Interventions

Panic Control Treatment (PCT)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

May 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Apr 29, 2011

First Submission Date that Met QC Criteria

Apr 29, 2011

First Posted Date

May 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Michael E. DeBakey VA Medical CenterFED

Collaborators

Name	Class
South Central VA Mental Illness Research, Education & Clinical Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to see if a new Smart Phone application can help Veterans manage their panic symptoms after completing a two-day treatment for panic attacks.

Detailed Description

The first goal is to see how helpful the Smart Phone application is in helping veterans with panic symptoms continue to improve after you complete treatment.

The second goal of this study is to find out how much veterans like the Smart Phone application.

The third goal is to see how practical it is to use the Smart Phone application as a form of follow-up care. We want to see how much time is needed to provide technical support in using the application.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Panic Control Treatment (PCT)	Behavioral	2 Day treatment for Panic Disorder		Panic Group Weekend Panic Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Panic Control Treatment (PCT)	A cognitive-behavioral therapy for PD that is highly efficacious, the standard delivery format of these sessions are typically offered once a week over a period of several months. This can pose challenges to rural Veterans who have multiple commitments and face long travel distances for mental health services. To improve accessibility to panic treatment, one innovative approach has been to deliver PCT in an intensive, two-day format.	2 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants must

be an Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veteran
currently meet criteria for PD with or without Agoraphobia
complete the weekend PD treatment at the Lufkin, Conroe or Texas City CBOC.

Exclusion Criteria:

current substance dependence
organic psychosis
symptomatic bipolar disorder
severe depression with suicidal intent or plan
cognitive impairment (indicated by scores <20 on SLUMS)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ken Woods	Contact	713-791-1414	2247	ken.woods@va.gov

Overall Officials

Name	Affiliation	Role
Ellen Teng, Ph.D	Michael E. DeBakey VA Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Michael E. DeBakey VA Medical Center		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D016584	Panic Disorder
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided