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Designing a Mobile App for Veterans With Substance Use Problems

Primary Purpose

Substance Abuse Problem, Alcohol Abuse, Alcohol Dependence

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SHIFT Cognitive Behavioral Therapy
Sponsored by
Michael E. DeBakey VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse Problem focused on measuring Alcohol, Alcohol Abuse, Alcohol Dependence, Veterans

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Veteran of the Armed Forces
  2. are part of the primary care - mental health (PC-MH)
  3. reside in a rural community, as defined by the US Census Bureau
  4. score greater than or equal to 8 on the Alcohol Use Disorder Identification Test (AUDIT)
  5. meet diagnostic criteria for alcohol abuse or dependence as assessed by the Mini International Neuropsychiatric Inventory (MINI) according to the Diagnostic and Statistical Manual (DSM-IV)
  6. Age 18 and older to participate. -

Exclusion Criteria:

  1. Have conditions that threaten your safety (e.g., active suicidal intent, current uncontrolled psychosis or bipolar disorders in the past month as assessed by the MINI).

  2. Veterans with a diagnosed concurrent substance dependence (other than nicotine) and more than mild risk of alcohol withdrawal based on a score of greater than 8 on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) will be excluded.

    -

Sites / Locations

  • Michael E. DeBakey VA Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SHIFT Cognitive Behavioral Therapy

Arm Description

Service to Home for Individually-Focused Therapy (SHIFT), a Cognitive Behavioral Treatment for Substance Use Disorders

Outcomes

Primary Outcome Measures

Change

Secondary Outcome Measures

Full Information

First Posted
March 4, 2013
Last Updated
September 21, 2015
Sponsor
Michael E. DeBakey VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01812187
Brief Title
Designing a Mobile App for Veterans With Substance Use Problems
Official Title
Development of an Interactive, Adaptable and Transportable Treatment for Veterans With Substance Use Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michael E. DeBakey VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to increase access for rural Veterans to evidence-based, person-centered, individually tailored treatment for alcohol use problems. The primary aim is to evaluate the acceptability and feasibility of using mobile technology deliver treatment for alcohol use disorder. A mobile application will be used replacing the usual setting of clinical visits that accompanies standard face-to-face CBT therapy. The application will be loaded onto an iPod, which will be distributed to each participant that has been found to be eligible to participate.
Detailed Description
Many Veterans returning from Iraq and Afghanistan experience problems with drinking. There are treatments for alcohol use disorders that can be very helpful, but sometimes it can be hard for Veterans to find or participate in the treatments. This can be because of the amount of time the treatments take and the long distance to places where substance abuse treatments are offered. For Veterans who live in rural areas, these types of issues can pose even bigger problems. To address these issues, new types of treatments and ways of delivering care are being studied. We have developed a mobile application that will be accessed through the use of a mobile device such as an ipod. The application will contain an application dedicated to the treatment of substance abuse disorders. This application will provide the coping skills and educational information to aide in helping with problems associated with drinking alcohol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse Problem, Alcohol Abuse, Alcohol Dependence
Keywords
Alcohol, Alcohol Abuse, Alcohol Dependence, Veterans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHIFT Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Service to Home for Individually-Focused Therapy (SHIFT), a Cognitive Behavioral Treatment for Substance Use Disorders
Intervention Type
Behavioral
Intervention Name(s)
SHIFT Cognitive Behavioral Therapy
Other Intervention Name(s)
Service to Home for Individually Focused Therapy
Intervention Description
Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders
Primary Outcome Measure Information:
Title
Change
Time Frame
Change from baseline AUDIT score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Veteran of the Armed Forces are part of the primary care - mental health (PC-MH) reside in a rural community, as defined by the US Census Bureau score greater than or equal to 8 on the Alcohol Use Disorder Identification Test (AUDIT) meet diagnostic criteria for alcohol abuse or dependence as assessed by the Mini International Neuropsychiatric Inventory (MINI) according to the Diagnostic and Statistical Manual (DSM-IV) Age 18 and older to participate. - Exclusion Criteria: Have conditions that threaten your safety (e.g., active suicidal intent, current uncontrolled psychosis or bipolar disorders in the past month as assessed by the MINI). Veterans with a diagnosed concurrent substance dependence (other than nicotine) and more than mild risk of alcohol withdrawal based on a score of greater than 8 on the Clinical Institute Withdrawal Assessment of Alcohol (CIWA-Ar) will be excluded. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ken Woods
Phone
713-791-14141
Ext
2247
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Lindsay, Ph.D.
Organizational Affiliation
Baylor College of Medicine; Michael E. Debakey VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey VA Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77545
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ken Woods
Phone
713-791-1414
Ext
2247

12. IPD Sharing Statement

Learn more about this trial

Designing a Mobile App for Veterans With Substance Use Problems

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