Designing a Mobile App for Veterans With Substance Use Problems

Alcohol Dependence Clinical Trial

Official title:

Development of an Interactive, Adaptable and Transportable Treatment for Veterans With Substance Use Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01812187
• Other study ID #: H-30374
• Status: Recruiting
• Phase: N/A
• First received: March 4, 2013
• Last updated: September 21, 2015
• Start date: April 2015
• Est. completion date: May 2017

Study information

• Verified date: September 2015
• Source: Michael Debakey Veterans Affairs Medical Center
• Contact: Ken Woods
• Phone: 713-791-14141
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Dependence
• Alcoholism
• Substance Abuse Problem
• Substance-Related Disorders

Intervention

Behavioral:
• SHIFT Cognitive Behavioral Therapy
Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders

Locations

Country	Name	City	State
United States	Michael E. DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Michael Debakey Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change		Change from baseline AUDIT score at 3 months	No