ClinicalTrials.gov
ClinicalTrials.gov Menu

Designing a Mobile App for Veterans With Substance Use Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01812187
Recruitment Status : Unknown
Verified September 2015 by Jan Lindsay, Ph.D., Michael Debakey Veterans Affairs Medical Center.
Recruitment status was:  Recruiting
First Posted : March 18, 2013
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
Jan Lindsay, Ph.D., Michael Debakey Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Substance Abuse Problem Alcohol Abuse Alcohol Dependence Behavioral: SHIFT Cognitive Behavioral Therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of an Interactive, Adaptable and Transportable Treatment for Veterans With Substance Use Disorders
Study Start Date : April 2015
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : May 2017

Arm Intervention/treatment
Experimental: SHIFT Cognitive Behavioral Therapy
Service to Home for Individually-Focused Therapy (SHIFT), a Cognitive Behavioral Treatment for Substance Use Disorders
Behavioral: SHIFT Cognitive Behavioral Therapy
Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders
Other Name: Service to Home for Individually Focused Therapy




Primary Outcome Measures :
  1. Change [ Time Frame: Change from baseline AUDIT score at 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01812187


Contacts
Contact: Ken Woods 713-791-14141 ext 2247

Locations
United States, Texas
Michael E. DeBakey VA Medical Center Recruiting
Houston, Texas, United States, 77545
Contact: Ken Woods    713-791-1414 ext 2247      
Sponsors and Collaborators
Michael Debakey Veterans Affairs Medical Center
Investigators
Principal Investigator: Jan A Lindsay, Ph.D. Baylor College of Medicine; Michael E. Debakey VA Medical Center

Responsible Party: Jan Lindsay, Ph.D., Principal Investigator, Michael Debakey Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT01812187     History of Changes
Other Study ID Numbers: H-30374
First Posted: March 18, 2013    Key Record Dates
Last Update Posted: September 23, 2015
Last Verified: September 2015

Keywords provided by Jan Lindsay, Ph.D., Michael Debakey Veterans Affairs Medical Center:
Alcohol
Alcohol Abuse
Alcohol Dependence
Veterans

Additional relevant MeSH terms:
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders