NCT01812187

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2013

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.1 years

First QC Date

March 4, 2013

Last Update Submit

September 21, 2015

Conditions

Keywords

AlcoholAlcohol AbuseAlcohol DependenceVeterans

Outcome Measures

Primary Outcomes (1)

  • Change

    Change from baseline AUDIT score at 3 months

Study Arms (1)

SHIFT Cognitive Behavioral Therapy

EXPERIMENTAL

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

Behavioral: SHIFT Cognitive Behavioral Therapy

Interventions

Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders

Also known as: Service to Home for Individually Focused Therapy
SHIFT Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center

Houston, Texas, 77545, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersAlcoholism

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersAlcohol-Related Disorders

Study Officials

  • Jan A Lindsay, Ph.D.

    Baylor College of Medicine; Michael E. Debakey VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ken Woods

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 4, 2013

First Posted

March 18, 2013

Study Start

April 1, 2015

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations