Substance Abuse ProblemNCT01812187
Designing a Mobile App for Veterans With Substance Use Problems
A study testing SHIFT Cognitive Behavioral Therapy in people with Substance Abuse Problem and Alcohol Abuse, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse Problem, Alcohol Abuse, Alcohol Dependence
- What is being tested?
- SHIFT Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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. -
Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country.
Ken Woods contact
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey VA Medical Center
Houston, Texas, 77545
Ken Woods, 713-791-1414 ext. 2247
About this study
Official title: Development of an Interactive, Adaptable and Transportable Treatment for Veterans With Substance Use Disorders
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.
Read the 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.
- Conditions
- Substance Abuse Problem, Alcohol Abuse, Alcohol Dependence
- Being tested
- SHIFT Cognitive Behavioral Therapy
- Keywords
- Alcohol, Alcohol Abuse, Alcohol Dependence, Veterans
- Medical subject headings
- Substance-Related Disorders, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHIFT Cognitive Behavioral TherapyBehavioural
Also called Service to Home for Individually Focused Therapy
Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders
| Study group | Role | What they receive |
|---|---|---|
| SHIFT Cognitive Behavioral Therapy | Experimental | Service to Home for Individually-Focused Therapy (SHIFT), a Cognitive Behavioral Treatment for Substance Use Disorders Receives: Behavioral: SHIFT Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change
Measured: Change from baseline AUDIT score at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2013 (estimated)
- Study startApr 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Abuse ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael E. DeBakey VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jan Lindsay, Ph.D., Michael E. DeBakey VA Medical Center
- Investigators
- Jan A Lindsay, Ph.D., Principal investigator, Baylor College of Medicine; Michael E. Debakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812187
- Sponsor's protocol ID
- H-30374
- Status last verified
- Sep 2015
- First submitted
- 4 Mar 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Interactive, Adaptable and Transportable Treatment for Veterans With Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01812187
- Acronym / sponsor ID
- H-30374
- Conditions
- Substance Abuse Problem, Alcohol Abuse, Alcohol Dependence
- Keywords
- Alcohol, Alcohol Abuse, Alcohol Dependence, Veterans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Michael E. DeBakey VA Medical CenterUS federal agency
- Study start
- Apr 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 18 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHIFT Cognitive Behavioral Therapy | Experimental | Behavioral: SHIFT Cognitive Behavioral TherapyService to Home for Individually-Focused Therapy (SHIFT), a Cognitive Behavioral Treatment for Substance Use Disorders |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHIFT Cognitive Behavioral TherapyAlso: Service to Home for Individually Focused TherapyManualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders | Behavioural | SHIFT Cognitive Behavioral Therapy |
Primary outcome
Change
Time frame: Change from baseline AUDIT score at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Woods contact
Jan A Lindsay, Ph.D. principal investigator
Baylor College of Medicine; Michael E. Debakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SHIFT Cognitive Behavioral Therapy in people with Substance Abuse Problem and Alcohol Abuse, run by Michael E. DeBakey VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ken Woods (713-791-14141 ext. 2247), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change (time frame: Change from baseline AUDIT score at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.