AlcoholismNCT01389297
Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
A study testing SMART Recovery face-to-face meetings and Overcoming Addictions web application in people with Alcoholism, run by Behavior Therapy Associates, LLP at 1 site in United States.
Trial summary
The objective of this research project is to develop, evaluate, and disseminate an Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be based on the four point cognitive-behavioral program for SMART Recovery (www.smartrecovery.org). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- SMART Recovery face-to-face meetings and Overcoming Addictions web application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Minimum age 18.
- Positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days.
- An Alcohol Use Disorders Identification Test (AUDIT) score of 8+.
- Is a new member of SMART Recovery(i.e., just joining or joined within the last 4 weeks).
- Has a computer at home with Internet access.
- Has a primary focus on abstaining from drinking.
Who cannot join
- Court mandated 1st time DWI offenders.
- Current diagnosis of drug dependence or consider themselves to be drug dependent.
- Current evidence of uncontrolled psychosis or bipolar disorder.
- Evidence of significant cognitive impairment from brain dysfunction.
- English reading level below the 8th grade.
- Unwilling or unable to be available for 3 and 6 month post-baseline assessments.
- Unwilling or unable to provide one Significant Other (SO) for corroboration of participant's self-report of drinking and drug use (if any).
Trial locations and contacts
1 site in 1 country.
United States1 site
Behavior Therapy Associates, LLP
Albuquerque, New Mexico, 87112
About this study
The objective of this research project is to develop, evaluate, and disseminate an Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be based on the four point cognitive-behavioral program for SMART Recovery (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and behavioral skills to abstain from drinking, drug use, and problem gambling.
The investigators will evaluate the effectiveness of the OA web application for heavy drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.
Read more
The study design has three conditions: 1) participation in face-to-face SMART Recovery meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3) combining the OA web application with participation in face-to-face SMART Recovery meetings.
Study Hypotheses:
- All three groups will reduce their alcohol consumption, drug use (if any), and alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month post-baseline assessments.
- The OA only group (Experimental group 1) will show a greater reductions in drinking, drug use (if any), and alcohol/drug-related problems relative to the face-to-face only (Control) group.
- The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking and drug use variables compared to the Control group.
- Conditions
- Alcoholism
- Being tested
- SMART Recovery face-to-face meetings, Overcoming Addictions web application
- Keywords
- alcohol dependence intervention, Internet delivered intervention, alcohol dependence treatment, Internet delivered treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART Recovery face-to-face meetingsBehavioural
Attending these meetings at least weekly in frequency
Overcoming Addictions web applicationBehavioural
Logging into and using the web application at least weekly during the course of the study
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face SMART Recovery meetings | Active comparator | Participants in this arm will be asked to attend face-to-face SMART Recovery meetings. Receives: Behavioral: SMART Recovery face-to-face meetings |
| Overcoming Addictions web app | Experimental | Participants in this condition will use the Overcoming Addictions web application and not attend face-to-face SMART Recovery meetings. Receives: Behavioral: Overcoming Addictions web application |
| Web app + meetings | Experimental | Participants in this condition will be asked to use both the Overcoming Addictions web application and attend face-to-face SMART Recovery meetings. Receives: Behavioral: SMART Recovery face-to-face meetings; Behavioral: Overcoming Addictions web application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity/frequency of alcohol use: Form 90
Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.
Measured: 3 months
Quantity/frequency of alcohol use: Form 90
Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.
Measured: 6 months
Secondary outcomes (2)
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
The quantity and frequency of alcohol and drug related problems in the 90 days from the baseline assessment.
Measured: 3 months
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
The quantity and frequency of alcohol and drug related problems over the course of 90 days from 3-6 months from the baseline assessment.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Behavior Therapy Associates, LLP
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Reid K Hester, Ph.D., Principal investigator, Behavior Therapy Associates, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389297
- Sponsor's protocol ID
- SRWebCourseRCT
- Other IDs
- 2R44AA016237
- Status last verified
- Feb 2014
- First submitted
- 5 Jul 2011
- Last updated
- 25 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell W, Hester RK, Lenberg KL, Delaney HD. Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 2: Six-Month Outcomes of a Randomized Controlled Trial and Qualitative Feedback From Participants. J Med Internet Res. 2016 Oct 4;18(10):e262. doi: 10.2196/jmir.5508.
PubMed 27701064Hester RK, Lenberg KL, Campbell W, Delaney HD. Overcoming Addictions, a Web-based application, and SMART Recovery, an online and in-person mutual help group for problem drinkers, part 1: three-month outcomes of a randomized controlled trial. J Med Internet Res. 2013 Jul 11;15(7):e134. doi: 10.2196/jmir.2565.
PubMed 23846588
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Addictions: A Randomized Clinical Trial of a Web Application Based on SMART Recovery
- ClinicalTrials.gov ID
- NCT01389297
- Acronym / sponsor ID
- SRWebCourseRCT
- Conditions
- Alcoholism
- Keywords
- alcohol dependence intervention, Internet delivered intervention, alcohol dependence treatment, Internet delivered treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Behavior Therapy Associates, LLPIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 Jul 2011 (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 objective of this research project is to develop, evaluate, and disseminate an Internet-based (web) application for SMART Recovery: Overcoming Addictions (OA). OA will be based on the four point cognitive-behavioral program for SMART Recovery (www.smartrecovery.org). The goal of the OA program is to help users learn cognitive and behavioral skills to abstain from drinking, drug use, and problem gambling.
The investigators will evaluate the effectiveness of the OA web application for heavy drinkers in a randomized clinical trial (RCT) with follow-ups at 3- and 6-months.
The study design has three conditions: 1) participation in face-to-face SMART Recovery meetings alone; 2) use of the OA web application as a stand-alone intervention; and 3) combining the OA web application with participation in face-to-face SMART Recovery meetings.
Study Hypotheses:
- All three groups will reduce their alcohol consumption, drug use (if any), and alcohol/drug-related problems relative to their baseline levels at the 3- and 6-month post-baseline assessments.
- The OA only group (Experimental group 1) will show a greater reductions in drinking, drug use (if any), and alcohol/drug-related problems relative to the face-to-face only (Control) group.
- The OA + face-to-face group (Experimental group 2) will have better outcomes on drinking and drug use variables compared to the Control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Face-to-face SMART Recovery meetings | Active comparator | Behavioral: SMART Recovery face-to-face meetingsParticipants in this arm will be asked to attend face-to-face SMART Recovery meetings. |
| Overcoming Addictions web app | Experimental | Behavioral: Overcoming Addictions web applicationParticipants in this condition will use the Overcoming Addictions web application and not attend face-to-face SMART Recovery meetings. |
| Web app + meetings | Experimental | Behavioral: SMART Recovery face-to-face meetings, Behavioral: Overcoming Addictions web applicationParticipants in this condition will be asked to use both the Overcoming Addictions web application and attend face-to-face SMART Recovery meetings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Minimum age 18.
- Positive response to quantity/frequency screening questions regarding heavy drinking in the previous 90 days.
- An Alcohol Use Disorders Identification Test (AUDIT) score of 8+.
- Is a new member of SMART Recovery(i.e., just joining or joined within the last 4 weeks).
- Has a computer at home with Internet access.
Key exclusion criteria (7 listed)
- Court mandated 1st time DWI offenders.
- Current diagnosis of drug dependence or consider themselves to be drug dependent.
- Current evidence of uncontrolled psychosis or bipolar disorder.
- Evidence of significant cognitive impairment from brain dysfunction.
- English reading level below the 8th grade.
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 |
|---|---|---|
| SMART Recovery face-to-face meetingsAttending these meetings at least weekly in frequency | Behavioural | Face-to-face SMART Recovery meetings, Web app + meetings |
| Overcoming Addictions web applicationLogging into and using the web application at least weekly during the course of the study | Behavioural | Overcoming Addictions web app, Web app + meetings |
Primary outcome
Quantity/frequency of alcohol use: Form 90
Time frame: 3 months
Quantity/frequency of alcohol use over the course of 90 days prior to the baseline assessment.
Quantity/frequency of alcohol use: Form 90
Time frame: 6 months
Quantity/frequency of alcohol use over the course of 90 days from 3-6 months from the baseline assessment.
2 secondary outcomes
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Time frame: 3 months
Quantity and frequency of alcohol and drug related problems using the Inventory of Drug (and Alcohol) Use Consequences (InDuC)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2014.
- Derived from this study: PubMed 27701064Campbell W, Hester RK, Lenberg KL, Delaney HD. Overcoming Addictions, a Web-Based Application, and SMART Recovery, an Online and In-Person Mutual Help Group for Problem Drinkers, Part 2: Six-Month Outcomes of a Randomized Controlled Trial and Qualitative Feedback From Participants. J Med Internet Res. 2016 Oct 4;18(10):e262. doi: 10.2196/jmir.5508.
- Derived from this study: PubMed 23846588Hester RK, Lenberg KL, Campbell W, Delaney HD. Overcoming Addictions, a Web-based application, and SMART Recovery, an online and in-person mutual help group for problem drinkers, part 1: three-month outcomes of a randomized controlled trial. J Med Internet Res. 2013 Jul 11;15(7):e134. doi: 10.2196/jmir.2565.
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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.
Reid K Hester, Ph.D. principal investigator
Behavior Therapy Associates, LLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Recovery face-to-face meetings and Overcoming Addictions web application in people with Alcoholism, run by Behavior Therapy Associates, LLP 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 7 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: finished, as of the sponsor's last update on 25 Feb 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantity/frequency of alcohol use: Form 90 (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01389297, which also lists 2 linked publications.
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 25 Feb 2014.