Back to resultsEffectiveness of Extended Telephone Monitoring (ETM)
Primary Purpose
Alcohol Dependence
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Telephone Monitoring and Feedback
Telephone Monitoring and Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Dependence
Eligibility Criteria
Inclusion Criteria: enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP); willingness to participate in research and be randomized; 4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963); able to provide the names of several informants who will know his/her whereabouts during the follow-up period Exclusion Criteria: acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication); IV heroin use during the past year; anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
TAU
Telephone Monitoring
Telephone Monitoring and Counseling
Arm Description
Outcomes
Primary Outcome Measures
TimeLineFollowBack
Secondary Outcome Measures
Full Information
NCT ID
NCT00194103
First Posted
September 12, 2005
Last Updated
June 25, 2010
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT00194103
Brief Title
Effectiveness of Extended Telephone Monitoring
Acronym
ETM
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Pennsylvania
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the effectiveness of extended telephone monitoring for alcohol-dependent patients receiving intensive outpatient treatment. It is hypothesized that telephone monitoring will produce better alcohol use outcomes relative to treatment as usual. It is also hypothesized that adaptive telephone monitoring plus brief counseling will produce better alcohol use outcomes over time relative to telephone monitoring plus feedback only.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
252 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAU
Arm Type
No Intervention
Arm Title
Telephone Monitoring
Arm Type
Active Comparator
Arm Title
Telephone Monitoring and Counseling
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Telephone Monitoring and Feedback
Intervention Description
In addition to attending IOP, participants receive phone contact from our counselors but only to receive a monitoring assessment. There is no feedback or counseling from study staff in this condition.
Intervention Type
Behavioral
Intervention Name(s)
Telephone Monitoring and Counseling
Intervention Description
In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
Primary Outcome Measure Information:
Title
TimeLineFollowBack
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
enrolled in Intensive Outpatient substance abuse treatment for at least 2 and no more than 4 weeks at study entry
qualify for a current DSM-IV diagnosis of alcohol dependence (during the month prior to entrance into the IOP or detoxification program prior to IOP);
willingness to participate in research and be randomized;
4th grade reading level (as determined by the Slosson Oral Reading Test; Slosson, 1963);
able to provide the names of several informants who will know his/her whereabouts during the follow-up period
Exclusion Criteria:
acute medical or psychiatric problems that preclude outpatient treatment (e.g., in a psychotic episode and not stabilized on medication);
IV heroin use during the past year;
anticipated involvement in other forms of intensive treatment (e.g., inpatient) during the 6-month period after enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James McKay, Ph. D.
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Effectiveness of Extended Telephone Monitoring
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