Effectiveness of Extended Telephone Monitoring
ETM
2 other identifiers
interventional
252
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2004
Longer than P75 for phase_3
1 active site
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
Study Start
First participant enrolled
May 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 28, 2010
June 1, 2010
5.3 years
September 12, 2005
June 25, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
TimeLineFollowBack
2 years
Study Arms (3)
TAU
NO INTERVENTIONTelephone Monitoring
ACTIVE COMPARATORTelephone Monitoring and Counseling
EXPERIMENTALInterventions
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.
In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.
Eligibility Criteria
You may qualify if:
- 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;
- th 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James McKay, Ph. D.
University of Pennsylvania
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
May 1, 2004
Primary Completion
August 1, 2009
Study Completion
April 1, 2010
Last Updated
June 28, 2010
Record last verified: 2010-06