Effectiveness of Extended Telephone Monitoring

NCT ID: NCT00194103

Last Updated: 2010-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2010-04-30

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.

Conditions

Alcohol Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAU

Group Type: NO_INTERVENTION

No interventions assigned to this group

Telephone Monitoring

Group Type: ACTIVE_COMPARATOR

Telephone Monitoring and Feedback

Intervention Type: BEHAVIORAL

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.

Telephone Monitoring and Counseling

Group Type: EXPERIMENTAL

Telephone Monitoring and Counseling

Intervention Type: BEHAVIORAL

In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.

Interventions

Telephone Monitoring and Feedback

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

Telephone Monitoring and Counseling

In addition to attending IOP, participants have phone contact with study counselors, which includes monitoring, feedback, and counseling.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

University of Pennsylvania

Principal Investigators

James McKay, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

R01AA014850

Identifier Type: NIH

Identifier Source: secondary_id

View Link

708753

Identifier Type: -

Identifier Source: org_study_id