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Individualized Assessment and Treatment for Alcoholism II (IATP2)

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Individualized Assess & Treatment (IATP)
Packaged Cognitive-Behavioral (PCBT)
Case Management (CaseM)
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism focused on measuring Alcohol Use Disorder, Treatment, Cognitive-Behavioral Treatment, Individualized Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be at least 18 years old,
  • Meet DSM-V criteria for Alcohol Use Disorder moderate-severe
  • Willing to accept random assignment to any of the three conditions

Exclusion Criteria:

  • Acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk)
  • Reading ability below the fifth grade level
  • Lack of reliable transportation to the treatment site, or excessive commuting distance.

Sites / Locations

  • UConn Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Individualized Assess & Treatment (IATP)

Packaged Cognitive-Behavioral (PCBT)

Case Management (CaseM)

Arm Description

Intervention: Cognitive-Behavioral IATP consists of 12 weekly visits of individual treatment. IATP employs cellphone-based experience sampling via interactive voice response (IVR) to assess drinking, plus craving, thoughts, feelings, and coping behaviors to develop near a real-time picture of patients' high-risk situations and the ways they use to deal with them. This information will be used by the therapist and client together to problem-solve and devise adaptive coping responses to these specific high-risk situations, and develop generalized solutions to deal with other situations in the future.

Intervention: Cognitive-Behavioral PCBT consists of 12 weekly visits of individual treatment. PCBT is designed to remediate deficits in skills for coping with interpersonal (e.g., social pressure, conflict with others) and intrapersonal (e.g., craving, anger) antecedents to drinking. The treatment consists of 6 mandatory modules (e.g., managing cravings) plus 6 electives from a list of 10 (e.g., receiving criticism; scheduling pleasant activities).The treatment, based on manuals developed for our previous clinical research provides a structured experience using didactic presentations, behavioral rehearsal, and homework practice exercises.

Intervention: Social and Instrumental Support CaseM is included to control for cohort and other common factors in treatment. During the 12 individual CaseM sessions the therapist and participant will identify problems in daily living that may be of concern, and consider community resources that might help in dealing with them (e.g., contacting a psychiatrist for depression, or finding a better place to live). The therapist's role is to explore the patient's concerns, help to identify goals and resources, provide verbal support, and troubleshoot difficulties that may arise in obtaining or following through with services. The support and attention to ancillary services has proven effective in reducing drinking in previous studies.

Outcomes

Primary Outcome Measures

Proportion of days abstinent (PDA)
Proportion of days abstinent in the 90 days prior to each follow-up point

Secondary Outcome Measures

Proportion Heavy Drinking days (PDH)
Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point
Drinker Inventory of Consequences (DrInC) score
Negative life consequences of drinking

Full Information

First Posted
July 26, 2017
Last Updated
November 16, 2022
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03233802
Brief Title
Individualized Assessment and Treatment for Alcoholism II
Acronym
IATP2
Official Title
Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The object of this study is to develop a treatment for alcohol use disorders that is more effective than current CB treatments. Through a 2009 R-21 pilot project the investigators developed a cognitive-behavioral (CB) treatment that employed cellphone-based experience sampling (ES) to collect detailed patient data, in near real-time, and that used those data to direct treatment for each patient based on his/her pattern of drinking and specific coping actions during high-risk situations. ES data included momentary assessments of situations, thoughts and feelings antecedent to drinking episodes, and the use of coping skills. That initial study of the Individualized Assessment and Treatment Program (IATP) showed promise. The present study is intended to extend the earlier findings, to compare IATP to a more active control treatment, and to evaluate long-term outcomes.
Detailed Description
An 2009 R-21 pilot project developed a cognitive-behavioral treatment for alcohol use disorders that employs cellphone-based experience sampling (ES) to collect detailed patient data in near real-time, and uses those data to direct treatment for each patient based on his/her specific patterns of drinking and specific coping actions during actual high-risk situations. ES data included situations, thoughts and feelings antecedent to drinking episodes, and any use of coping skills. The object was to create a CB treatment that was more relevant for each patient and more effective than current treatments. In the initial study the Individualized Assessment and Treatment Program (IATP) yielded better drinking rates at posttreatment, and more adaptive changes in coping, than a conventional manualized CBT program. Moreover, changes in drinking were partly mediated by pre-to-posttreatment changes in coping with high-risk situations. Questions unanswered included: Because the pilot study only collected data pre- and posttreatment, with no follow-ups, it is not clear whether use of coping skills reduced drinking, or whether reduced drinking led to more adaptive coping. It was not known which coping skills or other factors drive outcomes in the long-term. To answer these and other questions the investigators proposed to enroll 207 patients in a full-scale trial of IATP with extended follow-ups to examine determinants of outcomes over time. IATP will be compared to a more conventional packaged CB treatment (PCBT), and to a Case Management Control condition (CaseM), in a dismantling design. In addition to coping, a number of other possible treatment mechanisms suggested by the literature will be examined, including motivation, self-efficacy, self-control, social support, alliance with the therapist, AA involvement, mindfulness, and utilization of other treatment services. By specifically training coping skills for use in high-risk for drinking situations, the investigators will be able to assess how skills per se contribute to initiation and long-term maintenance of behavior change. The use of ES during treatment will allow a determination of what patients are actually doing, in close to real time, to initiate and maintain their own sobriety. The use of ES in the follow-up period will allow the investigators to determine whether coping skills that were active in initiation of reduced drinking continue to be active in the long-term, as well as the extent to which other mechanisms may come into play. In this way investigators can develop a clearer picture of the processes that affect outcomes of CBT, and will enable clinicians to focus more precisely on the most relevant mechanisms of change. Comparing IATP with PCBT will test effects of tailoring skills. The use of CaseM will control for the general effects of study participation (i.e., "common factors"), especially therapist support. The study builds on pilot data and on procedures that have already been developed but not fully tested. This would be the first study to evaluate effects of treatment on actual behaviors and cognitions in high-risk situations as they occur.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol Use Disorder, Treatment, Cognitive-Behavioral Treatment, Individualized Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 Group randomized clinical trial with parallel treatments
Masking
Investigator
Masking Description
Investigators are blind to treatment conditions
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized Assess & Treatment (IATP)
Arm Type
Experimental
Arm Description
Intervention: Cognitive-Behavioral IATP consists of 12 weekly visits of individual treatment. IATP employs cellphone-based experience sampling via interactive voice response (IVR) to assess drinking, plus craving, thoughts, feelings, and coping behaviors to develop near a real-time picture of patients' high-risk situations and the ways they use to deal with them. This information will be used by the therapist and client together to problem-solve and devise adaptive coping responses to these specific high-risk situations, and develop generalized solutions to deal with other situations in the future.
Arm Title
Packaged Cognitive-Behavioral (PCBT)
Arm Type
Active Comparator
Arm Description
Intervention: Cognitive-Behavioral PCBT consists of 12 weekly visits of individual treatment. PCBT is designed to remediate deficits in skills for coping with interpersonal (e.g., social pressure, conflict with others) and intrapersonal (e.g., craving, anger) antecedents to drinking. The treatment consists of 6 mandatory modules (e.g., managing cravings) plus 6 electives from a list of 10 (e.g., receiving criticism; scheduling pleasant activities).The treatment, based on manuals developed for our previous clinical research provides a structured experience using didactic presentations, behavioral rehearsal, and homework practice exercises.
Arm Title
Case Management (CaseM)
Arm Type
Active Comparator
Arm Description
Intervention: Social and Instrumental Support CaseM is included to control for cohort and other common factors in treatment. During the 12 individual CaseM sessions the therapist and participant will identify problems in daily living that may be of concern, and consider community resources that might help in dealing with them (e.g., contacting a psychiatrist for depression, or finding a better place to live). The therapist's role is to explore the patient's concerns, help to identify goals and resources, provide verbal support, and troubleshoot difficulties that may arise in obtaining or following through with services. The support and attention to ancillary services has proven effective in reducing drinking in previous studies.
Intervention Type
Behavioral
Intervention Name(s)
Individualized Assess & Treatment (IATP)
Intervention Description
See previous description
Intervention Type
Behavioral
Intervention Name(s)
Packaged Cognitive-Behavioral (PCBT)
Intervention Description
See previous description
Intervention Type
Behavioral
Intervention Name(s)
Case Management (CaseM)
Intervention Description
See previous description
Primary Outcome Measure Information:
Title
Proportion of days abstinent (PDA)
Description
Proportion of days abstinent in the 90 days prior to each follow-up point
Time Frame
Every 3 months from intake through 21 months
Secondary Outcome Measure Information:
Title
Proportion Heavy Drinking days (PDH)
Description
Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point
Time Frame
Every 3 months from intake through 21 months
Title
Drinker Inventory of Consequences (DrInC) score
Description
Negative life consequences of drinking
Time Frame
Every 6 months from intake through 21 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be at least 18 years old, Meet DSM-V criteria for Alcohol Use Disorder moderate-severe Willing to accept random assignment to any of the three conditions Exclusion Criteria: Acute medical or psychiatric problems that require inpatient treatment (e.g., acute psychosis, or suicide/homicide risk) Reading ability below the fifth grade level Lack of reliable transportation to the treatment site, or excessive commuting distance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark D Litt
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Individualized Assessment and Treatment for Alcoholism II

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