Clinical trial NCT03233802: Individualized Assessment and Treatment for Alcoholism II
Official title: Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholism
Keywords: Alcohol Use Disorder
Treatment
Cognitive-Behavioral Treatment
Individualized Treatment
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2017-07-31
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 Group randomized clinical trial with parallel treatments
Primary purpose: TREATMENT

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:

1. 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.
2. 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.

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.

Primary outcomes:
measure: Proportion of days abstinent (PDA)
timeFrame: Every 3 months from intake through 21 months
Secondary outcomes:
measure: Proportion Heavy Drinking days (PDH)
timeFrame: Every 3 months from intake through 21 months
measure: Drinker Inventory of Consequences (DrInC) score
timeFrame: Every 6 months from intake through 21 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UConn Health
state: Connecticut
Study officials:
affiliation: UConn Health
name: Mark D Litt
role: PRINCIPAL_INVESTIGATOR
References: