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Completed

NCT Number: NCT03233802

Individualized Assessment and Treatment for Alcoholism II

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UConn Health

Farmington, Connecticut, 06030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized Assess & Treatment (IATP)

Behavioral

See previous description

Packaged Cognitive-Behavioral (PCBT)

Behavioral

See previous description

Case Management (CaseM)

Behavioral

See previous description

Primary outcomes

  1. Proportion of days abstinent (PDA)

    Time frame: Every 3 months from intake through 21 months

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

Secondary outcomes

  1. Proportion Heavy Drinking days (PDH)

    Time frame: Every 3 months from intake through 21 months

    Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point

  2. Drinker Inventory of Consequences (DrInC) score

    Time frame: Every 6 months from intake through 21 months

    Negative life consequences of drinking

Sponsors and collaborators

Lead sponsor

UConn Health

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms

Acronym: IATP2

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 31, 2017
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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