Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03233802 |
| Other study ID # |
16-211-3 |
| Secondary ID |
1R01AA024729-01A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2016 |
| Est. completion date |
November 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
UConn Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
