Individualized Assessment and Treatment for Alcoholism II
IATP2
2 other identifiers
interventional
173
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedNovember 17, 2022
November 1, 2022
6.3 years
July 26, 2017
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of days abstinent (PDA)
Proportion of days abstinent in the 90 days prior to each follow-up point
Every 3 months from intake through 21 months
Secondary Outcomes (2)
Proportion Heavy Drinking days (PDH)
Every 3 months from intake through 21 months
Drinker Inventory of Consequences (DrInC) score
Every 6 months from intake through 21 months
Study Arms (3)
Individualized Assess & Treatment (IATP)
EXPERIMENTALIntervention: 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.
Packaged Cognitive-Behavioral (PCBT)
ACTIVE COMPARATORIntervention: 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.
Case Management (CaseM)
ACTIVE COMPARATORIntervention: 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.
Interventions
See previous description
See previous description
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UConn Health
Farmington, Connecticut, 06030, United States
Related Publications (1)
Litt MD, Tennen H, Kadden RM. Individualized Assessment and Treatment Program (IATP) for alcohol use disorder: Comparison with conventional cognitive-behavioral treatment and examination of coping skills as a mediator of treatment. J Consult Clin Psychol. 2024 Oct;92(10):711-726. doi: 10.1037/ccp0000907. Epub 2024 Oct 7.
PMID: 39374130DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark D Litt
UConn Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- Investigators are blind to treatment conditions
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Behavioral Sciences
Study Record Dates
First Submitted
July 26, 2017
First Posted
July 31, 2017
Study Start
August 1, 2016
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
November 17, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share