AlcoholismIATP2NCT03233802
Individualized Assessment and Treatment for Alcoholism II
A study testing Individualized Assess & Treatment (IATP), Packaged Cognitive-Behavioral (PCBT) and Case Management (CaseM) in people with Alcoholism, run by UConn Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcoholism
- What is being tested?
- Individualized Assess & Treatment (IATP), Packaged Cognitive-Behavioral (PCBT) and Case Management (CaseM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms
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.
Read the 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.
- Conditions
- Alcoholism
- Being tested
- Individualized Assess & Treatment (IATP), Packaged Cognitive-Behavioral (PCBT), Case Management (CaseM)
- Keywords
- Alcohol Use Disorder, Treatment, Cognitive-Behavioral Treatment, Individualized Treatment
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Assess & Treatment (IATP)Behavioural
See previous description
Packaged Cognitive-Behavioral (PCBT)Behavioural
See previous description
Case Management (CaseM)Behavioural
See previous description
| Study group | Role | What they receive |
|---|---|---|
| Individualized Assess & Treatment (IATP) | Experimental | 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. Receives: Behavioral: Individualized Assess & Treatment (IATP) |
| Packaged Cognitive-Behavioral (PCBT) | Active comparator | 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. Receives: Behavioral: Packaged Cognitive-Behavioral (PCBT) |
| Case Management (CaseM) | Active comparator | 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. Receives: Behavioral: Case Management (CaseM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of days abstinent (PDA)
Proportion of days abstinent in the 90 days prior to each follow-up point
Measured: Every 3 months from intake through 21 months
Secondary outcomes (2)
Proportion Heavy Drinking days (PDH)
Proportion of days in which heavy drinking occurred in the 90 days prior to each follow-up point
Measured: Every 3 months from intake through 21 months
Drinker Inventory of Consequences (DrInC) score
Negative life consequences of drinking
Measured: Every 6 months from intake through 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2017
- Study start1 Aug 2016
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 Group randomized clinical trial with parallel treatments
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Mark Litt, UConn Health
- Investigators
- Mark D Litt, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233802
- Sponsor's protocol ID
- 16-211-3
- Other IDs
- 1R01AA024729-01A1
- Acronym
- IATP2
- Status last verified
- Nov 2022
- First submitted
- 26 Jul 2017
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39374130
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Assessment and Treatment for Alcoholism: Treatment and Mechanisms
- ClinicalTrials.gov ID
- NCT03233802
- Acronym / sponsor ID
- IATP2 / 16-211-3
- Conditions
- Alcoholism
- Keywords
- Alcohol Use Disorder, Treatment, Cognitive-Behavioral Treatment, Individualized Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 31 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- Model description
- 3 Group randomized clinical trial with parallel treatments
| Arm | Type | Receives |
|---|---|---|
| Individualized Assess & Treatment (IATP) | Experimental | Behavioral: Individualized Assess & Treatment (IATP)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. |
| Packaged Cognitive-Behavioral (PCBT) | Active comparator | Behavioral: Packaged Cognitive-Behavioral (PCBT)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. |
| Case Management (CaseM) | Active comparator | Behavioral: Case Management (CaseM)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Assess & Treatment (IATP)See previous description | Behavioural | Individualized Assess & Treatment (IATP) |
| Packaged Cognitive-Behavioral (PCBT)See previous description | Behavioural | Packaged Cognitive-Behavioral (PCBT) |
| Case Management (CaseM)See previous description | Behavioural | Case Management (CaseM) |
Primary outcome
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
2 secondary outcomes
Proportion Heavy Drinking days (PDH)
Time frame: Every 3 months from intake through 21 months
Drinker Inventory of Consequences (DrInC) score
Time frame: Every 6 months from intake through 21 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Derived from this study: PubMed 39374130Litt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D Litt principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Assess & Treatment (IATP), Packaged Cognitive-Behavioral (PCBT) and Case Management (CaseM) in people with Alcoholism, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of days abstinent (PDA) (time frame: Every 3 months from intake through 21 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.