Participants, interventions and outcomes
Study setting {9}
The trial will take place in PC centres in Santiago, Chile.
Eligibility criteria {10}
Participants:
The protocol captures typical PC clients to maximize external validity. Hence, participants will be recruited from the SBIRT program currently conducted in PC centres, as well as from physician referrals. Our inclusion criteria follow previous robust clinical trials to enhance comparability (the project MATCH[13] and the UKATT study[14]).
Any client with an Alcohol Use Disorders Identification Test (AUDIT) > 15 will be considered for eligibility. We will include clients who fulfil criteria for alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders V[18] (DSM-V), and criteria for harmful alcohol use during the last month, i.e., five or more heavy drinking occasions in the last month (5 or more drinks in men, 4 or more in women), or an average use of 14 or more drinks a week in men, and 7 or more in women. Also, alcohol use should be the main problem motivating participants to seek treatment. In case of doubts about the eligibility of a potential participant, the criterion to follow is whether this individual would be offered treatment in PC under normal conditions.
Additionally, a clinician will verify the need to refer the participant to a detoxification service before enrolment into the trial, as well as referrals to address any pressing issue (i.e., homelessness, unstable medical pathology, developing legal situation, and so forth).
The participation of a significant other that can help the client through the treatment will be encouraged from the beginning.
Exclusion criteria
- Clients under 20 years old: In Chile, younger clients attend specific providers under a specific administrative regimen (the Explicit Health Guarantees system). Therefore, regulatory restrictions preclude the recruitment of participants under age 20.
- Clients in whom alcohol use is not the main problem: Following the methodology of the UKATT study[14], clients with a problematic consumption of other substances (e.g., marijuana, cocaine) may participate in the trial, provided that alcohol is currently their primary source of problems. Given that the UKATT study demonstrated effectiveness in people with more than one substance use disorder, we will follow that approach to include clients as they exist in the real world.
- Clients who leave the area or are unable for follow-up contact: Participants who will leave the area before completing the six months of follow-up, or are unable to provide two alternative contacts.
- Clients with severe mental comorbidity: Clients with psychotic disorders, schizophrenia, active suicidal ideation, who currently represent a risk of aggression towards themselves or towards third parties, impulse control disorders, or who have any other severe mental disorder. In this regard, we are following a restrictive exclusion criterion, similar to that of the MATCH project[13]. Additionally, these clients are not treated in PC.
- Clients with severe cognitive impairment, illiteracy, or unable to follow treatment in Spanish.
- Clients who are concurrently receiving or planning to receive other psychosocial treatment for AUD other than EUC, i.e., formal professional treatment outside of PC. Participation in community services and Alcoholics Anonymous is permissible.
- Clients who have previously participated in the study, or whose family members are or have been participants.
Who will take informed consent? {26a}
A certified clinician in the role of research assistant (RA) will take informed consent after confirming participant eligibility. The informed consent will be taken in person, at each clinical site.
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Participants will be asked for consent to use their anonymized data in scientific publications. No biological specimens will be collected in this trial.
Interventions
Explanation for the choice of comparators {6b}
To study the effect of the BMT in PC, we will compare it with usual care as it occurs in Chilean PC. This comparator is relevant since it acknowledges the pragmatic goal of this trial: whether Chilean PC should incorporate this treatment among its regular programs based on its effectiveness.
Although this comparator is appropriate for the research question, its usage raises some problems. The main issue we foresee is a high variability of the services that constitute usual care between different clients and across different PC centres. The services could range from a delay in treatment due to a lengthy waiting list, to multiple timely interventions provided by an organized psychosocial team. In an extreme scenario, if this heterogeneity is too high, it could complicate the statistical analysis.
However, in the real-world scenario where the study will take place, we think it is reasonable to compare BMT against EUC. Based on local data, we assume that over 80% of AUD cases will be waiting for a consultation in the specialized services, and, in the meantime, receiving a low level of non-specific services in PC. Thus, these cases compose a homogeneous cohort where we expect the typical evolution of AUD within PC. It is still possible that a proportion of these clients will receive some treatment modality (not BMT) or present spontaneous remission, so we are taking this fact into account for sample size calculation.
Intervention description {11a}
A. BMT:
Participants in the intervention group will receive the BMT, which is a PC-adaptation of the MET as manualized in the Project MATCH[19]. This treatment consists of four 45-minute sessions, provided by a psychologist at weeks one, two, six, and twelve. The first three sessions, occurring during the first six weeks, are more active regarding the behavioural change, while the last session functions as closure and review of the process. If a participant asks for more support, they will be able to attend up to two extra sessions before the last one.
The main adaptations to the original Project MET manual are:
- The translation into Chilean Spanish.
- An update of MI concepts used throughout the manual using the last edition of the MI reference book.
- The addition of companion training material that includes a demonstrative video and practical exercises on the MI strategies.
- A personalized feedback procedure based on the evaluation used in the trial and the local epidemiological situation.
- The addition of information on additional resources available in the PC centre and the community to be included in the 'menu of options'
- The addition of a module regarding the coordination of health services in the Chilean PC context. This supplementary material is meant to facilitate the participants´ access to services complementary to BMT within the PC centre (i.e., social services, medical services, among others)
B. Selection and supervision of the providers:
We will recruit general psychologists or other psychosocial professionals with at least three years of experience in PC. They will receive training in BMT and then will demonstrate proficiency in a simulated client session (or will provide a taped interview showing a proficient application of BMT).
During recruitment, therapy sessions will be recorded, and ten percent of them will be reviewed using an MI proficiency scale. Then, a feedback report on the fidelity to MI will be issued and discussed with each therapist. The instrument to be used will be chosen during the pilot among the available validated tools[20].
C. Enhancement of usual care:
All participants will receive an educational brochure on alcohol use disorder, with self-help materials and guides on how to get additional support.
The physicians within the PC centre will also receive information on how to diagnose AUD, prescription guides for the medications that are available for treating these disorders in the PC centre (mainly Disulfiram and any other if available), and directions on when and where to refer clients for treatment.
Criteria for discontinuing or modifying allocated interventions {11b}
As the BMT will be added to EUC, all participants will be receiving the current standard of care in Chile. Also, psychosocial treatments based on MI are not expected to induce severe adverse events.
Strategies to improve adherence to interventions {11c}
Before each session, the participants will receive a confirmation call. They will additionally receive public transportation vouchers for their attendance to assessments.
Relevant concomitant care permitted or prohibited during the trial {11d}
During the trial, participants will continue to receive regular medical and social care at their health centre. These services may include prescriptions for mental health issues and alcohol (Disulfiram, anti-craving, anti-depressants, and other medications), social assistance, and the full spectrum of primary health care. Nevertheless, they will not receive other psychosocial interventions for AUD in the health centre.
Additionally, participants are asked not to initiate other formal psychosocial treatment for alcohol use disorder until trial termination. This restriction does not include non-professional community services, such as attendance to Alcoholics Anonymous or other informal support.
The study record will keep track of the days when a participant receives additional treatment (if any). Even though it is prohibited, a participant that eventually receives additional formal psychosocial treatment for AUD will continue to receive the allocated treatment, will complete follow-up, and their data will be included to be analysed according to the original allocation group.
Provisions for post-trial care {30}
Once the trial has finished, the participants will continue their usual health care at their PC centres. There will not be special post-trial care.
Outcomes {12}
Primary outcome:
The change from baseline in the Drinks per Drinking Day (DDD) during the last 90 days (i.e., the previous 12 weeks), measured at six-months follow-up. The DDD will be aggregated using means.
The DDD constitutes a relevant outcome because the frequency and quantity in which alcohol is consumed mediate the occurrence of behavioural disorders and health deterioration in clients with AUD. Even though a more comprehensive result, such as clinical recovery or improved quality of life, would be of more clinical significance, these outcomes exceed a short-term, exploratory trial. We have chosen DDD because it has shown to be sensitive to treatment and because it allows comparability with influential clinical trials[21].
Secondary outcomes:
- The number of participants with a low-risk alcohol use pattern estimated by the number of days of consumption, of abstinence, and intoxication during the last 90 days, aggregated using the proportion of participants per group, at six-months follow-up. Additionally, the most extended period of abstinence since enrolment will be estimated at six-months follow-up. The number of abstinence days of each participant will be aggregated using means.
- The change from baseline in the negative secondary consequences of alcohol consumption will be measured using the DrInC-2R questionnaire[22] measured at six-months follow-up, and aggregated using means.
- The change from baseline in the severity of the AUD using the Substance Dependence Severity Scale (SDSS) at six-months follow-up[23]. Means will be used to aggregate participants` DAYS, SEV, and WORST SEV scores for alcohol. The severity of AUD is a critical outcome in two ways: first, we hypothesize that the severity should decrease with treatment; second, severity is expected to predict treatment effect, so it could help identify a specific range of severity in which BMT is more effective.
- The change from baseline in the motivational stage measured with the SOCRATES scale[22] at six-months follow-up. The proportion of participants that improve their motivational stage will be used to aggregate the measurement in each group. This scale was designed to classify clients in one of the stages of change according to Prochaska and DiClemente[24], and is expected to mediate client recovery and predict treatment effect.
Other instruments:
The therapeutic alliance will be measured after each treatment session (four times during the trial) using the Working Alliance Inventory short form in its client and therapist versions (WAI-C and WAI-T)[25].
Finally, we will collect baseline demographic variables (age, sex, years of education, employment status, and marital status).
Participant timeline {13}
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STUDY PERIOD
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Enrolment
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Allocation
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Post-allocation (months)
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Close-out
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TIMEPOINT
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0
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m1
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m2
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m3
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m6
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ENROLMENT:
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Eligibility screen
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X
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Informed consent
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X
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Allocation
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X
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INTERVENTIONS:
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Brief motivational treatment
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——————
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Enhanced Usual Care
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——————
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ASSESSMENTS:
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Timeline Follow-back
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X
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X
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SDSS
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X
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X
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DSM V diagnose
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X
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Other treatment records
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X
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X
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DrInC-2R
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X
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X
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SOCRATES
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X
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X
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WAI – C and T
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X
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X
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X
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X
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Demographic variables
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X
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Sample size {14}
Given that there is a spontaneous reduction of alcohol consumption in control groups of 14%[26], and that the reduction attributed to psychosocial treatments in the literature is around 40%[27], we set a superiority margin d of 26% reduction in alcohol consumption. The following two hypotheses correspond to the superiority test:
We used local data and the results of project MATCH as references for sample size calculation. Project MATCH[13] recruited participants with AUD in the outpatient setting and observed a standard deviation (SD) of 6.29 drinks, which is similar to reports in Chilean PC[28]. On admission, participants in the MATCH study consumed 11.5 DDD, which should be similar in our population. We expect a decrease of 14% in the EUC group[26], that is to 9.89 DDD; and a reduction to 40% in the intervention group[27,29] that is, a decrease to 6.9 DDD.
The sample size was obtained using the formula for means comparison in superiority studies of parallel groups, according to the methodology described by Chow[30]. The computation was made using the R statistical software[31] with the package provided by the same author[30][32]. We obtained a sample size of n1 = n2 = 76 using the following parameters: . (where is the type 1 error, [1-] the power, the standard deviation, the expected difference between both groups, and the allocation ratio between both groups)
Considering an expected loss to follow-up of 20%, we will have to recruit 91 participants for each group, which is 182 participants in total.
Recruitment {15}
The SBIRT program will be the primary recruitment source. Annually, this program detects roughly 60 people looking for treatment for AUD in each PC centre. Working in close coordination with the local SBIRT program administrator, an RA will contact these individuals and invite them to participate in the study. Also, the clinical staff in the centre will be able to refer potential participants to the study.
In case participant enrolment is slow, we will advertise the study in the community.
Assignment of interventions: allocation
Sequence generation {16a}
Participants will be randomly assigned to either control or experimental group with 1:1 allocation as per a computer-generated randomisation schedule stratified by site and the baseline SDSS-DAYS score using permuted blocks of random sizes. The cut point for the severity score will be determined during the trial pilot. To ensure concealment, we specified the block sizes in a separate document with restricted access.
Concealment mechanism {16b}
An online, central randomisation service will randomise the participants to either group. This service assures concealment since it only reveals the sequence after the completion of baseline measurements and the confirmation of eligibility.
Implementation {16c}
During the intake visit, an RA will first administer the baseline measurements, then check the inclusion/exclusion criteria, and finally, ask the central randomisation service to assign the participant. The RA will use an online platform to complete the assessments and the randomisation.
Assignment of interventions: Blinding
Who will be blinded {17a}
An RA blinded to the allocation of the participant will perform the follow-up assessments. Due to the nature of the intervention, the participants and the therapists will know in which group they are participating; however, they will be strongly instructed to not disclose their allocation at the follow-up assessments. At trial closure, a statistician blinded to allocation will conduct the data analysis.
Procedure for unblinding if needed {17b}
Not applicable since both participants and therapists are not blinded, and any undesired effects of the intervention will be managed without the need for unblinding.
Data collection and management
Plans for assessment and collection of outcomes {18a}
Primary outcome:
The DDD during the last 90 days will be obtained using the Timeline Follow Back[33](TLFB) procedure. The TLFB uses a calendar with key dates as memory aids to enhance recall. This method will also record other treatments that the participants received and capture the alcohol use pattern, which is defined as the typical number of drinks consumed in a drinking occasion in the previous 90 days, the frequency of heavy drinking days during the last 90 days (> 4 standard drinks in women and > 5 in men), and the total number of standard drinks consumed in a week during the last 90 days. The reliability of these measurements using TLFB lies between 0.7 to 0.9[33].
Secondary outcomes:
Substance Dependence Severity Scale (SDSS) (Spanish version)[23]. This instrument measures the severity of the dependence linked to the DSM-V diagnostic criteria by assessing both the frequency and severity of symptoms during the last 30 days. The DAYS score varies on an 8-point scale ranging from 0 (symptom did not occur) to 7 (symptom occurred every day of past 30). The SEV and WORST SEV severity variables are scored on a 6-point scale ranging from 0 (absent) to 5 (extreme), with a score of '2' indicating that the diagnostic criterion has been met. Lower scales scores represent less severe dependence, and higher scale scores reflect more severe dependence. This scale is reliable and sensitive to change in the context of addiction treatments. Additionally, the scale has a good correlation with other severity measurements, such as the Addiction Severity Index (ASI), the Drinker Inventory of Consequences (DrInC), and the Global Assessment Scale[34]. Its test-retest reliability for alcohol is excellent: ICC 0.90 [0.79 - 0.88] for severity and ICC 0.82 [0.77 - 0.86]. The reliability and concurrent validity of the Spanish version have also been studied and behave very similarly to the original scale[35]. The RAs will be trained on the procedures to apply this instrument according to what has been reported by the authors.
Drinker Inventory of Consequences (DrInC-2R): This inventory addresses the negative consequences of alcohol abuse during the last three months using five sub-scales: physical, interpersonal, intrapersonal, social responsibility, and impulse control. Its global score ranges from 0 to 150, with higher scores indicating higher consequences. The test-retest reliability for total consequences is 0.88 (ICC), and the sub-scales range from 0.69 to 0.92 (ICC)[36]. Even though the reduction of repercussions is at the heart of treatment objectives, we did not choose it as the primary outcome because it is harder to measure and less sensitive in the short-term. This inventory will be completed by the participant with the supervision and assistance of the RAs.
SOCRATES: This 19-item scale measures the motivation in a continuum of three main sub-scales [taking-steps (score range 8 - 40), recognition (7 – 35), and ambivalence (4-20)] that explain 45% of the variance and have good internal consistency (Cronbach´s alphas between 0.87 and 0.96), with excellent test-retest properties (interclass correlations ranged from 0.82 to 0.94)[37]. This scale will be completed by the participant with the supervision and assistance of the RAs.
Outcome adjudicators: In this study, the RAs will be a small group of health professionals (i.e., nurses, psychologists, or social workers) who have experience in mental health in PC, and who will complete a training program to standardize data collection procedures and ensure the skilful application of the psychometric instruments according to the test manuals.
Plans to promote participant retention and complete follow-up {18b}
To minimize participant´s burden in the process of data collection, they will receive economic compensation for attending the two follow-up sessions. Furthermore, to reduce attrition and maximize completeness of data, we have put special care in keeping the data to the minimum necessary for the trial objectives.
To encourage attendance to therapy and follow-up sessions, a centralized appointment and reminder system will contact the participants in advance.
Despite these strategies, it is anticipated that some participants will not adhere to the follow-up schedule, the therapeutic scheme, or other crucial aspects of the protocol; however, we will include all participants in the analysis to be consistent with an intention-to-treat approach.
Data management {19}
In this trial, all data will be entered electronically at the site where data originated using a tablet computer. Customary verification algorithms will ensure completeness and validity at the moment of data entry. There will not be any paper copies of the psychometric instruments or the demographic data forms other than what is required for the treatment sessions (i.e., structured feedback). These procedures avoid data transcription and ensure the integrity from the moment of collection. The database will be stored in a private server and will be backed-up weekly.
Confidentiality {27}
Data will be anonymized to ensure confidentiality through a unique participant number that will link the electronic data with the participant's identification. The informed consent document will be the only record containing both the identification number and the participant's personal information. This document will be stored in a secure place at each site and transferred monthly to the central coordinating centre, where it will be stored for five years after study closure. A formal presentation to the Ethics committee is necessary to access these documents.
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Not applicable as no biological specimens will be collected as part of this trial.
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
We will compare the BMT group with the EUC group for every main outcome listed in Table below. T-tests will compare continuous results, and Chi-squared tests will compare dichotomous outcomes. We will compute Mean Differences (MD) for continuous outcomes, and Relative Risks (RR) and RR reductions (RRR) for dichotomous results, with their corresponding 95% confidence interval. P-values will be reported to four decimal places, with p-values less than 0.001 reported as <0.001. The latest version of R[31] will be used to perform the statistics. Table 1 summarizes the methods for the analysis of each outcome.
Table 1 Statistical methods for outcomes and ancillary analyses
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Outcome
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Hypothesis
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Outcome measure
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Methods of analysis
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1) Primary
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a) Drinks per Drinking Day at six months
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BMT reduced outcome from baseline to 6 months
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Drinks per Drinking Day during the last 90 days in the Timeline Follow Back [continuous]
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T-test
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2) Secondary
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a) Alcohol use pattern at six months
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Back to a low-risk use or abstinence after the treatment
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Presence of a low-risk pattern: less than 100 g of ethanol a week and no binge drinking occasions (i.e., more than three SD in women and 4 in men) during the last 90 days in the Timeline Follow Back [binary]
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Chi-squared test
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b) Frequency of heavy drinking at six months
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Reduction
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Number of heavy drinking occasions (i.e., more than three SD in women and more than four in men) during the last 90 days in the Timeline Follow Back [continuous]
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T-test
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c) Most extended period of abstinence during the last three months
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Augmentation
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Number of days of abstinence within the last 90 days in the Timeline Follow Back [continuous]
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T-test
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d) Severity of dependency at six months
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Reduction
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Score in the Alcohol DAYS, SEV, and WORST SEV score in the Substance Dependence Severity Scale (last 30 days) [continuous]
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T-test
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e) Alcohol related negative consequences
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Reduction
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Total consequences score in the Drinker Inventory of Consequences [continuous]
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T-test
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3) Subgroup analyses
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a) High v/s Low severity
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Greater effect in low severity.
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b) Motivational level
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Higher motivation intensifies the treatment effect.
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c) Educational level
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Higher education intensifies the treatment effect.
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d) Male v/s Female
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Sex interacts with treatment effect.
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4) Sensitivity analyses
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a) Per-protocol analysis
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a) T-test / Chi-squared
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b) Adjustment for baseline variables
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b) Linear model (multivariate regression)
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c) Missing data imputation
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c) Multiple imputation (missing-at-random assumption)
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Interim analyses {21b}
Not applicable. We do not expect that this intervention added to usual care increases the rate of adverse events or complications. On the other hand, the recruitment rate and sample size make interim analyses impractical.
Methods for additional analyses (e.g. subgroup analyses) {20b}
Linear models with the appropriate interaction factors will deliver the subgroup analyses. We will examine the residuals to check for model assumptions and common problems with the errors, the predictors, and the model structure. If necessary, robust regression methods or transformations will be used.
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
For the analysis of missing data, we will follow the missing-at-random assumption, which allows valid analysis independently of the missing value mechanism. We assume, therefore, that missingness is associated with the baseline alcohol use pattern after conditioning on covariates, which is a reasonable assumption since higher alcohol usage leads to treatment failure and reduced follow-up. In this scenario, we will use a multiple imputation method to handle missing data.
On the other hand, to prevent attrition bias, outcome data from all randomized participants will be analysed according to the group they were allocated, regardless of protocol adherence.
Plans to give access to the full protocol, participant level-data and statistical code {31c}
The full protocol, dataset, and statistical code are available in the Open Science Foundation repository, DOI 10.17605/OSF.IO/6BA3W
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
This trial will be conducted and monitored by a small research team made up of the authors and the support staff. This team includes a person with data management training who will oversee data collection and integrity, and a general coordinator to handle daily operations at the sites.
Composition of the data monitoring committee, its role and reporting structure {21a}
Not applicable. This trial is of relatively short duration and presents minimal risks for participants since BMT is not known to have adverse effects on clients. Any typical emergency situations will be managed as usual in the health care context. For these reasons, it seems unnecessary to have a formal data-monitoring committee (i.e., a multidisciplinary group of people independent from the trial researchers that decide on trial modification or suspension).
Adverse event reporting and harms {22}
The brief motivational therapy is not supposed to increase health risks in clients; however, due to the behavioural nature of the alcohol use disorder, it is expected that some common problems could arise in the participants. High-risk events, such as suicidal ideation or behaviour, violence and aggression to others, increase in depressive symptoms or anxiety, severe intoxication, or withdrawal symptoms, will all be managed with a crisis intervention delivered in the health centre in accordance with local protocols. Close coordination between the study therapists and the rest of the health team will be encouraged through all protocol execution so that crisis protocols can be activated when necessary.
The study therapists will be responsible for assessing the participant when an adverse event is suspected, and if confirmed, will contact the trial coordinator and the local organization to mobilize the required resources (e.g., medical assessment, referral to the emergency room, contact to a family member, etc.). The participants will have access to a centralized phone number where they can contact their therapist for help in case of emergency issues regarding treatment.
The trial coordinator will complete a report with the details of the event, including the diagnose, management, and harms to the participant.
Frequency and plans for auditing trial conduct {23}
There are two main areas where periodic audit procedures will take place: the clinical interaction among clients and therapists, and data integrity. All the therapy sessions will be audio-recorded, then ten percent of those will be randomly analysed to check intervention fidelity. Also, by the end of each session, the client will report on the therapeutic alliance using a validated tool. Both procedures are meant to control the quality of the interventions being provided. Regarding data integrity, a research assistant with training in data supervision will verify the consistency and completeness of data each month.
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}
Any significant change to the protocol will require a formal amendment presentation to the ethics committee of the Pontificia Universidad Católica de Chile. Such amendments include, among others, changes to the primary outcome, sample size calculations, eligibility criteria, methods for blinding and allocation concealment, and statistical analysis.
Dissemination plans {31a}
This trial originated from the collaborative work between our research team and the National Agency for Alcohol and Drugs (SENDA, its Spanish acronym). Additionally, the local primary care health services are providing critical support to the study. This proximity between our research team and the stakeholders should make dissemination easy, especially for the local context. In this regard, we will hold regular meetings with local stakeholders throughout the study, and at least one meeting with SENDA to share the results at the end of the study.
Furthermore, as the results may be of interest to other PC services that address alcohol use disorders, we will publish the results in an international journal. The goal is to have the main manuscript submitted within one year from trial closure.