Administrative information
Title {1} | Brief motivational therapy versus enhanced usual care for clients with alcohol use disorder in primary care in Chile: study protocol for a pilot randomized trial |
Trial registration {2a and 2b}. | ClinicalTrials.gov, NCT04345302, Registered 28 April 2020, https://clinicaltrials.gov/show/NCT04345302 |
Protocol version {3} | Issue date: 10 April 2020 Protocol version number: 1 |
Funding {4} | The Chilean ‘Fondo Nacional de Desarrollo Científico y Tecnológico’ will fund this study through a research grant (FONDECYT 11190874). The Pontificia Universidad Católica de Chile will provide administrative support. |
Author details {5a} | NB conceived the study. NB and FP developed the first version of the protocol. All authors contributed to refinement of the study protocol and approved the final manuscript. |
Name and contact information for the trial sponsor {5b} | Trial sponsor-investigator: NB Address: Diagonal Paraguay 362, Santiago - Chile. Faculty of Medicine, Pontificia Universidad Católica de Chile. |
Role of sponsor {5c} | The funding agency (FONDECYT) oversees the whole progress of the project through periodic administrative and scientific reports, but has no role in the design, execution, and analysis of this study. |
Introduction
Background and rationale {6a}
Objectives {7}
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Participants under BMT will perform better than EUC in the reduction of alcohol consumption.
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◦ Active BMT components (i.e., the working alliance and fidelity to the MI strategies) mediate the effect.
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◦ Participant’s AUD severity mediates the effect.
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◦ Participants under BMT will receive a higher amount of additional care (physician consultations, social worker consultations, participation in alcoholic anonymous, and others).
Trial design {8}
Methods: participants, interventions, and outcomes
Study setting {9}
Eligibility criteria {10}
Participants
Exclusion criteria
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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.
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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.
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Clients who leave the area or are unable for follow-up contact: Participants who will leave the area before completing the 6 months of follow-up or are unable to provide two alternative contacts.
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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.
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Clients with severe cognitive impairment, illiteracy, or unable to follow treatment in Spanish.
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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.
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Clients who have previously participated in the study or whose family members are or have been participants.
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
BMT
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The translation into Chilean Spanish.
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An update of MI concepts used throughout the manual using the last edition of the MI reference book.
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The addition of companion training material that includes a demonstrative video and practical exercises on the MI strategies.
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A personalized feedback procedure based on the evaluation used in the trial and the local epidemiological situation.
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The addition of information on additional resources available in the PC center and the community to be included in the “menu of options.”
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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 center (i.e., social services, medical services, among others).
Selection and supervision of the providers
Enhancement of usual care
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
Primary outcome
Secondary outcomes
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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 6 months follow-up. Additionally, the most extended period of abstinence since enrolment will be estimated at 6 months follow-up. The number of abstinence days of each participant will be aggregated using means.
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The change from baseline in the negative secondary consequences of alcohol consumption will be measured using the DrInC-2R questionnaire [22] measured at 6 months follow-up and aggregated using means.
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The change from baseline in the severity of the AUD using the Substance Dependence Severity Scale (SDSS) at 6 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.
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The change from baseline in the motivational stage measured with the SOCRATES scale [22] at 6 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
Participant timeline {13}
Sample size {14}
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H0: DDDEUC − DDDBMT = < δ;
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Ha: DDDEUC − DDDBMT > δ.
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
Procedure for unblinding if needed {17b}
Data collection and management
Plans for assessment and collection of outcomes {18a}
Primary outcome
Secondary outcomes
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Outcome | Hypothesis | Outcome measure | Methods of analysis |
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1) Primary | |||
a) Drinks per drinking day at 6 months | BMT reduced outcome from baseline to 6 months | Drinks per drinking day during the last 90 days in the Timeline Follow Back [continuous] | T test |
2) Secondary | |||
a) Alcohol use pattern at 6 months | Back to a low-risk use or abstinence after the treatment | 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] | Chi-squared test |
b) Frequency of heavy drinking at 6 months | Reduction | 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] | T test |
c) Most extended period of abstinence during the last 3 months | Augmentation | Number of days of abstinence within the last 90 days in the Timeline Follow Back [continuous] | T test |
d) Severity of dependency at 6 months | Reduction | Score in the Alcohol DAYS, SEV, and WORST SEV score in the Substance Dependence Severity Scale (last 30 days) [continuous] | T test |
e) Alcohol related negative consequences | Reduction | Total consequences score in the Drinker Inventory of Consequences [continuous] | T test |
3) Subgroup analyses | |||
a) High v/s low severity | Greater effect in low severity. | ||
b) Motivational level | Higher motivation intensifies the treatment effect. | ||
c) Educational level | Higher education intensifies the treatment effect. | ||
d) Male v/s female | Sex interacts with treatment effect. | ||
4) Sensitivity analyses | |||
a) Per-protocol analysis | a) T test/chi-squared | ||
b) Adjustment for baseline variables | b) Linear model (multivariate regression) | ||
c) Missing data imputation | c) Multiple imputation (missing-at-random assumption) |