Combined physical training associated with multidisciplinary intervention in the treatment of alcohol use disorder: a study with n of 1

Pires, Cássio Lamas; Mentz, Lucas Rodrigues; Cardoso, Nicholas Kostopoulos; Sordi, Anne; Figueira, Franciele Ramos; Schuch, Felipe Barreto; Cadore, Eduardo Lusa

doi:10.1590/0047-2085000000416

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Jornal Brasileiro de Psiquiatria

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Brief Communication • J. bras. psiquiatr. 72 (3) • 2023 • https://doi.org/10.1590/0047-2085000000416 copy

Combined physical training associated with multidisciplinary intervention in the treatment of alcohol use disorder: a study with n of 1

O treinamento físico combinado associado à intervenção multiprofissional no tratamento do transtorno por uso de álcool: um estudo com n de 1

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Objective:

Substance misuse can lead to several consequences for physical and mental health. Physical exercise is an important ally to pharmacological and psychotherapeutic treatment for substance use. However, the literature is still scarce regarding long-term interventions. Thus, this study aims to describe the acceptability and effects of combined physical training intervention (aerobic and strength).

Methods:

This study comprises an n-of-1 clinical trial that was performed with a 64-year-old male individual with alcohol use disorder. The treatment lasted 12 weeks and evaluated the association of multidisciplinary interventions on quality of life, depressive symptoms, cognitive impairment, and anxiety.

Results:

The participant improved general quality of life (12.5%), no alterations were found for depressive symptoms, there was an improvement in cognition (20%), as well a reduction in the trait (16.2%) and state (14.7%) anxiety symptoms of the participant.

Conclusions:

These findings allude to the importance of non-drug therapeutic resources such as structured physical exercise, associated with other offers in the treatment of alcohol use disorder.

KEYWORDS:
Alcohol-related disorders; alcoholism; exercise; quality of life; and mental health

Weeks	% HRmáx	% Rep-Max	Volume
1, 2	55-65%	50-55%	2 sets of 15 repetitions
3, 4, 5, 6	65-75%	60-65%	2 sets of 15 repetitions
7, 8, 9, 10	75-80%	70-75%	2 sets of 10 repetitions
11, 12	80-90%	80%	2 sets of 10 repetitions

	General WHOQOL	Physical domain	Psychological domain	Social relations domain	Environmental domain	Self-evaluation Ql	Health satisfaction
Pre	14.76	13.71	14.66	13.33	16.5	14	3
Post	16.61	16.57	16.66	14.66	17.5	16	4
Amplitude	1.85 (+12.5%)	2.86 (+20.8%)	2 (+13.6%)	1.33 (+9.9%)	1 (+6.06%)	2 (+14.2%)	1 (+33.3%)

Section/item	Item Nº	Description
Administrative information
Title	1a	Descriptive title, including “N-of-1 trial” and “protocol”. For series: Descriptive title, including “a series of N-of-1 trials” and “protocol”	OK
	1b	For specific guidance on abstracts, see SPENT Guidance for Abstracts. (Appendix table 2)
Trial registration	2a	Trial identifier and registry name. If not yet registered, name of intended registry	No
Trial registration	2b	All items from the World Health Organization Trial Registration Data Set	No
Protocol version	3	Date and version identifier	OK
Funding	4	Sources and types of financial, material, and other support	OK
Roles and responsibilities	5a	Names, affiliations, and roles of protocol contributors	OK
Roles and responsibilities	5b	Name and contact information for the trial sponsor	Not applicable
	5c	Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities	Not applicable
	5d	Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee)	Not applicable
Introduction
Background and rationale	6a	Description of research question and justification for undertaking the trial, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention, and rationale for using N-of-1.	OK
	6b	Explanation for choice of comparators	OK
Objectives	7	Specific objectives or hypotheses	OK
Trial design	8	Description of the trial design, including N-of-1 trial or series of trials, and framework (eg, superiority, equivalence, non-inferiority, exploratory). In addition for series: Explanation of the series design including whether the design will be tailored to each participant	OK
Methods: Participants, interventions, and outcomes
Study setting	9	Description of study settings (eg, community clinic, academic hospital) and list of countries where data will be collected. Reference to where list of study sites can be obtained	OK
Eligibility criteria	10	Inclusion and exclusion criteria for participants. If applicable, eligibility criteria for study centres and individuals who will perform the interventions (eg, surgeons, psychotherapists). Diagnosis/disorder, diagnostic criteria, co-morbid conditions and concurrent therapies	OK
Interventions	11a	Intervention(s) for each period with sufficient detail to allow replication, including how and when they will be administered, planned number of periods, and duration of each period (including run-in and washout, if applicable).	OK
	11b	Criteria for discontinuing or modifying allocated interventions for a given trial participant (eg, drug dose change in response to harms, participant request, or improving/worsening disease)	Not applicable
	11c	Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests)	OK
	11d	Relevant concomitant care and interventions that are permitted or prohibited during the trial	OK
Outcomes	12	Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended	OK
Participant timeline	13	Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended	Not applicable
Sample size	14	Estimated number of intervention periods and measurements/observations needed to achieve study objectives within an individual N-of-1 trial	Not done
Recruitment	15	Strategies for achieving adequate participant enrolment to reach target sample size	OK
Methods: Assignment of interventions (for controlled trials)
Allocation:
Sequence generation	16a	Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability, details of any restrictions (eg, pairs, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions	Not applicable
Allocation concealment mechanism	16b	Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned	Not applicable
Implementation	16c	Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions	OK
Blinding (masking)	17a	Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how	Not applicable
	17b	If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant’s allocated intervention during the trial	Not applicable
Methods: Data collection, management, and analysis
Data collection methods	18a	Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol	OK
	18b	Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols	Not done
Data management	19	Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol	OK
Statistical methods	20a1	Statistical methods for analyzing primary and secondary outcomes for each individual. Reference to where other details of the statistical analysis plan can be found, if not in the protocol.	OK
	20a2	Statistical methods to account for correlation introduced by the repeated measures and crossover design of N-of-1 studies.	Not applicable
	20b	Methods for any additional analyses (eg, subgroup and adjusted analyses)	Not applicable
	20c	Statistical methods to handle missing data (eg, multiple imputation, modelling)	Not applicable
Methods: Monitoring
Data monitoring	21a	Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed	No
	21b	Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial	No
Harms	22	Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct	No
Auditing	23	Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor	No
Ethics and dissemination
Research ethics approval	24	Plans for seeking research ethics committee/institutional review board (REC/IRB) approval	Ok
Protocol amendments	25	Plans for communicating important protocol modifications (eg, changes to eligibility criteria, outcomes, analyses) to relevant parties (eg, investigators, REC/IRBs, trial participants, trial registries, journals, regulators)	Ok
Consent or assent	26a	Who will obtain informed consent or assent from potential trial participants or authorised surrogates, and how (see Item 32)	Ok
	26b	Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable	Not applicable
Confidentiality	27	How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial	Ok
Declaration of interests	28	Financial and other competing interests for principal investigators for the overall trial and each study site	Ok
Access to data	29	Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators	Ok
Ancillary and post-trial care	30	Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation	Ok
Dissemination policy	31a	Plans for investigators to communicate each individual’s results to the participant. Plans for investigators and sponsor to communicate trial results to participants, health care professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data-sharing arrangements), including any publication restrictions.	Ok
	31b	Authorship eligibility guidelines and any intended use of professional writers	Ok
	31c	Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code	Ok
Appendices
Informed consent materials	32	Model consent form and other related documentation given to participants and authorised surrogates	Ok
Biological specimens	33	Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable	Not applicable

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro Av. Venceslau Brás, 71 Fundos, 22295-140 Rio de Janeiro - RJ Brasil, Tel./Fax: (55 21) 3873-5510 - Rio de Janeiro - RJ - Brazil
E-mail: editora@ipub.ufrj.br

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[1] Address for correspondence: Cássio Lamas Pires. E-mail: cassilhano@gmail.com