RESUMO
BACKGROUND: Substance use disorders show a high comorbidity with externalizing behavior difficulties, creating treatment challenges, including difficulties with compliance, a high risk of conflict, and a high rate of offending post-treatment. Compared with people with other substance use disorders those with opioid use disorders have the highest risk of criminal activity, but studies on the evidence base for psychosocial treatment in opioid agonist treatment (OAT) are scarce. The Impulsive Lifestyle Counselling (ILC) program may be associated with better retention and outcomes among difficult-to-treat patients with this comorbidity. METHODS: The study is a multicenter, randomized, controlled, superiority clinical trial. Participants will be a total of 137 hard-to-treat individuals enrolled in opioid agonist treatment (OAT). Participants will be randomized to either a standard treatment (14 sessions of individual manual-based cognitive behavioral therapy and motivational interviewing (MOVE-I)) or six sessions of ILC followed by nine sessions of MOVE-I. All participants will receive personalized text reminders prior to each session and vouchers for attendance, as well as medication as needed. The primary outcome is retention in treatment. Secondary measures include severity of drug use and days of criminal offending for profit three and nine months post-randomization. A secondary aim is, through a case-control study, to investigate whether participants in the trial differ from patients receiving treatment as usual in municipalities where ILC and MOVE-I have not been implemented in OAT. This will be done by comparing number of offences leading to conviction 12 months post-randomization recorded in the national criminal justice register and number of emergency room contacts 12 months post-randomization recorded in the national hospital register. DISCUSSION: This is the first randomized, controlled clinical trial in OAT to test the effectiveness of ILC against a standardized comparison with structural elements to increase the likelihood of exposure to the elements of treatment. Results obtained from this study may have important clinical, social, and economic implications for publicly funded treatment of opioid use disorder. TRIAL REGISTRATION: ISRCTN, ISRCTN19554367 , registered on 04/09/2020.
Assuntos
Terapia Cognitivo-Comportamental , Transtornos Relacionados ao Uso de Opioides , Estudos de Casos e Controles , Aconselhamento , Humanos , Estilo de Vida , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do TratamentoRESUMO
BACKGROUND: Alcohol and other drug use disorders contribute substantially to the global burden of illness. The majority of people with substance use disorders do not receive any treatment for their problems, and developing treatments that are attractive and effective to patients should be a priority. However, whether treatment is best delivered in a group format or an individual format has only been studied to a very limited degree. The COMDAT (Combined Drug and Alcohol Treatment) trial evaluates the feasibility, acceptability, and cost effectiveness of MOVE group (MOVE-G) treatment versus MOVE individual (MOVE-I) treatment in four community-based outpatient treatment centres in Denmark. METHODS: A two-arm non-inferiority trial comparing MOVE-I (Pedersen et al., Drug Alcohol Depend 218:108363, 2020) with MOVE-G a combined group treatment for both alcohol use disorder and drug use disorder. The primary objective is to examine whether MOVE-G is non-inferior to MOVE-I in relation to abstinence from drug and/or alcohol, number of sessions received, and completion of treatment as planned. All participants will receive treatment based on cognitive behavioral therapy and motivational interviewing, vouchers for attendance and text reminders, as well as medication as needed (MOVE). Participants (n = 300) will be recruited over a one-year period at four public treatment centers in four Danish municipalities. A short screening will determine eligibility and randomization status. Hereafter, participants will be randomized to the two treatment arms. A thorough baseline assessment will be conducted approximately 1 week after randomization. Follow-up assessments will be conducted at 9 months post-randomization. In addition, patients' use of drugs and alcohol, and patients' wellbeing will be measured in all sessions. The main outcome measures are drug and alcohol intake at 9 months follow-up, number of sessions attended, and dropout from treatment. DISCUSSION: The present study will examine the potential and efficacy of combined groups (patients with alcohol and drug disorders in the same group) versus individually based treatment both based on the treatment method MOVE (Pedersen et al., Drug Alcohol Depend 218:108363, 2020). TRIAL REGISTRATION: ISRCTN88025085 , registration date 30/06/2020.
Assuntos
Terapia Cognitivo-Comportamental , Entrevista Motivacional , Transtornos Relacionados ao Uso de Substâncias , Humanos , Avaliação de Resultados em Cuidados de Saúde , Ensaios Clínicos Controlados Aleatórios como Assunto , Transtornos Relacionados ao Uso de Substâncias/terapia , Resultado do TratamentoRESUMO
Drinking is closely intertwined with social life among many adolescents, particularly in Europe. Group-based interventions, such as group-based motivational interviewing (group MI), have shown the capacity to prevent and reduce hazardous drinking and related problems among adolescents, but few examinations have been conducted in a European high school setting. This study examines the preliminary outcomes of a pilot group MI intervention among Danish adolescents. High school students (ages 15-18 years) were randomly allocated to two 1-h group MI sessions delivered in a school setting (N = 65) or an assessment only control condition (N = 67). Data were collected in August and November 2020 using online self-administrated questionnaires regarding the acceptability of the intervention and past month alcohol use. The pilot group MI intervention showed high feasibility and acceptability in this setting and with this age group. Group MI adolescents significantly reduced peak drinks per drinking day compared to assessment only adolescents (-2.7 drinks, p < 0.05). Results are discussed in relation to the metrics being evaluated during COVID-19 lockdown, including increased social restrictions at follow-up compared to baseline. Group MI shows promise for reducing hazardous alcohol use among Danish adolescents. In addition, the findings indicate the importance of building on and extending this work in future larger, better-powered randomized controlled trials.