Blended smartphone intervention for patients in opioid maintenance treatment in Iran: protocol for a randomized controlled trial.

BACKGROUND: The pattern of substance use in Iran is characterized by a high prevalence of opioid use and opioid use disorder (OUD). Although opioid maintenance therapy (OMT) has been introduced in Iran, approximately 50% of people with opioid use disorder remain unreached. Moreover, psychosocial treatment of OUD and common mental health symptoms during OMT is limited. Digital interventions have been shown to improve psychological distress, depression, anxiety, and post-traumatic stress disorder symptoms. In addition, providing psychoeducation and risk reduction counseling to prevent communicable diseases like HIV and infectious hepatitis is common via the Internet. However, despite these promising advances, no smartphone intervention in OMT has been investigated for the treatment of OUD and common comorbid mental health symptoms. OBJECTIVE: We examine the effectiveness of adding a blended smartphone intervention based on community reinforcement approach, motivational interviewing- and cognitive behavioral therapy compared to OMT as usual that aims to improve OMT outcomes and addresses common mental health symptoms in OMT patients in Iran. METHOD: Adults with opioid dependence entering 8 treatment centers in Tehran, Iran will be randomly assigned to receive either OMT plus a smartphone intervention or OMT as usual. The primary outcomes will be the percentage of negative urine tests for illicit, non-prescribed use of opioids (opium, heroin, tramadol) and treatment retention. Secondary outcomes will include the longest period of abstinence from the illicit, non-prescribed use of opioids (opium, heroin, and tramadol) confirmed by urine samples, changes in communicable disease risk-taking behaviors, changes in stress and common mental health symptoms, and client satisfaction. Data analysis will follow the intention-to-treat principle and employ (generalized) linear mixed models. DISCUSSION: This study will provide substantial knowledge for designing effective blended interventions for OUD. Moreover, it will investigate if treatment retention and OMT-related outcomes and common mental health symptoms can be improved by adding a smartphone intervention to OMT. TRIAL REGISTRATION: https://en.irct.ir/trial/53578 .

Comparing a mindfulness- and CBT-based guided self-help Internet- and mobile-based intervention against a waiting list control condition as treatment for adults with frequent cannabis use: a randomized controlled trial of CANreduce 3.0.

BACKGROUND: Though Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use. METHODS: This paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment. The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models. DISCUSSION: This RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number Registry: ISRCTN14971662 ; date of registration: 09/09/2021.

Hands-off: Study protocol of a two-armed randomized controlled trial of a web-based self-help tool to reduce problematic pornography use.

BACKGROUND AND AIMS: The past-year prevalence of problematic pornography use (PPU) was 1-6% in adult populations. As a result of treatment obstacles and barriers, such as unaffordable treatments, only a minority of problematic pornography users may seek treatment. Having a free, online, self-help program may overcome treatment barriers and may help those individuals who cannot receive traditional or offline treatment for PPU. Although the effectiveness of such online programs reducing substance use and problematic gambling have been reported, no prior study has examined the efficacy of an online self-help intervention aiming to reduce PPU. METHODS: This two-armed randomized controlled trial (RCT) will examine the effectiveness of an online self-help program (Hands-off) to reduce PPU, while also considering psychopathological comorbidities. The six-week intervention condition includes six core modules developed to reduce PPU based on motivational interviewing, cognitive behavioral therapy, mindfulness, and wise social-psychological intervention techniques. The target sample size is 242 participants. Self-report questionnaires will be administered at baseline, right after the end of the intervention, at one-month, and three-month follow-ups after the end of the intervention. The primary outcome will be the level of PPU. Secondary outcomes will include pornography use frequency, pornography craving, pornography use-avoidance self-efficacy, sex mindset, sexual satisfaction, negative and positive emotions, and life satisfaction. Data will be analyzed on an intention-to-treat basis using linear mixed models. RESULTS: Results will be reported at conferences and published in a scientific peer-reviewed journal. The participants will be sent a lay-person-friendly summary of the results via e-mail.

Short- and long-term effects of digital prevention and treatment interventions for cannabis use reduction: A systematic review and meta-analysis.

BACKGROUND: Frequent Cannabis use has been linked to a variety of negative mental, physical, and social consequences. We assessed the effects of digital prevention and treatment interventions on Cannabis use reduction in comparison with control conditions. METHODS: Systematic review with two separate meta-analyses. Thirty randomized controlled trials met the inclusion criteria for the review, and 21 were included in the meta-analyses. Primary outcome was self-reported Cannabis use at post-treatment and follow-up. Hedges's g was calculated for all comparisons with non-active control. Risk of bias was examined with the Cochrane risk-of-bias tool. RESULTS: The systematic review included 10 prevention interventions targeting 8138 participants (aged 12 to 20) and 20 treatment interventions targeting 5195 Cannabis users (aged 16 to 40). The meta-analyses showed significantly reduced Cannabis use at post-treatment in the prevention interventions (6 studies, N = 2564, g = 0.33; 95% CI 0.13 to 0.54, p = 0.001) and in the treatment interventions (17 comparisons, N = 3813, g = 0.12; 95% CI 0.02 to 0.22, p = 0.02) as compared with controls. The effects of prevention interventions were maintained at follow-ups of up to 12 months (5 comparisons, N = 2445, g = 0.22; 95% CI 0.12 to 0.33, p < 0.001) but were no longer statistically significant for treatment interventions. CONCLUSIONS: Digital prevention and treatment interventions showed small, significant reduction effects on Cannabis use in diverse target populations at post-treatment compared to controls. For prevention interventions, the post-treatment effects were maintained at follow-up up to 12 months later.

Multidimensional Family Therapy Reduces Self-Reported Criminality Among Adolescents With a Cannabis Use Disorder.

Multidimensional family therapy (MDFT) is an established treatment program for youth displaying multiproblem behavior. We examined whether MDFT decreased criminal offending among cannabis abusing adolescents, as compared with individual psychotherapy (IP). In a Western European randomized controlled trial comparing MDFT with IP, a sample of 169 adolescents with a cannabis disorder completed self-reports on criminal offending. Half indicated they had committed one or more criminal offenses in the 90 days before the baseline assessment. Follow-up assessments were at 6 and 12 months after randomization. The proportion of adolescents reporting nondelinquency increased during the study period, most so in the MDFT condition. In addition, MDFT lowered the number of violent offenses more than IP. This difference was not seen for property crimes. In cannabis abusing adolescents, MDFT is an effective treatment to prevent and reduce criminal offending. MDFT outperforms IP for violent crimes.

The Use of Prescription Drugs, Recreational Drugs, and "Soft Enhancers" for Cognitive Enhancement among Swiss Secondary School Students.

The use of prescription or recreational drugs for cognitive enhancement (CE) is prevalent among students. However, the prevalence of CE among Swiss school students is unknown. We therefore performed a cross-sectional online survey including ≥ 16-year-old students from bridge-year schools (10th grade), vocational schools, and upper secondary schools (10th-12th grade) in the Canton of Zurich to investigate the prevalence of and motives for the use of prescription drugs, recreational drugs, and/or freely available soft enhancers for CE. A total of 1,139 students were included. Of these, 54.5% reported the use of prescription drugs (9.2%), recreational drugs including alcohol (6.2%), or soft enhancers (51.3%) explicitly for CE at least once in their lives. The last-year and last-month prevalence for CE considering all substances was 45.5% and 39.5%, respectively. Soft enhancers were the substances that were most commonly used (ever, last-year, and last-month, respectively), including energy drinks (33.3%, 28.4%, and 24.6%), coffee (29.8%, 25.1%, and 21.9%), and tobacco (12.6%, 9.3%, and 8.3%). CE with methylphenidate was less prevalent (4.0%, 2.8%, and 2.0%). However, the use of prescription drugs, alcohol, or illegal drugs for CE was reported by 13.3% of the participants. The most common motives for use were to stay awake and improve concentration. CE was more prevalent among students who reported higher levels of stress or performance pressure and students with psychiatric disorders. In conclusion, half of the school students had used a substance at least once in their lives to improve school performance. Soft enhancers were most commonly used. Prevalence rates were similar to those reported by Swiss university students, indicating that the use of prescription or recreational drugs for CE already occurs before starting higher education. Performance pressure, stress, and psychiatric disorders may be associated with CE.

Multidimensional family therapy decreases the rate of externalising behavioural disorder symptoms in cannabis abusing adolescents: outcomes of the INCANT trial.

BACKGROUND: US-based trials have shown that Multidimensional Family Therapy (MDFT) not only reduces substance abuse among adolescents, but also decreases mental and behavioural disorder symptoms, most notably externalising symptoms. In the INCANT trial, MDFT decreased the rate of cannabis dependence among Western European youth. We now focus on other INCANT outcomes, i.e., lessening of co-morbidity symptoms and improvement of family functioning. METHODS: INCANT was a randomised controlled trial comparing MDFT with individual therapy (IP) at and across sites in Berlin, Brussels, Geneva, The Hague, and Paris. We recruited 450 boys and girls aged 13 up to 18 years with a cannabis use disorder, and their parent(s), and followed them for 12 months. Mental and behavioural characteristics (classified as 'externalising' or 'internalising') and family conflict and cohesion were assessed. RESULTS: From intake through 12 months, MDFT and IP groups improved on all outcome measures. Models including treatment, site, and referral source showed that MDFT outperformed IP in reducing externalising symptoms.Adolescents were either self-referred to treatment (mostly on the initiative from people close to the teen) or referred under some measure of coercion by an external authority. These two groups reacted equally well to treatment. CONCLUSIONS: Both MDFT and IP reduced the rate of externalising and internalising symptoms and improved family functioning among adolescents with a cannabis use disorder. MDFT outperformed IP in decreasing the rate of externalising symptoms. Contrary to common beliefs among therapists in parts of Western Europe, the 'coerced' adolescents did at least as well in treatment as the self-referred adolescents.MDFT shows promise as a treatment for both substance use disorders and externalising symptoms. TRIAL REGISTRATION ISRNCT: ISRCTN51014277.

Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial.

BACKGROUND: Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. METHODS: This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. RESULTS: At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). CONCLUSIONS: A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. TRIAL REGISTRATION: Current Controlled Trials ISRCTN72839675.