Preferences of Young Adults With Psychosis for Cannabis-Focused Harm Reduction Interventions: A Cross-Sectional Study: Préférences des jeunes adultes souffrant de psychose pour les interventions de réduction des méfaits axées sur le cannabis : une étude transversale.

OBJECTIVES: Cannabis use is common in people with early-phase psychosis (EP) and is associated with worse treatment outcomes. Few targeted interventions for cannabis use behaviour in this population exist, most focusing on abstinence, none focusing on harm reduction. Many people with EP will not seek treatment for their cannabis use with current therapeutic options. Understanding preferences for cannabis-focused harm reduction interventions may be key to improving outcomes. This study aimed to determine preferences of young adults with EP who use cannabis for cannabis-focused harm reduction interventions. METHODS: Eighty-nine young adults across Canada with EP interested in reducing cannabis-related harms were recruited. An online questionnaire combining conventional survey methodology and two unique discrete choice experiments (DCEs) was administered. One DCE focused on attributes of core harm reduction interventions (DCE 1) and the second on attributes of boosters (DCE 2). We analysed these using mixed ranked-ordered logistic regression models. Preference questions using conventional survey methodology were analysed using summary statistics. RESULTS: Preferred characteristics for cannabis-focused harm reduction interventions (DCE 1) were: shorter sessions (60 min vs. 10 min, odds ratio (OR): 0.72; P < 0.001); less frequent sessions (daily vs. monthly, OR: 0.68; P < 0.001); shorter interventions (3 months vs. 1 month, OR: 0.80; P < 0.01); technology-based interventions (vs. in-person, OR: 1.17; P < 0.05). Preferences for post-intervention boosters (DCE 2) included opting into boosters (vs. opting out, OR: 3.53; P < 0.001) and having shorter boosters (3 months vs. 1 month, OR: 0.79; P < 0.01). Nearly half of the participants preferred to reduce cannabis use as a principal intervention goal (vs. using in less harmful ways or avoiding risky situations). CONCLUSIONS: Further research is required to see if technology-based harm reduction interventions for cannabis featuring these preferences translate into greater engagement and improved outcomes in EP patients.

Prescription psychostimulants for the treatment of amphetamine-type stimulant use disorder: A systematic review and meta-analysis of randomized placebo-controlled trials.

BACKGROUND AND AIMS: There is currently no standard of care for pharmacological treatment of amphetamine-type stimulant (ATS) use disorder (ATSUD). This systematic review with meta-analysis (PROSPERO CRD42022354492) aimed to pool results from randomized placebo-controlled trials (RCTs) to evaluate efficacy and safety of prescription psychostimulants (PPs) for ATSUD. METHODS: Major indexing sources and trial registries were searched to include records published before 29 August 2022. Eligible studies were RCTs evaluating efficacy and safety of PPs for ATSUD. Risk of bias (RoB) was assessed using the Cochrane RoB 2 tool. Risk ratio (RR) and risk difference were calculated for random-effect meta-analysis of dichotomous variables. Mean difference and standardized mean difference (SMD) were calculated for random-effect meta-analysis of continuous variables. RESULTS: Ten RCTs (n = 561 participants) were included in the meta-analysis. Trials studied methylphenidate (n = 7), with daily doses of 54-180 mg, and dextroamphetamine (n = 3), with daily doses of 60-110 mg, for 2-24 weeks. PPs significantly decreased end-point craving [SMD  -0.29; 95% confidence interval (CI) = -0.55, -0.03], while such a decrease did not reach statistical significance for ATS use, as evaluated by urine analysis (UA) (RR = 0.93; 95% CI = 0.85-1.01). No effect was observed for self-reported ATS use, retention in treatment, dropout following adverse events, early-stage craving, withdrawal and depressive symptoms. In a sensitivity analysis, treatment was associated with a significant reduction in UA positive for ATS (RR = 0.89; 95% CI = 0.79-0.99) after removing studies with a high risk of bias. In subgroup analyses, methylphenidate and high doses of PPs were negatively associated with ATS use by UA, while higher doses of PPs and treatment duration (≥ 20 weeks) were positively associated with longer retention. CONCLUSIONS: Among individuals with amphetamine-type stimulant use disorder, treatment with prescription psychostimulants may decrease ATS use and craving. While effect size is limited, it may increase with a higher dosage of medications.

Evaluation of a Cannabis Harm Reduction Intervention for People With First-Episode Psychosis: Protocol for a Pilot Multicentric Randomized Trial.

BACKGROUND: Cannabis use is highly prevalent in young people with first-episode psychosis (FEP). Most report cannabis use and are often diagnosed with a cannabis use disorder upon admission to specialized services for psychosis. Cannabis use in this population is associated with worse clinical and psychosocial outcomes, rendering it an important clinical target. Despite this, few cannabis-specific interventions have been developed for FEP and empirically evaluated through randomized controlled trials. Most evaluated interventions have targeted cannabis abstinence, with limited efficacy, but none have centered on harm reduction outcomes for people with FEP who use cannabis. Early intervention services (EIS), the standard of care for FEP, have not successfully addressed problematic cannabis use in people with FEP either. Clinical trials are needed to explore the potential of harm reduction strategies, although these should be preceded by robust pilot studies to establish optimal design and approaches. OBJECTIVE: Recognizing the need for harm reduction strategies for individuals with FEP who use cannabis and based on research on patients' preferences supporting harm reduction interventions, we developed a mobile app-based cannabis harm reduction intervention for this population. This intervention is called Cannabis Harm-reducing Application to Manage Practices Safely (CHAMPS). Here, we describe the protocol for a multicenter, 2-arm, parallel group, randomized pilot trial evaluating the acceptability of CHAMPS for people with FEP who use cannabis and the feasibility of conducting a full-scale trial in this population using CHAMPS. The impact on key clinical outcomes will also be explored. METHODS: This pilot trial aims to recruit 100 young people with FEP using cannabis from 6 Canadian EIS clinics. Participants will be randomized in a 1:1 ratio to CHAMPS+EIS or EIS-only. CHAMPS acceptability will be assessed using completion rates for the intervention arm. Trial feasibility will be assessed using a retention rate for randomized participants. Secondary outcomes will explore tendencies of change in the use of protective behavioral strategies and in motivation to change strategies. Exploratory outcomes include cannabis use-related problems, other substance use, the severity of dependence, psychotic symptoms, and health care service use. RESULTS: Recruitment began in December 2021. Data collection and analysis are expected to be completed in early 2024. Study results describing CHAMPS acceptability and trial feasibility will then be submitted for publication in a peer-reviewed journal. CONCLUSIONS: CHAMPS uniquely combines evidence-based approaches, patient perspectives, and mobile health technology to support harm reduction in people with FEP who use cannabis. Attaining adequate acceptability and feasibility through this trial may justify further exploration of harm reduction tools, particularly within the context of conducting a larger-scale randomized controlled trial. This pilot trial has the potential to advance knowledge for researchers and clinicians regarding a feasible and user-acceptable research design in the cannabis and early psychosis fields. TRIAL REGISTRATION: ClinicalTrials.gov NCT04968275, https://clinicaltrials.gov/ct2/show/NCT04968275. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/53094.

Reducing Cannabis Use in Young Adults With Psychosis Using iCanChange, a Mobile Health App: Protocol for a Pilot Randomized Controlled Trial (ReCAP-iCC).

BACKGROUND: Cannabis use is the most prevalent among adolescents and young adults; frequent consumption is associated with cannabis use disorder (CUD) and psychosis, with a high prevalence (up to 50%) of CUD in individuals with first-episode psychosis (FEP). Early Intervention Services (EIS) for psychosis include face-to-face psychosocial interventions for CUD, because reducing or discontinuing cannabis use improves clinical and health care service use outcomes. However, multiple barriers (eg, staff availability and limited access to treatment) can hinder the implementation of these interventions. Mobile health (mHealth) interventions may help circumvent some of these barriers; however, to date, no study has evaluated the effects of mHealth psychological interventions for CUD in individuals with FEP. OBJECTIVE: This study describes the protocol for a pilot randomized controlled trial using a novel mHealth psychological intervention (iCanChange [iCC]) to address CUD in young adults with FEP. iCC was developed based on clinical evidence showing that in individuals without psychosis, integrating the principles of cognitive behavioral therapy, motivational interviewing, and behavioral self-management approaches are effective in improving cannabis use-related outcomes. METHODS: Consenting individuals (n=100) meeting the inclusion criteria (eg, aged 18-35 years with FEP and CUD) will be randomly allocated in a 1:1 ratio to the intervention (iCC+modified EIS) or control (EIS) group. The iCC is fully automatized and contains 21 modules that are completed over a 12-week period and 3 booster modules available during the 3-month follow-up period. Validated self-report measures will be taken via in-person assessments at baseline and at 6, 12 (end point), and 24 weeks (end of trial); iCC use data will be collected directly from the mobile app. Primary outcomes are intervention completion and trial retention rates, and secondary outcomes are cannabis use quantity, participant satisfaction, app use, and trial recruiting parameters. Exploratory outcomes include severity of psychotic symptoms and CUD severity. For primary outcomes, we will use the chi-square test using data collected at week 12. We will consider participation in iCC acceptable if ≥50% of the participants complete at least 11 out of 21 intervention modules and the trial feasible if attrition does not reach 50%. We will use analysis of covariance and mixed-effects models for secondary outcomes and generalized estimating equation multivariable analyses for exploratory outcomes. RESULTS: Recruitment began in July 2022, and data collection is anticipated to be completed in July 2024. The main results are expected to be submitted for publication in 2024. We will engage patient partners and other stakeholders in creating a multifaceted knowledge translation plan to reach a diverse audience. CONCLUSIONS: If feasible, this study will provide essential data for a larger-scale efficacy trial of iCC on cannabis use outcomes in individuals with FEP and CUD. TRIAL REGISTRATION: ClinicalTrials.gov NCT05310981; https://www.clinicaltrials.gov/ct2/show/NCT05310981. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/40817.

Identifying risk-thresholds for the association between frequency of cannabis use and development of cannabis use disorder: A systematic review and meta-analysis.

BACKGROUND: Cannabis use disorder (CUD) affects one-in-five cannabis users, presenting a major contributor to cannabis-associated disease burden. Epidemiological data identify the frequency of cannabis use as a risk factor for CUD. This review aimed to determine quantifiable risk-thresholds of the frequency of cannabis use for developing CUD. METHODS: Systematic search of Medline, EMBASE, PsycInfo, CINAHL, and Web of Science for cohort/case-control studies that assessed the association between frequency of cannabis use and CUD from 2000 to 2022. Effect estimates were converted to risk ratios (RR). A random-effects multi-level multivariate meta-analytic approach was utilized, and sensitivity analyses conducted. Quality of included studies was assessed with the Newcastle Ottawa Scale. RESULTS: Six prospective cohort studies were included in this review, drawn from two main source studies. Random-effect modeling showed a significant log-linear dose-response association between the frequency of cannabis use and CUD risk (p < 0.0001). The risk of CUD increased from RR:2.03 (95% CI:1.85-2.22) for 'yearly' use, to RR:4.12 (95% CI:3.44-4.95) for 'monthly" use, RR:8.37 (95% CI:6.37-11.00) for 'weekly' use, and RR:16.99 (95% CI:11.80-24.46) for 'daily' use. Multi-level modeling showed an absolute risk increase (ARI) from 3.5% (95% CI:2.6-4.7) for 'yearly' use, to 8.0% (95% CI:5.3-12.1) for 'monthly' use, to 16.8% (95% CI:8.8-32.0) for 'weekly' use, and 36% (95% CI:27.047.9) for 'daily' use. CONCLUSION: A limited risk of CUD as a potential outcome of cannabis use exists even at infrequent levels of use, but significantly increases as frequency of use increases. Corresponding information should be conveyed to cannabis users as part of targeted prevention messaging to promote safer cannabis use.

Psychometric properties of the French and English short form of the Protective Behavioural Strategies for Marijuana Scale in Canadian university students.

BACKGROUND: The Protective Behavioural Strategies for Marijuana (PBSM-17) scale serves to identify and measure strategies employed by young adults before, during or after cannabis use. After the adaptation and translation of the PBSM-17 into French, a methodological study was conducted to evaluate the psychometric properties of this French version (FV) and of the original English version (EV) in a sample of bilingual Canadian university students. METHODS: A total of 211 cannabis users (mean age=22.1 years) completed a sociodemographic questionnaire, a question on frequency of cannabis use (four categories: 1-3 times a month, once a week, more than once a week, everyday) and both versions (FV and EV) of the PBSM-17. RESULTS: Both versions had similar internal reliability (α=0.91; α=0.88). The one-factor solution explained 36.46% of the variance for the FV and 42.26% for the EV. As hypothesised, greater use of protective behavioural strategies was related to lower frequency of cannabis use. One-way ANOVA test results revealed a statistically significant difference in use of strategies by frequency of cannabis use for both the FV (F(3, 207)=27.38, p<0.001) and EV (F(3, 207)=29.32, p<0.001). Post hoc comparisons showed that everyday users employed fewer strategies on average than lower-frequency users. CONCLUSION: The FV and EV of the PBSM-17 demonstrated satisfactory psychometric properties. The proposed FV of the PBSM-17 is a reliable instrument that could be used for research and clinical purposes. Protective behavioural strategies can serve as indicator of lower-risk cannabis use and could be targeted in prevention interventions.

[French translation, cultural adaptation and assessment of preliminary psychometric properties of the Protective Behavioral Strategies for Marijuana Scale]. / Traduction française, adaptation culturelle et évaluation des propriétés psychométriques préliminaires de l'échelle des stratégies de protection comportementale liées à la consommation de cannabis.

OBJECTIVE: Young adults (18- to 24-year-olds) constitute the age group with the highest proportion of cannabis users. In the context of legalization, it is important to promote lower-risk cannabis use. The Protective Behavioral Strategies for Marijuana Scale (PBSM-17) identifies strategies used by consumers. However, this scale is not available in French and is not adapted to the Canadian context. This article presents the process that led to the translation, cultural adaptation and evaluation of the preliminary psychometric properties of PBSM-17. METHOD: The methodological study was carried out in six steps. The first four steps led to the translation towards French and adaptation of the scale. A validation among 12 young people contributed to establish the criterion equivalency (step 5). The evaluation of psychometric properties (step 6) was carried out among 211 bilingual university students (61 % women; mean age 22 years old). RESULTS: The French version presents satisfactory preliminary psychometric properties: internal consistency is acceptable (α = 0.88); criterion equivalency was established between the French and the original English version (t (210) = 1.04, p = 0.30; 95% CI [-0.20, 0.63]). The scores obtained on both versions by the same participant were found to be strongly correlated (r = 0.95, p <0.001). CONCLUSION: The results support the use of the French version of PBSM-17. The proposed protective strategies can be used as a measurement tool and represent behaviors that can be targeted in a lower-risk cannabis use context.

OBJECTIF: Les jeunes de 18 à 24 ans constituent la plus grande proportion de consommateurs de cannabis. Dans un contexte de légalisation de cette substance, il importe de promouvoir une consommation à moindre risque. L'échelle Protective Behavioral Strategies for Marijuana Scale (PBSM-17) permet d'identifier les stratégies de protection comportementale utilisées chez les consommateurs. Toutefois, cette échelle n'est pas disponible en français et n'est pas adaptée au contexte canadien. Cet article présente la démarche ayant mené à la traduction, l'adaptation culturelle et l'évaluation des propriétés psychométriques préliminaires du PBSM-17. MÉTHODE: L'étude méthodologique s'est déroulée en six étapes. Les quatre premières étapes ont mené à la traduction et l'adaptation de l'échelle. La validation auprès de 12 jeunes a permis d'établir l'équivalence conceptuelle. L'évaluation des propriétés psychométriques a été réalisée auprès de 211 étudiants universitaires bilingues (61 % femme; âge moyen 22 ans). RÉSULTATS: La version traduite et adaptée présente des propriétés psychométriques préliminaires satisfaisantes : la cohérence interne est acceptable (α = 0,88); l'équivalence de critères (validité de construit) est établie entre la version française et la version anglaise (t (210) = 1,04, p = 0,30 ; IC 95 % [-0,20, 0,63]). Les scores obtenus aux deux versions par le même participant s'avèrent fortement corrélées (r = 0,95, p < 0,001). CONCLUSION: Les résultats soutiennent l'utilisation de la version française du PBSM-17. Les stratégies de protection proposées peuvent être utilisées comme outil de mesure et représentent des comportements à adopter dans un contexte d'usage du cannabis à moindre risque.

Technology-Based Psychological Interventions for Young Adults With Early Psychosis and Cannabis Use Disorder: Qualitative Study of Patient and Clinician Perspectives.

BACKGROUND: The persistence of cannabis use disorder (CUD) in young adults with first-episode psychosis (FEP) is associated with poor clinical and functional outcomes. Face-to-face psychological interventions are effective in treating CUD. However, their use in early intervention services (EISs) for psychosis is inconsistent because of barriers, including high workload and heterogeneity in training of clinicians and lack of motivation for treatment among patients. Tailoring new technology-based psychological interventions (TBPIs) to overcome these barriers is necessary to ensure their optimal acceptability. OBJECTIVE: The aim of this study is twofold: to explore psychological intervention practices and intervention targets that are relevant for treating CUD in individuals with early psychosis and to explore factors related to the development and implementation of a technology-assisted psychological intervention. METHODS: A total of 10 patients undergoing treatment for FEP and CUD in EISs participated in a focus group in June 2019. Semistructured individual interviews were conducted with 10 clinicians working in first-episode clinics in the province of Québec, Canada. A hybrid inductive-deductive approach was used to analyze data. For the deductive analysis, we used categories of promoting strategies found in the literature shown to increase adherence to web-based interventions for substance use (ie, tailoring, reminders, delivery strategies, social support, and incentives). For the inductive analysis, we identified new themes through an iterative process of reviewing the data multiple times by two independent reviewers. RESULTS: Data were synthesized into five categories of factors that emerged from data collection, and a narrative synthesis of commonalities and differences between patient and clinician perspectives was produced. The categories included attitudes and beliefs related to psychological interventions (eg, behavioral stage of change), strategies for psychological interventions (eg, motivational interviewing, cognitive behavioral therapy, psychoeducation, stress management), incentives (eg, contingency management), general interest in TBPIs (eg, facilitators and barriers of TBPIs), and tailoring of TBPIs (eg, application needs and preferences, outcome measures of interest for clinicians). CONCLUSIONS: This study provides a comprehensive portrait of the multifaceted needs and preferences of patients and clinicians related to TBPIs. Our results can inform the development of smartphone- or web-based psychological interventions for CUD in young adults with early psychosis.

Preventive interventions targeting cannabis use and related harms in people with psychosis: A systematic review.

AIM: While most users will not experience severe adverse health outcomes from cannabis, it can be associated with negative outcomes in people with psychosis. People with psychosis who use cannabis have more severe psychiatric symptoms, higher rates of hospitalization, and diminished psychosocial functioning compared to those who do not use cannabis. Most studies of people with psychotic disorders have focused on cannabis use treatments and only a few on preventive interventions for cannabis. This systematic review aims to evaluate the effectiveness of preventive interventions focusing on cannabis use for people with psychosis. METHODS: We searched CINAHL Plus, EBM reviews, EMBASE, MEDLINE, PsycInfo and PubMed databases for controlled studies assessing the effects of preventive interventions on cannabis use and related harms in people with psychosis. We conducted the search using a combination of the following concepts: cannabis, psychosis, intervention and prevention. Risk of bias was assessed. RESULTS: The search yielded 11 460 unique studies. Of these, five studies met our eligibility criteria. None of the studies demonstrated clear efficacy of prevention interventions in reducing cannabis use, and none measured cannabis-related harms. All studies had high risk of bias. CONCLUSION: The small number of studies and the considerable risk of bias made it difficult to conclude whether any of the existing interventions were promising. With increased acceptance and accessibility of cannabis due to liberalizing cannabis policies, it is imperative to improve the evidence base for preventive interventions, in particular their effectiveness in decreasing the risk of cannabis-related harms in people with psychosis.

Cannabidiol for the treatment of psychosis among patients with schizophrenia and other primary psychotic disorders: A systematic review with a risk of bias assessment.

Current treatments for primary psychotic disorders include antipsychotics, some of which have significant side effects or suboptimal efficacy. Cannabidiol is a cannabinoid with potential antipsychotic properties. This systematic review examines the use of cannabidiol as an antipsychotic treatment for primary psychotic disorders. CINAHL, EBM, EMBASE, MEDLINE and PubMed databases were searched from 1970 to 2019 for experimental and observational studies evaluating the antipsychotic and cognitive modulation properties of cannabidiol in individuals with psychotic disorders. There were eight eligible studies evaluating the antipsychotic potential of cannabidiol, involving a total of 210 participants. Due to study heterogeneity, we present the extracted data on general psychopathology, positive and negative symptoms, cognition and functioning outcomes as a narrative synthesis. We found limited evidence supporting antipsychotic efficacy for cannabidiol and none supporting its benefits for cognition or functioning. Cannabidiol treatment had an advantageous side effect profile compared to other antipsychotics and was well tolerated across studies. Observational studies had a higher risk of bias than experimental studies. Factors potentially contributing to variability in outcome results included cannabidiol dosage, treatment duration, use as an adjunctive treatment and participant inclusion criteria, which warrant further investigation to determine whether cannabidiol can be effective as a treatment for psychosis.

Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

BACKGROUND: A large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of "positive" results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified. METHODS: CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses. RESULTS: 108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases. CONCLUSIONS: The proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

Depression screening and patient outcomes in pregnancy or postpartum: a systematic review.

OBJECTIVE: Clinical practice guidelines disagree on whether health care professionals should screen women for depression during pregnancy or postpartum. The objective of this systematic review was to determine whether depression screening improves depression outcomes among women during pregnancy or the postpartum period. METHODS: Searches included the CINAHL, EMBASE, ISI, MEDLINE, and PsycINFO databases through April 1, 2013; manual journal searches; reference list reviews; citation tracking of included articles; and trial registry reviews. RCTs in any language that compared depression outcomes between women during pregnancy or postpartum randomized to undergo depression screening versus women not screened were eligible. RESULTS: There were 9,242 unique titles/abstracts and 15 full-text articles reviewed. Only 1 RCT of screening postpartum was included, but none during pregnancy. The eligible postpartum study evaluated screening in mothers in Hong Kong with 2-month-old babies (N=462) and reported a standardized mean difference for symptoms of depression at 6 months postpartum of 0.34 (95% confidence interval=0.15 to 0.52, P<0.001). Standardized mean difference per 44 additional women treated in the intervention trial arm compared to the non-screening arm was approximately 1.8. Risk of bias was high, however, because the status of outcome measures was changed post-hoc and because the reported effect size per woman treated was 6-7 times the effect sizes reported in comparable depression care interventions. CONCLUSION: There is currently no evidence from any well-designed and conducted RCT that screening for depression would benefit women in pregnancy or postpartum. Existing guidelines that recommend depression screening during pregnancy or postpartum should be re-considered.

The Scleroderma Patient-centered Intervention Network (SPIN) Cohort: protocol for a cohort multiple randomised controlled trial (cmRCT) design to support trials of psychosocial and rehabilitation interventions in a rare disease context.

INTRODUCTION: Psychosocial and rehabilitation interventions are increasingly used to attenuate disability and improve health-related quality of life (HRQL) in chronic diseases, but are typically not available for patients with rare diseases. Conducting rigorous, adequately powered trials of these interventions for patients with rare diseases is difficult. The Scleroderma Patient-centered Intervention Network (SPIN) is an international collaboration of patient organisations, clinicians and researchers. The aim of SPIN is to develop a research infrastructure to test accessible, low-cost self-guided online interventions to reduce disability and improve HRQL for people living with the rare disease systemic sclerosis (SSc or scleroderma). Once tested, effective interventions will be made accessible through patient organisations partnering with SPIN. METHODS AND ANALYSIS: SPIN will employ the cohort multiple randomised controlled trial (cmRCT) design, in which patients consent to participate in a cohort for ongoing data collection. The aim is to recruit 1500-2000 patients from centres across the world within a period of 5 years (2013-2018). Eligible participants are persons ≥18 years of age with a diagnosis of SSc. In addition to baseline medical data, participants will complete patient-reported outcome measures every 3 months. Upon enrolment in the cohort, patients will consent to be contacted in the future to participate in intervention research and to allow their data to be used for comparison purposes for interventions tested with other cohort participants. Once interventions are developed, patients from the cohort will be randomly selected and offered interventions as part of pragmatic RCTs. Outcomes from patients offered interventions will be compared with outcomes from trial-eligible patients who are not offered the interventions. ETHICS AND DISSEMINATION: The use of the cmRCT design, the development of self-guided online interventions and partnerships with patient organisations will allow SPIN to develop, rigourously test and effectively disseminate psychosocial and rehabilitation interventions for people with SSc.