A pilot economic evaluation of computerized cognitive behavioral therapy for alcohol use disorder as an addition and alternative to traditional therapy.

BACKGROUND: Computer-based delivery of cognitive behavioral therapy (CBT) may be a less costly approach to increase dissemination and implementation of evidence-based treatments for alcohol use disorder (AUD). However, comprehensive evaluations of costs, cost-effectiveness, and cost-benefit of computer-delivered interventions are rare. METHODS: This study used data from a completed randomized clinical trial to evaluate the cost-effectiveness and cost-benefit of a computer-based version of CBT (CBT4CBT) for AUD. Sixty-three participants were randomized to receive one of the following treatments at an outpatient treatment facility and attended at least one session: (1) treatment as usual (TAU), (2) CBT4CBT plus treatment as usual (CBT4CBT+TAU), or (3) CBT4CBT plus brief monitoring. RESULTS: Median protocol treatment costs per participant differed significantly between conditions, Kruskal-Wallis H(2) = 8.40, p = 0.02, such that CBT4CBT+TAU and CBT4CBT+monitoring each cost significantly more per participant than TAU. However, when nonprotocol treatment costs were included, total treatment costs per participant did not differ significantly between conditions. Median incremental cost-effective ratios (ICERs) revealed that CBT4CBT+TAU was more costly and more effective than TAU. It cost $35.08 to add CBT4CBT to TAU to produce a reduction of one additional drinking day per month between baseline and the end of the 8-week treatment protocol: CBT4CBT+monitoring cost $33.70 less to produce a reduction of one additional drinking day per month because CBT4CBT+monitoring was less costly than TAU and more effective at treatment termination, though not significantly so. Net benefit analyses suggested that costs of treatment, regardless of condition, did not offset monthly costs related to healthcare utilization, criminal justice involvement, and employment disruption between baseline and 6-month follow-up. Benefit-cost ratios were similar for each condition. CONCLUSIONS: Results of this pilot economic evaluation suggest that an 8-week course of CBT4CBT may be a cost-effective addition and potential alternative to standard outpatient treatment for AUD. Additional research is needed to generate conclusions about the cost-benefit of providing CBT4CBT to treatment-seeking individuals participating in standard outpatient treatment.

Self-managed, computerised word finding therapy as an add-on to usual care for chronic aphasia post-stroke: An economic evaluation.

OBJECTIVE: To examine the cost-effectiveness of self-managed computerised word finding therapy as an add-on to usual care for people with aphasia post-stroke. DESIGN: Cost-effectiveness modelling over a life-time period, taking a UK National Health Service (NHS) and personal social service perspective. SETTING: Based on the Big CACTUS randomised controlled trial, conducted in 21 UK NHS speech and language therapy departments. PARTICIPANTS: Big CACTUS included 278 people with long-standing aphasia post-stroke. INTERVENTIONS: Computerised word finding therapy plus usual care; usual care alone; usual care plus attention control. MAIN MEASURES: Incremental cost-effectiveness ratios (ICER) were calculated, comparing the cost per quality adjusted life year (QALY) gained for each intervention. Credible intervals (CrI) for costs and QALYs, and probabilities of cost-effectiveness, were obtained using probabilistic sensitivity analysis. Subgroup and scenario analyses investigated cost-effectiveness in different subsets of the population, and the sensitivity of results to key model inputs. RESULTS: Adding computerised word finding therapy to usual care had an ICER of £42,686 per QALY gained compared with usual care alone (incremental QALY gain: 0.02 per patient (95% CrI: -0.05 to 0.10); incremental costs: £732.73 per patient (95% CrI: £674.23 to £798.05)). ICERs for subgroups with mild or moderate word finding difficulties were £22,371 and £21,262 per QALY gained respectively. CONCLUSION: Computerised word finding therapy represents a low cost add-on to usual care, but QALY gains and estimates of cost-effectiveness are uncertain. Computerised therapy is more likely to be cost-effective for people with mild or moderate, as opposed to severe, word finding difficulties.

Interventions of computerized psychotherapies for depression in Primary Care in Spain.

Currently, depression is a global health problem recognized by the WHO. The prevalence of this pathology in Primary Care is estimated at 19.5% worldwide, and 20.2% in Spain. In addition, the current intervention policies and protocols involve significant costs, both personal and economic, for people suffering from this disorder, as well as for society in general. On the other hand, the relapse rates after pharmacological interventions that are currently applied and the lack of effective specialized attention in mental health services reflect the need to develop new therapeutic strategies that are more accessible and profitable. Therefore, one of the proposals that are being investigated in different parts of the world is the design and evaluation of therapeutic protocols applied through Information and Communication Technologies, especially through the Internet and computer programs. The objective of this work was to present the current situation in Spain regarding the use of these interventions for the treatment of depression in Primary Care. The main conclusion is that although there is scientific evidence on the effectiveness of these programs, there are still important barriers that hinder their application in the public system, and also the need to develop implementation studies that facilitate the transition from research to clinical practice.

Efficacy and cost-effectiveness of an unguided, internet-based self-help intervention for social anxiety disorder in university students: protocol of a randomized controlled trial.

BACKGROUND: Social anxiety disorder (SAD) is highly prevalent among university students, but the majority of affected students remain untreated. Internet- and mobile-based self-help interventions (IMIs) may be a promising strategy to address this unmet need. This study aims to investigate the efficacy and cost-effectiveness of an unguided internet-based treatment for SAD among university students. The intervention is optimized for the treatment of university students and includes one module targeting fear of positive evaluations that is a neglected aspect of SAD treatment. METHODS: The study is a two arm randomized controlled trial in which 200 university students with a primary diagnosis of SAD will be assigned randomly to either a wait-list control group (WLC) or the intervention group (IG). The intervention consists of 9 sessions of an internet-based cognitive-behavioral treatment, which also includes a module on fear of positive evaluation (FPE). Guidance is delivered only on the basis of standardized automatic messages, consisting of positive reinforcements for session completion, reminders, and motivational messages in response to non-adherence. All participants will additionally have full access to treatment as usual. Diagnostic status will be assessed through Structured Clinical Interviews for DSM Disorders (SCID). Assessments will be completed at baseline, 10 weeks and 6-month follow-up. The primary outcome will be SAD symptoms at post-treatment, assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). Secondary outcomes will include diagnostic status, depression, quality of life and fear of positive evaluation. Cost-effectiveness and cost-utility analyses will be evaluated from a societal and health provider perspective. DISCUSSION: Results of this study will contribute to growing evidence for the efficacy and cost-effectiveness of unguided IMIs for the treatment of SAD in university students. Consequently, this trial may provide valuable information for policy makers and clinicians regarding the allocation of limited treatment resources to such interventions. TRIAL REGISTRATION: DRKS00011424 (German Clinical Trials Register (DRKS)) Registered 14/12/2016.

Efficacy and cost-effectiveness of Internet-based selective eating disorder prevention: study protocol for a randomized controlled trial within the ProHEAD Consortium.

BACKGROUND: The development of efficacious, cost-effective, and widely accessible programs for the prevention of eating disorders (EDs) is crucial in order to reduce the ED-related burden of illness. Programs using dissonance-based and cognitive behavioral approaches are most effective for the selective prevention of ED. Internet-based delivery is assumed to maximize the reach and impact of preventive efforts. However, the current evidence for Internet-based ED prevention is limited. The present trial evaluates the efficacy and cost-effectiveness of two new interventions (based on dissonance theory and principles of cognitive behavioral therapy (CBT)) that are implemented as add-ons to the existing Internet-based ED prevention program ProYouth. METHODS: The trial is one of five sub-projects of the German multicenter consortium ProHEAD. It is a three-arm, parallel, randomized controlled superiority trial. Participants will be randomized to (1) the online program ProYouth (active control condition) or (2) ProYouth plus a structured dissonance-based module or (3) ProYouth plus a CBT-based chat group intervention. As part of ProHEAD, a representative school-based sample of N = 15,000 students (≥ 12 years) will be screened for mental health problems. N = 309 participants at risk for ED (assessed with the Weight Concerns Scale (WCS) and the Short Evaluation of Eating Disorders (SEED)) will be included in the present trial. Online assessments will be conducted at baseline, at end of intervention (6 weeks), at 6 months follow-up, and - as part of ProHEAD - at 12 and 24 months follow-up. The primary outcome is ED-related impairment (assessed with the Child version of the Eating Disorder Examination-Questionnaire (ChEDE-Q)) at the end of the intervention. Secondary outcomes include ED-related symptomatology at follow-up, ED-related stigma, ED-related help-seeking, and acceptance of and compliance with the interventions. For the health economic evaluation data on costs of the interventions, healthcare utilization and health-related quality of life will be assessed. DISCUSSION: This is the first study augmenting a flexible prevention approach such as ProYouth with structured evidence-based modules in order to overcome some of the key limitations in the current practice of ED prevention. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00014679 . Registered on 25 April 2018.

Efficacy and cost-effectiveness of two online interventions for children and adolescents at risk for depression (E.motion trial): study protocol for a randomized controlled trial within the ProHEAD consortium.

BACKGROUND: Depression is a serious mental health problem and is common in children and adolescents. Online interventions are promising in overcoming the widespread undertreatment of depression and in improving the help-seeking behavior in children and adolescents. METHODS: The multicentre, randomized controlled E.motion trial is part of the German ProHEAD consortium (Promoting Help-seeking using E-technology for ADolescents). The objective of the trial is to investigate the efficacy and cost-effectiveness of two online interventions to reduce depressive symptomatology in high-risk children and adolescents with subsyndromal symptoms of depression in comparison to an active control group. Participants will be randomized to one of three conditions: (1) Intervention 1, a clinician-guided self-management program (iFightDepression®); (2) Intervention 2, a clinician-guided group chat intervention; and (3) Control intervention, a psycho-educational website on depressive symptoms. Interventions last six weeks. In total, N = 363 children and adolescents aged ≥ 12 years with Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) scores in the range of 5-9 will be recruited at five study sites across Germany. Online questionnaires will be administered before onset of the intervention, at the end of the intervention, and at the six-month follow-up. Further, children and adolescents will participate in the baseline screening and the one- and two-year school-based follow-up assessments integrated in the ProHEAD consortium. The primary endpoint is depression symptomatology at the end of intervention as measured by the PHQ-A score. Secondary outcomes include depression symptomatology at all follow-ups, help-seeking attitudes, and actual face-to-face help-seeking, adherence to and satisfaction with the interventions, depression stigma, and utilization and cost of interventions. DISCUSSION: This study represents the first randomized controlled trial (RCT) investigating efficacy and cost-effectiveness of two online interventions in children and adolescents aged ≥ 12 years at risk for depression. It aims to provide a better understanding of the help-seeking behavior of children and adolescents, potential benefits of E-mental health interventions for this age group, and new insights into so far understudied aspects of E-mental health programs, such as potential negative effects of online interventions. This knowledge will be used to tailor and improve future help offers and programs for children and adolescents and ways of treatment allocation. TRIAL REGISTRATION: German Register for Clinical Trials (DRKS), DRKS00014668 . Registered on 4 May 2018. International trial registration took place through the "international clinical trials registry platform" with the secondary ID S-086/2018.

A 4-year randomized trial comparing three outreach interventions to promote screening mammograms.

As population health has become a focus of health care payers and providers, interest has grown in mail, phone, and other forms of outreach for improving population rates of cancer screening. Translational research is needed to compare the effectiveness and cost of low- and high-intensity behavioral outreach interventions for promoting cancer screening. The purpose of the article is to compare the effectiveness in promoting biannual mammograms of three interventions delivered over 4 years to a primary care population with a high baseline mammography adherence of 83.3%. We randomized women aged 40-84 to reminder letter only (LO arm), letter + reminder call (RC arm), and two letters + counseling call (CC arm) involving tailored education and motivational interviewing. Mammography adherence (≥1 mammogram in the previous 24 months) at four time points was determined from insurance claims records. Over 4 years, 30,162 women were randomized. At the end of 4 years, adherence was highest in the RC arm (83.0%) compared with CC (80.8%) and LO (80.8%) arms (p = .03). Only 23.5% of women in the CC arm were reached and accepted full counseling. The incremental cost per additional mammogram for RC arm women was $30.45 over the LO arm cost. A simple reminder call can increase screening mammogram adherence even when baseline adherence is high. Some more complex behavioral interventions delivered by mail and phone as in this study may be less effective, due to limited participation of patients, a focus on ambivalence, lack of follow-up, and other factors.

Dissemination of computer-assisted cognitive-behavior therapy for depression in primary care.

Computer-assisted cognitive-behavior therapy (CCBT) for depression in primary care will be evaluated in a trial with 240 patients randomly assigned to CCBT or treatment as usual (TAU). The study will disseminate a therapy method found to be effective in psychiatric settings into primary care - a setting in which there have been significant problems in the delivery of adequate, evidence-based treatment for depression. The study will include a high percentage of disadvantaged (low-income) patients - a population that has been largely ignored in previous research in CCBT. There have been no previous studies of CCBT for depression in primary care that have enrolled large numbers of disadvantaged patients. The form of CCBT used in this study is designed to increase access to effective therapy, provide a cost-effective method, and be a sustainable model for wide-spread use in primary care. In order to deliver therapy in a practical manner that can be replicated in other primary care practices, patients with significant symptoms of depression will receive treatment with an empirically supported computer program that builds cognitive-behavior therapy skills. Support for CCBT will be provided by telephone and/or e-mail contact with a care coordinator (CC) instead of face-to-face treatment with a cognitive-behavior therapist. Outcome will be assessed by measuring CCBT completion rate, comprehension of CBT concepts, and satisfaction with treatment, in addition to ratings of depressive symptoms, negative thoughts, and quality of life. The cost-effectiveness analysis and exploration of possible predictors of outcome should help clinicians, health care organizations, and others plan further dissemination of CCBT in primary care.

An Internet-based Acceptance and Commitment Therapy intervention for older adults with anxiety complaints: study protocol for a cluster randomized controlled trial.

BACKGROUND: Anxiety is among the most prevalent and disabling mental health problems in older adults. Few older adults with mild to moderately severe anxiety symptoms receive adequate interventions, putting them at risk for developing anxiety disorders, depression, and various somatic problems. Effective, low-threshold interventions should be developed. Blended care, in which a web-based intervention is combined with a limited amount of face-to-face contacts with a mental healthcare counselor at the general practice, is a promising option. The online self-help intervention "Living to the Full"-an Acceptance and Commitment Therapy (ACT) intervention-has been proven to reduce depression and anxiety in several patient groups, but has not yet been investigated in older adults. The aim of this study is to evaluate the (cost-)effectiveness of a blended form of "Living to the Full" in reducing anxiety symptoms in adults aged 55 to 75 years. Furthermore, moderators and mediators of the treatment effect are investigated. METHODS/DESIGN: The (cost-)effectiveness of the ACT intervention will be investigated in a cluster single-blind randomized controlled trial (RCT). The blended intervention will be compared to treatment-as-usual. Thirty-six mental health counselors working at general practices in the Netherlands will be randomized to deliver blended care or treatment as usual. A total of 240 participants (aged 55-75 years) with mild to moderately severe anxiety complaints (defined as a total score of 5-15 on the GAD-7) will be recruited. There are four measurements consisting of online questionnaires (primary outcome: GAD-7) and a telephone interview: before the start of the intervention; directly following the intervention (14 weeks after baseline); and six and twelve months after baseline. Possible mediator variables will be assessed multiple times basis during the intervention. DISCUSSION: This RCT will evaluate the effectiveness of a blended ACT intervention for older adults with anxiety symptoms. If the intervention is shown to be effective, it will be implemented, thereby improving the accessibility and quality of preventive interventions for older adults with anxiety problems. TRIAL REGISTRATION: Netherlands Trial Register, NTR6270 . Registered on 21 March 2017.

Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

BACKGROUND: Depression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT. METHODS: The study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis. DISCUSSION: This study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services. TRIAL REGISTRATION: Current Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124 . Web: http://www.isrctn.com/ISRCTN91967124 . Clinicaltrials.gov : NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to Activity Management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): protocol for a randomised controlled trial.

BACKGROUND: Paediatric chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is a relatively common and disabling condition. The National Institute for Health and Clinical Excellence (NICE) recommends Cognitive Behavioural Therapy (CBT) as a treatment option for paediatric CFS/ME because there is good evidence that it is effective. Despite this, most young people in the UK are unable to access local specialist CBT for CFS/ME. A randomised controlled trial (RCT) showed FITNET was effective in the Netherlands but we do not know if it is effective in the National Health Service (NHS) or if it is cost-effective. This trial will investigate whether FITNET-NHS is clinically effective and cost-effective in the NHS. METHODS: Seven hundred and thirty-four paediatric patients (aged 11-17 years) with CFS/ ME will be randomised (1:1) to receive either FITNET-NHS (online CBT) or Activity Management (delivered via video call). The internal pilot study will use integrated qualitative methods to examine the feasibility of recruitment and the acceptability of treatment. The full trial will assess whether FITNET-NHS is clinically effective and cost-effective. The primary outcome is disability at 6 months, measured using the SF-36-PFS (Physical Function Scale) questionnaire. Cost-effectiveness is measured via cost-utility analysis from an NHS perspective. Secondary subgroup analysis will investigate the effectiveness of FITNET-NHS in those with co-morbid mood disorders. DISCUSSION: If FITNET-NHS is found to be feasible and acceptable (internal pilot) and effective and cost-effective (full trial), its provision by the NHS has the potential to deliver substantial health gains for the large number of young people suffering from CFS/ME but unable to access treatment because there is no local specialist service. This trial will provide further evidence evaluating the delivery of online CBT to young people with chronic conditions. TRIAL REGISTRATION: ISRCTN registry, registration number: ISRCTN18020851 . Registered on 4 August 2016.

The Methodological Quality and Effectiveness of Technology-Based Smoking Cessation Interventions for Disadvantaged Groups: A Systematic Review and Meta-analysis.

Aims: To assess the methodological quality and effectiveness of technology-based smoking cessation interventions in disadvantaged groups. Method: Four databases (EMBASE, Cochrane, Medline, and PsycInfo) were searched for studies conducted from 1980 to May 2016. Randomized controlled trials that compared a behavioral smoking cessation intervention delivered primarily through a technology-based platform (eg, mobile phone) with a no-intervention comparison group among disadvantaged smokers were included. Three reviewers assessed all relevant studies for inclusion, and one reviewer extracted study, participant and intervention-level data, with a subset crosschecked by a second reviewer. Results: Thirteen studies targeting disadvantaged smokers (n =4820) were included. Only one study scored highly in terms of methodological rigor on EPOC criteria for judging risk of bias. Of the 13 studies using a technology-based platform, most utilized websites (n = 5) or computer programs (n = 5), and seven additionally offered nicotine replacement therapy. Technology-based interventions increased the odds of smoking cessation for disadvantaged groups at 1 month (odds ratio [OR] 1.70, 95% confidence interval [CI] 1.10, 2.63), 3 months (OR 1.30, 95% CI 1.07, 1.59), 6 months (OR 1.29, 95% CI 1.03, 1.62), and 18 months post-intervention (OR 1.83, 95% CI 1.11, 3.01). Conclusion: Few methodologically rigorous studies were identified. Mobile phone text-messaging, computer- and website-delivered quit support showed promise at increasing quit rates among Indigenous, psychiatric and inpatient substance use disorder patients. Further research is needed to address the role technology-based interventions have on overcoming health inequalities to meet the needs of disadvantaged groups. Implications: This review provides the first quantitative evidence of the effectiveness of a range of technology-based smoking cessation interventions among disadvantaged smokers, with separate estimates on the basis of intervention type, and cessation outcome measure. Providing cost-effective, easily accessible and real-time smoking cessation treatment is needed, and innovative technology-based platforms will help reach this endpoint. These interventions need to be tested in larger scale randomized controlled trial designs and target broader disadvantaged groups. Data collection beyond 6 months is also needed in order to establish the efficacy of these intervention approaches on long-term cessation rates among disadvantaged population groups.

Agency-level financial incentives and electronic reminders to improve continuity of care after discharge from residential treatment and detoxification.

BACKGROUND: Despite the importance of continuity of care after detoxification and residential treatment, many clients do not receive further treatment services after discharged. This study examined whether offering financial incentives and providing client-specific electronic reminders to treatment agencies lead to improved continuity of care after detoxification or residential treatment. METHODS: Residential (N = 33) and detoxification agencies (N = 12) receiving public funding in Washington State were randomized into receiving one, both, or none (control group) of the interventions. Agencies assigned to incentives arms could earn financial rewards based on their continuity of care rates relative to a benchmark or based on improvement. Agencies assigned to electronic reminders arms received weekly information on recently discharged clients who had not yet received follow-up treatment. Difference-in-difference regressions controlling for client and agency characteristics tested the effectiveness of these interventions on continuity of care. RESULTS: During the intervention period, 24,347 clients received detoxification services and 20,685 received residential treatment. Overall, neither financial incentives nor electronic reminders had an effect on the likelihood of continuity of care. The interventions did have an effect among residential treatment agencies which had higher continuity of care rates at baseline. CONCLUSIONS: Implementation of agency-level financial incentives and electronic reminders did not result in improvements in continuity of care, except among higher performing agencies. Alternative strategies at the facility and systems levels should be explored to identify ways to increase continuity of care rates in specialty settings, especially for low performing agencies.

Minimally-invasive dental anesthesia: Patients' preferences and analysis of the willingness-to-pay index.

AIM: The aim of the present prospective study was to evaluate the impact of a computer-controlled anesthesia on patients' comfort and to investigate, through the willingness-to-pay (WTP) index, and patients' acceptance of this new technology. METHODS: Fifty patients undergoing a class I or II restorative procedure were enrolled. A computer-controlled device for anesthetic delivery was utilized, and a questionnaire on the level of discomfort and WTP was given to all patients. RESULTS: A total of 86% of participants declared less discomfort than that perceived during their last traditional procedure for pain control; 58% of patients were willing to pay an additional fee for a modern anesthesia technique, with a median WTP value of 20$. CONCLUSIONS: Computer-controlled systems for local anesthesia represent a relevant tool for reducing patients' discomfort during dental treatment. The WTP index helps to quantify its relevance.

Cognitive Bias Modification for paranoia (CBM-pa): study protocol for a randomised controlled trial.

BACKGROUND: Persecutory delusions are the most common type of delusions in psychosis and present in around 10-15% of the general population. Persecutory delusions are thought to be sustained by biased cognitive and emotional processes. Recent advances favour targeted interventions, focussing on specific symptoms or mechanisms. Our aim is to test the clinical feasibility of a novel psychological intervention, which manipulates biased interpretations toward more adaptive processing, in order to reduce paranoia in patients. METHODS: The 'Cognitive Bias Modification for paranoia' (CBM-pa) study is a feasibility, double-blind, randomised controlled trial (RCT) for 60 stabilised outpatients with persistent, distressing paranoid symptoms. Patients will be randomised at a 50:50 ratio, to computerised CBM-pa or a text-reading control intervention, receiving one 40-min session per week, for 6 weeks. CBM-pa involves participants reading stories on a computer screen, completing missing words and answering questions about each story in a way that encourages more helpful beliefs about themselves and others. Treatment as Usual will continue for patients in both groups. Patients will be assessed by a researcher blind to allocation, at baseline, each interim session, post treatment and 1- and 3-month follow-up post treatment. The primary outcome is the feasibility parameters (trial design, recruitment rate and acceptability) of the intervention. The secondary outcomes are clinical symptoms (including severity of paranoia) as assessed by a clinical psychologist, and 'on-line' measurement of interpretation bias and stress/distress. The trial is funded by the NHS National Institute for Health Research. DISCUSSION: This pilot study will test whether CBM-pa has the potential to be a cost-effective, accessible and flexible treatment. If the trial proves feasible and demonstrates preliminary evidence of efficacy, a fully powered RCT will be warranted. TRIAL REGISTRATION: Current Controlled Trials ISRCTN: 90749868 . Retrospectively registered on 12 May 2016.

Testing the comparative effects of physical activity advice by humans vs. computers in underserved populations: The COMPASS trial design, methods, and baseline characteristics.

While physical inactivity is a key risk factor for a range of chronic diseases and conditions associated with aging, a significant proportion of midlife and older adults remain insufficiently active. This is particularly true for ethnic minority populations such as Latino adults for whom few culturally adapted programs have been developed and tested. The major objective of this 12-month cluster-randomized controlled trial is to test the comparative effectiveness of two linguistically and culturally adapted, community-based physical activity interventions with the potential for broad reach and translation. Ten local community centers serving a sizable number of Latino residents were randomized to receive one of two physical activity interventions. The Virtual Advisor program employs a computer-based embodied conversational agent named "Carmen" to deliver interactive, individually tailored physical activity advice and support. A similar intervention program is delivered by trained Peer Advisors. The target population consists of generally healthy, insufficiently active Latino adults ages 50years and older living within proximity to a designated community center. The major outcomes are changes in walking and other forms of physical activity measured via self-report and accelerometry. Secondary outcomes include physical function and well-being variables. In addition to these outcome analyses, comparative cost analysis of the two programs, potential mediators of intervention success, and baseline moderators of intervention effects will be explored to better determine which subgroups do best with which type of intervention. Here we present the study design and methods, including recruitment strategies and yield as well as study baseline characteristics. TRIAL REGISTRATION: clinicaltrial.gov Identifier=NCT02111213.

Computer-assisted cognitive remediation therapy in schizophrenia: Durability of the effects and cost-utility analysis.

The durability of computer-assisted cognitive remediation (CACR) therapy over time and the cost-effectiveness of treatment remains unclear. The aim of the current study is to investigate the effectiveness of CACR and to examine the use and cost of acute psychiatric admissions before and after of CACR. Sixty-seven participants were initially recruited. For the follow-up study a total of 33 participants were enrolled, 20 to the CACR condition group and 13 to the active control condition group. All participants were assessed at baseline, post-therapy and 12 months post-therapy on neuropsychology, QoL and self-esteem measurements. The use and cost of acute psychiatric admissions were collected retrospectively at four assessment points: baseline, 12 months post-therapy, 24 months post-therapy, and 36 months post-therapy. The results indicated that treatment effectiveness persisted in the CACR group one year post-therapy on neuropsychological and well-being outcomes. The CACR group showed a clear decrease in the use of acute psychiatric admissions at 12, 24 and 36 months post-therapy, which lowered the global costs the acute psychiatric admissions at 12, 24 and 36 months post-therapy. The CACR is durable over at least a 12-month period, and CACR may be helping to reduce health care costs for schizophrenia patients.

The cost-effectiveness of a web-based multimodal therapy for unilateral cerebral palsy: the Mitii randomized controlled trial.

AIM: To estimate the cost-effectiveness of the Mitii training system for improvements in upper limb function for children with unilateral cerebral palsy (CP). Mitii is a web-based programme delivered at home with set-up and monitoring by therapists. METHOD: A randomized controlled trial was conducted comparing the Mitii training programme to usual care. The Assessment of Motor and Process Skills (AMPS) and Canadian Occupational Performance Measure (COPM) were collected for each child at baseline and 20 weeks. Responders to training were characterized as those who met a minimally important difference on either the AMPS (0.3 logits) or COPM (2 points). Costs of the intervention were calculated by quantifying the equipment and staff cost. A cost per responder was calculated for each of the outcome measures. RESULTS: A total of 102 participants (52 males, 50 females) were included in the analysis. There were significantly more responders in the training group on both the AMPS motor and process scales and the COPM performance and satisfaction scales. The cost per responder for the Mitii programme ranged from AU$3078 to AU$4191 depending on the scale used. INTERPRETATION: The cost of delivering the Mitii training system is modest relative to the improvements in function.

Cost-effectiveness of computerized cognitive-behavioural therapy for the treatment of depression in primary care: findings from the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy (REEACT) trial.

BACKGROUND: Computerized cognitive-behavioural therapy (cCBT) forms a core component of stepped psychological care for depression. Existing evidence for cCBT has been informed by developer-led trials. This is the first study based on a large independent pragmatic trial to assess the cost-effectiveness of cCBT as an adjunct to usual general practitioner (GP) care compared with usual GP care alone and to establish the differential cost-effectiveness of a free-to-use cCBT programme (MoodGYM) in comparison with a commercial programme (Beating the Blues) in primary care. METHOD: Costs were estimated from a healthcare perspective and outcomes measured using quality-adjusted life years (QALYs) over 2 years. The incremental cost-effectiveness of each cCBT programme was compared with usual GP care. Uncertainty was estimated using probabilistic sensitivity analysis and scenario analyses were performed to assess the robustness of results. RESULTS: Neither cCBT programme was found to be cost-effective compared with usual GP care alone. At a £20 000 per QALY threshold, usual GP care alone had the highest probability of being cost-effective (0.55) followed by MoodGYM (0.42) and Beating the Blues (0.04). Usual GP care alone was also the cost-effective intervention in the majority of scenario analyses. However, the magnitude of the differences in costs and QALYs between all groups appeared minor (and non-significant). CONCLUSIONS: Technically supported cCBT programmes do not appear any more cost-effective than usual GP care alone. No cost-effective advantage of the commercially developed cCBT programme was evident compared with the free-to-use cCBT programme. Current UK practice recommendations for cCBT may need to be reconsidered in the light of the results.