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Cost-effectiveness of internet-delivered cognitive-behavioural therapy for adolescents with irritable bowel syndrome.

ABSTRACT: OBJECTIVE:To assess whether exposure-based internet-delivered cognitive-behavioural therapy (internet-CBT) is a cost-effective treatment for adolescents with irritable bowel syndrome (IBS) compared with a waitlist control, from a societal perspective, based on data from a randomised trial. DESIGN:Within-trial cost-effectiveness analysis. SETTING:Participants were recruited from the whole of Sweden via primary, secondary and tertiary care clinics reached through news media and advertising. PARTICIPANTS:Adolescents (aged 13-17) with a diagnosis of IBS. INTERVENTIONS:Participants were randomised to either an exposure-based internet-CBT, including 10 weekly modules for adolescents and five modules for parents, or a waitlist. OUTCOME MEASURES:The main health outcome was the quality-adjusted life-year (QALY) estimated by mapping Pediatric Quality-of-Life Inventory (PedsQL) scores onto EQ-5D-3L utilities. The secondary outcome was the point improvement on the PedsQL scale. Data on health outcomes and resource use were collected at baseline and 10 weeks post-treatment. Resource use was measured using the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P) . Incremental cost-effectiveness ratios (ICER) were calculated as the difference in average costs by the difference in average outcomes between groups. RESULTS:The base-case results showed that internet-CBT costs were on average US$170.24 (95% CI 63.14 to 315.04) more per participant than the waitlist. Adolescents in the internet-CBT group showed small QALY gains (0.0031; 95%?CI 0.0003 to 0.0061), and an average improvement of 5.647 points (95%?CI 1.82 to 9.46) on the PedsQL compared with the waitlist. Internet-CBT yielded an ICER of $54 916/QALY gained and a probability of cost-effectiveness of 74% given the Swedish willingness-to-pay threshold. The ICER for the outcome PedsQL was US$85.29/point improvement. CONCLUSIONS:Offering internet-CBT to adolescents with IBS improves health-related quality of life and generates small QALY gains at a higher cost than a waitlist control. Internet-CBT is thus likely to be cost-effective given the strong efficacy evidence, small QALY gains and low cost. TRIAL REGISTRATION NUMBER:NCT02306369; Results.

SUBMITTER: Sampaio F

PROVIDER: S-EPMC6347900 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Internet-based cognitive behavior therapy (ICBT) has shown promising effects in the treatment of irritable bowel syndrome (IBS). However, to date no study has used a design where participants have been sampled solely from a clinical population. We aimed to investigate the acceptability, effectiveness, and cost-effectiveness of ICBT for IBS using a consecutively recruited sample from a gastroenterological clinic. METHODS:Sixty-one patients were randomized to 10 weeks of ICBT (n = 30) or a waiting list control (n = 31). The ICBT was guided by an online therapist and emphasized acceptance of symptoms through exposure and mindfulness training. Severity of IBS symptoms was measured with the Gastrointestinal symptom rating scale--IBS version (GSRS-IBS). Patients in both groups were assessed at pre- and post-treatment while only the ICBT group was assessed 12 months after treatment completion. Health economic data were also gathered at all assessment points and analyzed using bootstrap sampling. RESULTS:Fifty of 61 patients (82%) completed the post-treatment assessment and 20 of 30 patients (67%) in the ICBT group were assessed at 12-month follow-up. The ICBT group demonstrated significantly (p < .001) larger improvements on the IBS-related outcome scales than the waiting list group. The between group effect size on GSRS-IBS was Cohen's d = 0.77 (95% CI: 0.19-1.34). Similar effects were noted on measures of quality of life and IBS-related fear and avoidance behaviors. Improvements in the ICBT group were maintained at 12-month follow-up. The ICBT condition was found to be more cost-effective than the waiting list, with an 87% chance of leading to reduced societal costs combined with clinical effectiveness. The cost-effectiveness was sustained over the 12-month period. CONCLUSIONS:ICBT proved to be a cost-effective treatment when delivered to a sample recruited from a gastroenterological clinic. However, many of the included patients dropped out of the study and the overall treatment effects were smaller than previous studies with referred and self-referred samples. ICBT may therefore be acceptable and effective for only a subset of clinical patients. Study dropout seemed to be associated with severe symptoms and large impairment. Objective and empirically validated criteria to select which patients to offer ICBT should be developed. TRIAL REGISTRATION:ClinicalTrials.gov: NCT00844961.

Project description:ImportanceTherapist-guided, internet-delivered cognitive behavioral therapy is an effective treatment option for children and adolescents with obsessive-compulsive disorder, but to our knowledge, its cost-effectiveness compared with traditional in-person treatment has not been established.ObjectiveTo evaluate the cost-effectiveness of guided internet-delivered cognitive behavioral therapy implemented within a stepped-care model compared with in-person cognitive behavioral therapy for young people with obsessive-compulsive disorder.Design, setting, and participantsThis economic evaluation of a randomized noninferiority trial conducted at 2 specialist obsessive-compulsive disorder clinics in Sweden enrolled 152 children and adolescents aged 8 to 17 years with obsessive-compulsive disorder, mainly through clinician referrals (110 [72%]). Recruitment began October 6, 2017, and ended May 24, 2019. Follow-up ended April 14, 2020.InterventionsParticipants were randomly assigned to receive either guided internet-delivered cognitive behavioral therapy or in-person cognitive behavioral therapy during a 16-week period. At the 3-month follow-up, nonresponders in both groups were offered additional in-person cognitive behavior therapy sessions.Main outcomes and measuresHealth outcomes were treatment response rates (primary outcome), remission rates, and quality-adjusted life-years. Cost data were collected before treatment, after treatment, at 3-month follow-up, and at 6-month follow-up (primary end point) and are presented in 2020 US dollars. The differences in incremental costs and health outcomes were compared between the groups and presented from the health care professional, health care sector, and societal perspectives.ResultsA total of 152 participants (94 girls [62%]; mean [SD] age, 13.4 [2.5] years) were randomized; 151 (99%) completed the trial. At the 6-month follow-up, 50 of 74 participants (68%) in the stepped-care group and 52 of 77 participants (68%) in the in-person cognitive behavioral therapy group were classified as treatment responders (odds ratio, 1.00 [95% CI, 0.51-1.98]; P = .99). Health economic analyses showed that the stepped-care group used fewer therapist resources than the in-person cognitive behavioral therapy group, resulting in a mean cost savings of $2104 (95% CI, $1202-$3006) per participant for the full study period of 10 months, corresponding to a relative savings of 39%. The cost savings remained largely comparable when taking wider health care sector and societal perspectives.Conclusions and relevanceThis study suggests that, for young people with obsessive-compulsive disorder, a low-cost digital intervention followed by in-person treatment for nonresponders was cost-effective compared with in-person cognitive behavior therapy alone.

Project description:BackgroundIrritable bowel syndrome (IBS) is a debilitating and costly disorder. Cognitive behavior therapy (CBT) is effective in the treatment of IBS, both when delivered over the internet and in face-to-face settings. CBT consists of different components and little is known about their relative importance. We have in an earlier study showed that inclusion of exposure in the CBT for IBS makes it even more effective. In the present study we wanted to evaluate the economic effects for society of inclusion vs exclusion of exposure in an internet delivered CBT for IBS.MethodsWe used data from a previous study with 309 participants with IBS. Participants were randomized to internet delivered CBT with (ICBT) or without exposure (ICBT-WE). We compared direct and indirect costs at baseline, after treatment, and 6 months after treatment (primary endpoint; 6MFU). Data was also collected on symptom severity and time spent by therapists and participants. The relative Incremental Cost Effectiveness Ratio (ICER) was calculated for the two treatment conditions and the return on investment (ROI).ResultsResults showed that ICBT cost $213.5 (20%) more than ICBT-WE per participant. However, ICBT was associated with larger reductions regarding both costs and symptoms than ICBT-WE at 6MFU. The ICER was - 301.69, meaning that for every point improvement on the Gastrointestinal Symptom Rating Scale-IBS version in ICBT, societal costs would be reduced with approximately $300. At a willingness to pay for a case of clinically significant improvement in IBS symptoms of $0, there was an 84% probability of cost-effectiveness. ROI analysis showed that for every $1 invested in ICBT rather than ICBT-WE, the return would be $5.64 six months after treatment. Analyses of post-treatment data showed a similar pattern although cost-savings were smaller.ConclusionsIncluding exposure in Cognitive Behavior Treatment for IBS is more cost-effective from a societal perspective than not including it, even though it may demand more therapist and patient time in the short term.Trial registrationThis study is reported in accordance with the CONSORT statement for non-pharmacological trials [1]. Clinicaltrials.gov registration ID: NCT01529567 (14/02/2013).

Project description:IntroductionIrritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic.Methods and analysisA mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis.Ethics and disseminationThis study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee.Trial registration number isrctn83683687 (http://www.controlled-trials.com/ISRCTN83683687).

Project description:BACKGROUND & AIMS:Diagnosis of diarrhea-predominant irritable bowel syndrome (IBS-D) relies on the Rome IV symptom-based criteria, which are imperfect for separating functional vs organic disease. Biomarker tests for IBS-D might be added to symptom data to allow clinicians to make more accurate and precise diagnoses in a cost-effective manner. We tested the economic consequences of using a range of hypothetical IBS-D biomarkers, and explored at what cost and level of accuracy a biomarker becomes cost effective. We produced a framework for payers to evaluate the return on an investment of implementing IBS-D biomarkers of varying accuracy and cost. METHODS:We used decision analysis software to evaluate a hypothetical cohort of patients who met Rome IV criteria for IBS-D. We conducted cost-utility and budget impact analyses of 2 competing approaches: usual care or an IBS biomarker-based diagnostic approach. Patients in the usual care group received empiric IBS treatment; non-responders received additional diagnostic tests for organic disease. In the group evaluated with a biomarker test, those with a positive result received IBS treatment before additional diagnostic analyses, whereas patients with a negative result underwent upfront diagnostic testing. Outcomes were incremental cost per quality-adjusted life year gained (third-party payer perspective) and incremental per-member per-month cost. RESULTS:In the base-case analysis, using a willingness-to-pay threshold of $100,000/quality-adjusted life year, we found that biomarkers are not cost effective when the biomarker test costs more than $846, even if the test is 100% accurate in detecting IBS-D. In probabilistic analysis using 1,000 simulations, most trials (75% or more) show that the biomarker-based diagnostic approach is cost effective above the following accuracy thresholds: a $100 biomarker test with 51% accuracy, a $200 test with 57% accuracy, a $300 test with 63% accuracy, a $400 test with 69% accuracy, a $500 test with 76% accuracy, a $600 test with 82% accuracy, a $700 test with 89% accuracy, and a $800 test with 94% accuracy. CONCLUSIONS:In decision analysis of a hypothetical cohort of patients who met Rome IV criteria for IBS-D, we identified cost and accuracy thresholds that can guide investigators and payers as they develop, validate, price, and/or reimburse IBS-D biomarker tests for use in everyday clinical practice.

Project description:ObjectivesInternet-delivered exposure-based cognitive behaviour therapy (ICBT) has been shown to be effective in the treatment of severe health anxiety. The health economic effects of the treatment have, however, been insufficiently studied and no prior study has investigated the effect of ICBT compared with an active psychological treatment. The aim of the present study was to investigate the cost effectiveness of ICBT compared with internet-delivered behavioural stress management (IBSM) for adults with severe health anxiety defined as Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) hypochondriasis. ICBT was hypothesised to be the more cost-effective treatment.SettingThis was a cost-effectiveness study within the context of a randomised controlled trial conducted in a primary care/university setting. Participants from all of Sweden could apply to participate.ParticipantsSelf-referred adults (N=158) with a principal diagnosis of DSM-IV hypochondriasis, of whom 151 (96%) provided baseline and post-treatment data.InterventionsICBT or IBSM for 12 weeks.Primary and secondary measuresThe primary outcome was the Health Anxiety Inventory. The secondary outcome was the EQ-5D. Other secondary measures were used in the main outcome study but were not relevant for the present health economic analysis.ResultsBoth treatments led to significant reductions in gross total costs, costs of healthcare visits, direct non-medical costs and costs of domestic work cutback (p=0.000-0.035). The incremental cost-effectiveness ratio (ICER) indicated that the cost of one additional case of clinically significant improvement in ICBT compared with IBSM was $2214. The cost-utility ICER, that is, the cost of one additional quality-adjusted life year, was estimated to be $10,000.ConclusionsICBT is a cost-effective treatment compared with IBSM and treatment costs are offset by societal net cost reductions in a short time. A cost-benefit analysis speaks for ICBT to play an important role in increasing access to effective treatment for severe health anxiety.Trial registration numberNCT01673035; Results.

Project description:Few studies have evaluated the implementation of ICBT in regular child and adolescent mental health services (CAMHS). This study aimed to explore the acceptability, feasibility, and effectiveness of ICBT for children and adolescents with anxiety disorders and obsessive-compulsive disorder (OCD) within a rural CAMHS. The study also explored outcome predictors and long-term outcomes. Eighty-three participants were consecutively recruited from a non-specialized CAMHS in Region Jämtland Härjedalen in northern Sweden. Therapist-guided ICBT was offered during 12 weeks to children aged 8-17 with an anxiety disorder or OCD. Acceptability and feasibility measures included treatment adherence, treatment satisfaction, and adverse events. The primary outcome measure was the Clinical Global Impression-Severity. Secondary measures of effectiveness included clinician-, self-, and parent-ratings of symptom severity and functional impairment. Assessments were completed at baseline, post-treatment, and three-month follow-up (primary endpoint). A two-year follow up was conducted using medical records. Potential predictors included both patient characteristics and treatment variables. Results indicated that ICBT was both acceptable and feasible according to study measures. Statistically significant improvements were found from baseline to the three-month follow-up on clinician rated severity (B [SE] = -0.92 [0.09]; p < .001), as well as on all secondary measures. Forty-three percent of participants no longer fulfilled criteria for their principal disorder at the three-month follow-up. No serious adverse events were reported. Clinical improvement was highest among children with higher functioning at baseline (B [SE] = -0.05 [0.02]; p < .05). Forty-six percent of participants had been in contact with CAMHS during the two-year follow-up period, mainly for reasons other than their initial diagnosis. Findings suggest that ICBT could be an acceptable and feasible treatment option for young people with anxiety disorders and OCD in rural non-specialized CAMHS settings. Further studies are needed to confirm treatment effectiveness in this setting. Trial registration: NCT02926365.

Project description:OBJECTIVES:Social anxiety disorder (SAD) is one of the most common psychiatric disorders in youth, with a prevalence of about 3%-4% and increased risk of adverse long-term outcomes, such as depression. Cognitive-behavioural therapy (CBT) is considered the first-line treatment for youth with SAD, but many adolescents remain untreated due to limited accessibility to CBT. The aim of this study was to develop and evaluate the feasibility and preliminary efficacy of a therapist-guided internet-delivered CBT treatment, supplemented with clinic-based group exposure sessions (BIP SOFT). DESIGN:A proof-of-concept, open clinical trial with 6-month follow-up. PARTICIPANTS:The trial was conducted at a child and adolescent psychiatric research clinic, and participants (n=30) were 13-17 years old (83% girls) with a principal diagnosis of SAD. INTERVENTION:12 weeks of intervention, consisting of nine remote therapist-guided internet-delivered CBT sessions and three group exposure sessions at the clinic for the adolescents and five internet-delivered sessions for the parents. RESULTS:Adolescents were generally satisfied with the treatment, and the completion rate of internet modules, as well as attendance at group sessions, was high. Post-treatment assessment showed a significant decrease in clinician-rated, adolescent-rated and parent-rated social anxiety (d=1.17, 0.85 and 0.79, respectively), as well as in general self-rated and parent-rated anxiety and depression (d=0.76?and 0.51), compared with pretreatment levels. Furthermore, 47% of participants no longer met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for SAD at post-treatment. At a 6-month follow-up, symptom reductions were maintained, or further improved, and 57% of participants no longer met criteria for SAD. CONCLUSION:Therapist-guided and parent-guided internet-delivered CBT, supplemented with a limited number of group exposure sessions, is a feasible and promising intervention for adolescents with SAD. TRIAL REGISTRATION NUMBER:NCT02576171; Results.

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Cost-effectiveness of internet-delivered cognitive-behavioural therapy for adolescents with irritable bowel syndrome.

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