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Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive-Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome.

ABSTRACT: Background: There is a growing interest in using group cognitive-behavioral therapy (CBT) with people who have Asperger syndrome (AS) and comorbid mental health problems. This study aims to assess the cost-effectiveness of modified group CBT for adults with AS experiencing co-occurring anxiety compared to treatment-as-usual. Methods: Economic evaluation alongside a pilot, multicenter, single-blind, randomized controlled crossover trial. Costs from the UK public sector (National Health Service and Social Services) and societal perspectives, quality-adjusted life years (QALYs), incremental net (monetary) benefit (INB), expected value of perfect information, expected value of sample information, expected net gain of sampling, and efficient sample size of a future trial are reported. Results: Over 48 weeks, from the societal perspective, CBT results in additional costs of £6,647, with only a 0.015 incremental gain in QALYs, leading to a negative INB estimate of £6,206 and a 23% probability of cost-effectiveness at a threshold of £30,000/QALY. Results from sensitivity analyses support the unlikely cost-effectiveness of CBT but indicate the potential for cost-effectiveness over longer time horizons. Eliminating decision uncertainty is valued at £277 million, and the efficient sample size for a future trial is estimated at 1,200 participants per arm. Limitations: Relatively small sample size and prevalence of missing data present challenges to the interpretation of the results. Conclusions: Current evidence from this small pilot study suggests that, on average, modified group CBT is not cost-effective. However, there is much decision uncertainty so such a conclusion could be wrong. A large, full-scale trial to reduce uncertainty would be an efficient investment for the UK health economy.

SUBMITTER: Doble B

PROVIDER: S-EPMC6125049 | biostudies-literature | 2017 Jul-Dec

REPOSITORIES: biostudies-literature

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Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive-Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome.

Doble Brett B Langdon Peter E PE Shepstone Lee L Murphy Glynis H GH Fowler David D Heavens David D Malovic Aida A Russell Alexandra A Rose Alice A Mullineaux Louise L Wilson Edward C F ECF

MDM policy & practice 20170701 2

<b>Background:</b> There is a growing interest in using group cognitive-behavioral therapy (CBT) with people who have Asperger syndrome (AS) and comorbid mental health problems. This study aims to assess the cost-effectiveness of modified group CBT for adults with AS experiencing co-occurring anxiety compared to treatment-as-usual. <b>Methods:</b> Economic evaluation alongside a pilot, multicenter, single-blind, randomized controlled crossover trial. Costs from the UK public sector (National Hea ...[more]

PMID: 30288430

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Project description:IntroductionA number of studies have established that children, adolescents and adults with Asperger syndrome (AS) and high functioning autism (HFA) have significant problems with anxiety. Cognitive behavioural therapy (CBT) is an effective treatment for anxiety in a variety of clinical populations. There is a growing interest in exploring the effectiveness of CBT for people with AS who have mental health problems, but currently there are no known clinical trials involving adults with AS or HFA. Studies with children who have AS have reported some success. The current study aims to examine whether modified group CBT for clinically significant anxiety in an AS population is likely to be efficacious.Methods and analysisThis study is a randomised, single-blind crossover trial. At least 36 individuals will be recruited and randomised into a treatment arm or a waiting-list control arm. During treatment, individuals will receive 3 sessions of individual CBT, followed by 21 sessions of group CBT. Primary outcome measures focus on anxiety. Secondary outcome measures focus on everyday social and psychiatric functioning, additional measures of anxiety and fear, depression, health-related quality of life and treatment cost. Assessments will be administered at pregroup and postgroup and at follow-up by researchers who are blinded to group allocation. The trial aims to find out whether or not psychological treatments for anxiety can be adapted and used to successfully treat the anxiety experienced by people with AS. Furthermore, we aim to determine whether this intervention represents good value for money.Ethics and disseminationThe trial received a favourable ethical opinion from a National Health Service (NHS) Research Ethics Committee. All participants provided written informed consent. Findings will be shared with all trial participants, and the general public, as well as the scientific community.Trial registrationISRCTN 30265294 (DOI: 10.1186/ISRCTN30265294), UKCRN 8370.

Project description:OBJECTIVE:To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. DESIGN:A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. SETTING:Occupational health care in the Netherlands. PARTICIPANTS:Employees from small-sized and medium-sized companies (?18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. INTERVENTIONS:In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. OUTCOMES MEASURES:Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. RESULTS:From the employer's perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee's perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier's perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. CONCLUSIONS:The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a single year. The sometimes wide 95% CIs suggest that the costs and benefits are not always very precise estimates and real benefits could vary considerably. TRIAL REGISTRATION:NTR2108; Results.

Project description:BackgroundMinor ailments are "self-limiting conditions which may be diagnosed and managed without a medical intervention". A cluster randomised controlled trial (cRCT) was designed to evaluate the clinical, humanistic and economic outcomes of a Minor Ailment Service (MAS) in community pharmacy (CP) compared with usual care (UC).MethodsThe cRCT was conducted for 6 months from December 2017. The pharmacist-patient intervention consisted of a standardised face-to-face consultation on a web-based program using co-developed protocols, pharmacists' training, practice change facilitators and patients' educational material. Patients requesting a non-prescription medication (direct product request) or presenting minor ailments received MAS or UC and were followed-up by telephone 10-days after the consultation. The primary economic outcomes were incremental cost-utility ratio (ICUR) of the service and health related quality of life (HRQoL). Total costs included health system, CPs and patient direct costs: health professionals' consultation time, medication costs, pharmacists' training costs, investment of the pharmacy and consultation costs within the 10 days following the initial consultation. The HRQoL was obtained using the EuroQoL 5D-5L at the time of the consultation and at 10-days follow up. A sensitivity analysis was carried out using bootstrapping. There were two sub-group analyses undertaken, for symptom presentation and direct product requests, to evaluate possible differences.ResultsA total of 808 patients (323 MAS and 485 UC) were recruited in 27 CPs with 42 pharmacists (20 MAS and 22 UC). 64.7% (n = 523) of patients responded to follow-up after their consultation in CP. MAS patients gained an additional 0.0003 QALYs (p = 0.053). When considering only MAS patients presenting with symptoms, the ICUR was 24,733€/QALY with a 47.4% probability of cost-effectiveness (willingness to pay of 25,000€/QALY). Although when considering patients presenting for a direct product request, MAS was the dominant strategy with a 93.69% probability of cost-effectiveness.ConclusionsExpanding community pharmacists' scope through MAS may benefit health systems. To be fully cost effective, MAS should not only include consultations arising from symptom presentation but also include an oversight of self-selected products by patients. MAS increase patient safety through the appropriate use of non-prescription medication and through the direct referral of patients to GP.Trial registrationISRCTN, ISRCTN17235323 . Registered 07/05/2021 - Retrospectively registered.

Project description:Importance:Brief cognitive behavioral therapy (BCBT) is a clinically effective intervention for reducing risk of suicide attempts among suicidal US Army soldiers. However, because specialized treatments can be resource intensive, more information is needed on costs and benefits of BCBT compared with existing treatments. Objective:To evaluate the cost-effectiveness of BCBT compared with treatment as usual for suicidal soldiers in the US Army. Design, Setting, and Participants:A decision analytic model compared effects and costs of BCBT vs treatment as usual from a US Department of Defense (DoD) perspective. Model input data were drawn from epidemiologic data sets and a clinical trial among suicidal soldiers conducted from January 31, 2011, to April 3, 2014. Data were analyzed from July 3, 2018, to March 25, 2019. Interventions:The strategies compared were treatment as usual alone vs treatment as usual plus 12 individual BCBT sessions. Treatment as usual could include a range of pharmacologic and psychological treatment options. Main Outcomes and Measures:Costs in 2017 US dollars, suicide attempts averted (self-directed behavior with intent to die, but with nonfatal outcome), suicide deaths averted, and incremental cost-effectiveness ratios, assuming a 2-year time horizon for treatment differences but including lifetime costs. Results:In the base-case analysis, BCBT was expected to avert approximately 23 to 25 more suicide attempts and 1 to 3 more suicide deaths per 100 patients treated than treatment as usual. Sensitivity analyses assuming a range of treatment effects showed BCBT to be cost saving in most scenarios. Using the federal discount rate, the DoD was estimated to save from $15?000 to $16?630 per patient with BCBT vs treatment as usual. In a worst-case scenario (ie, assuming the weakest plausible BCBT effect sizes), BCBT cost an additional $1910 to $2250 per patient compared with treatment as usual. Conclusions and Relevance:Results suggest BCBT may be a cost-saving intervention for suicidal active-duty soldiers. The costs of ensuring treatment fidelity would also need to be considered when assessing the implications of disseminating BCBT across the entire DoD.

Project description:BackgroundDepression and anxiety frequently coexist with chronic musculoskeletal pain and can negatively impact patients' responses to standard orthopedic treatments. Nevertheless, mental health is not routinely addressed in the orthopedic care setting. If effective, a digital mental health intervention may be a feasible and scalable method of addressing mental health in an orthopedic setting.ObjectiveWe aimed to compare 2-month changes in mental and physical health between orthopedic patients who received a digital mental health intervention in addition to usual orthopedic care, those who received usual orthopedic care only (without a specific mental health intervention), and those who received in-person care with a psychologist as part of their orthopedic treatment plan.MethodsIn this single-center retrospective cohort study involving ancillary analysis of a pilot feasibility study, 2-month self-reported health changes were compared between a cohort of orthopedic patients who received access to a digital mental health intervention (Wysa) and 2 convenience sample comparison cohorts (patients who received usual orthopedic care without a specific mental health intervention and patients who received in-person care with a psychologist as part of their orthopedic treatment plan). All patients were 18 years or older and reported elevated symptoms of depression or anxiety at an orthopedic clinic visit (Patient-Reported Outcomes Measurement Information System [PROMIS] Depression or Anxiety score ≥55). The digital intervention was a multi-component mobile app that used chatbot technology and text-based access to human counselors to provide cognitive behavioral therapy, mindfulness training, and sleep tools, among other features, with an emphasis on behavioral activation and pain acceptance. Outcomes of interest were between-cohort differences in the 2-month longitudinal changes in PROMIS Depression and Anxiety scores (primary outcomes) and PROMIS Pain Interference and Physical Function scores (secondary outcomes).ResultsAmong 153 patients (mean age 55, SD 15 years; 128 [83.7%] female; 51 patients per cohort), patients who received the digital mental health intervention showed clinically meaningful improvements at the 2-month follow-up for all PROMIS measures (mean longitudinal improvement 2.8-3.7 points; P≤.02). After controlling for age and BMI, the improvements in PROMIS Depression, Pain Interference, and Physical Function were meaningfully greater than longitudinal changes shown by patients who received usual orthopedic care (mean between-group difference 2.6-4.8 points; P≤.04). Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04).ConclusionsPatients who received a digital mental health intervention as part of orthopedic care reported greater 2-month mean improvements in depression, pain interference, and physical function than patients who received usual orthopedic care. They also reported a greater mean improvement in physical function and comparable improvements in depression, anxiety, and pain interference compared with orthopedic patients who received in-person psychological counseling.

Project description:ObjectivesThis study investigated the effectiveness of a group-based 8-week intervention, Mindfulness-integrated Cognitive Behavior Therapy (MiCBT), to decrease psychological distress and increase wellbeing in a heterogeneous population in primary health care. MiCBT focuses on the importance of interoception and its interaction with cognition in emotional experience. These interactions are represented in the co-emergence model of reinforcement, in which non-reactivity (equanimity) to interoceptive signals facilitates adaptive behavior.MethodsParticipants (n = 125, aged 20-72) were randomized to two groups (MiCBT), and treatment-as-usual (TAU). Outcomes were assessed at pre-, mid-, and post-intervention and at 6-month follow-up. The primary outcome was psychological distress, measured by the Depression, Anxiety and Stress Scale (DASS-21). Secondary outcome measures were the Kessler Psychological Distress Scale-10 (K10), Satisfaction with Life Scale (SWLS), and Flourishing Scale (FS). Mediator or process measures of interoceptive awareness, metacognitive awareness (decentering), equanimity, and social functioning were included to investigate putative mediators.ResultsThe MiCBT intervention significantly reduced DASS-21 scores at mid and post-treatment and the gains were maintained at 6-month follow-up (p < 0.0001, d = 0.38). Flourishing scores also showed significant improvement post-treatment and at 6-month follow-up (d = 0.24, p < 0.0001). All measures selected showed a similar pattern of positive change, with the exception of the SWLS, which failed to reach significance. Mediation analysis suggested equanimity to be the most influential mediator of the primary outcome.ConclusionsThe results support the effectiveness of MiCBT in creating rapid and sustainable reduction of psychological distress and improvement in flourishing in a primary mental health care setting with heterogenous groups. These promising results support the scaled-up implementation of this intervention.Clinical trial registrationThis trial is registered with the Australian and New Zealand Clinical Trial Registry: https://www.anzctr.org.au/ACTRN12617000061336.

Dataset Information

Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive-Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome.

Publications

Economic Evaluation Alongside a Randomized Controlled Crossover Trial of Modified Group Cognitive-Behavioral Therapy for Anxiety Compared to Treatment-as-Usual in Adults With Asperger Syndrome.

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