Economic evaluation of mindfulness group therapy for patients with depression, anxiety, stress and adjustment disorders compared with treatment as usual.

BACKGROUND: A randomised controlled trial found that a structured mindfulness group therapy (MGT) programme was as effective as treatment as usual (mostly cognitive-behavioural therapy) for patients with a diagnosis of depression, anxiety or stress and adjustment disorders in Sweden (ClinicalTrials.gov: NCT01476371). AIMS: To perform a cost-effectiveness analysis of MGT compared with treatment as usual from both a healthcare and a societal perspective for the trial duration (8 weeks). METHOD: The costs from a healthcare perspective included treatment as usual, medication and costs for providing MGT. The societal perspective included costs from the healthcare perspective plus savings from productivity gains for the trial duration. The effectiveness was measured as quality-adjusted life-years (QALY) using the EQ-5D-5L questionnaire and the UK value set. Uncertainty surrounding the incremental costs and effects were estimated using non-parametric bootstrapping with 5000 replications and presented with 95% confidence intervals and cost-effectiveness acceptability curves. RESULTS: The MGT group had significantly lower healthcare and societal costs (mean differences -€115 (95% CI -193 to -36) and -€112 (95% CI -207 to -17), respectively) compared with the control group. In terms of effectiveness, there was no significant difference in QALY gain (mean difference -0.003, 95% CI -0.0076 to 0.0012) between the two groups. CONCLUSIONS: MGT is a cost-saving alternative to treatment as usual over the trial duration from both a healthcare and a societal perspective for patients with a diagnosis of depression, anxiety or stress and adjustment disorders in Sweden.

Group schema-focused therapy enriched with psychomotor therapy versus treatment as usual for older adults with cluster B and/or C personality disorders: a randomized trial.

BACKGROUND: Several types of psychotherapy have been proven successful in the treatment of personality disorders in younger age groups, however studies among older patients are lacking. We developed a group schema-focused therapy (SFT) enriched with psychomotor therapy (PMT) for older adults with cluster B and/or C personality disorders. This paper describes the design of a randomized controlled trial (RCT). We will evaluate the (cost-)effectiveness of this therapy protocol in specialized mental health care. We hypothesize that our treatment program is cost-effective and superior to treatment as usual (TAU) in reducing psychological distress and improving quality of life in older adults treated to specialized mental healthcare. METHODS: A multicenter RCT with a one-year follow-up comparing group schema-focused therapy enriched with psychomotor therapy (group SFT + PMT) and TAU for adults aged 60 years and older who suffer from either a cluster B and/or C personality disorder. The primary outcome is general psychological distress measured with the 53-item Brief Symptom Inventory. Secondary outcomes are the Schema Mode Inventory (118-item version) and the Young Schema Questionnaire. Cost-effectiveness analysis will be performed from a societal perspective with the EuroQol five dimensions questionnaire and structured cost-interviews. DISCUSSION: This study will add to the knowledge of psychotherapy in later life. The study specifically contributes to the evidence on (cost-) effectiveness of group SFT enriched with PMT adapted to the needs of for older adults with cluster b and/or c personality. TRIAL REGISTRATION: Netherlands Trial Register NTR 6621 . Registered on 20 August 2017.

Clinical and cost effectiveness of memory rehabilitation following traumatic brain injury: a pragmatic cluster randomized controlled trial.

OBJECTIVE: To evaluate the clinical and cost effectiveness of a group-based memory rehabilitation programme for people with traumatic brain injury. DESIGN: Multicentre, pragmatic, observer-blinded, randomized controlled trial in England. SETTING: Community. PARTICIPANTS: People with memory problems following traumatic brain injury, aged 18-69 years, able to travel to group sessions, communicate in English, and give consent. INTERVENTIONS: A total of 10 weekly group sessions of manualized memory rehabilitation plus usual care (intervention) vs. usual care alone (control). MAIN MEASURES: The primary outcome was the patient-reported Everyday Memory Questionnaire (EMQ-p) at six months post randomization. Secondary outcomes were assessed at 6 and 12 months post randomization. RESULTS: We randomized 328 participants. There were no clinically important differences in the primary outcome between arms at six-month follow-up (mean EMQ-p score: 38.8 (SD 26.1) in intervention and 44.1 (SD 24.6) in control arms, adjusted difference in means: -2.1, 95% confidence interval (CI): -6.7 to 2.5, p = 0.37) or 12-month follow-up. Objectively assessed memory ability favoured the memory rehabilitation arm at the 6-month, but not at the 12-month outcome. There were no between-arm differences in mood, experience of brain injury, or relative/friend assessment of patient's everyday memory outcomes, but goal attainment scores favoured the memory rehabilitation arm at both outcome time points. Health economic analyses suggested that the intervention was unlikely to be cost effective. No safety concerns were raised. CONCLUSION: This memory rehabilitation programme did not lead to reduced forgetting in daily life for a heterogeneous sample of people with traumatic brain injury. Further research will need to examine who benefits most from such interventions.

Economic evaluation of stepped care for the management of childhood anxiety disorders: Results from a randomised trial.

BACKGROUND: Stepped care has been promoted for the management of mental disorders; however, there is no empirical evidence to support the cost-effectiveness of this approach for the treatment of anxiety disorders in youth. METHOD: This economic evaluation was conducted within a randomised controlled trial comparing stepped care to a validated, manualised treatment in 281 young people, aged 7-17, with a diagnosed anxiety disorder. Intervention costs were determined from therapist records. Administrative data on medication and medical service use were used to determine additional health care costs during the study period. Parents also completed a resource use questionnaire to collect medications, services not captured in administrative data and parental lost productivity. Outcomes included participant-completed quality of life, Child Health Utility - nine-dimension and parent-completed Assessment of Quality of Life - eight-dimension to calculate quality-adjusted life years. Mean costs and quality-adjusted life years were compared between groups at 12-month follow-up. RESULTS: Intervention delivery costs were significantly less for stepped care from the societal perspective (mean difference -$198, 95% confidence interval -$353 to -$19). Total combined costs were less for stepped care from both societal (-$1334, 95% confidence interval -$2386 to $510) and health sector (-$563, 95% confidence interval -$1353 to $643) perspectives but did not differ significantly from the manualised treatment. Youth and parental quality-adjusted life years were not significantly different between groups. Sensitivity analysis indicated that the results were robust. CONCLUSION: For youth with anxiety, this three-step model provided comparable outcomes and total health sector costs to a validated face-to-face programme. However, it was less costly to deliver from a societal perspective, making it an attractive option for some parents. Future economic evaluations comparing various models of stepped care to treatment as usual are recommended.

Cost-utility analysis of meaning-centered group psychotherapy for cancer survivors.

BACKGROUND: Meaning-centered group psychotherapy for cancer survivors (MCGP-CS) improves meaning, psychological well-being, and mental adjustment to cancer and reduces psychological distress. This randomized controlled trial was conducted to investigate the cost-utility of MCGP-CS compared with supportive group psychotherapy (SGP) and care-as-usual (CAU). METHODS: In total, 170 patients were randomized to MCGP-CS, SGP, or CAU. Intervention costs, direct medical and nonmedical costs, productivity losses, and health-related quality of life were measured until 6 months follow-up, using the TIC-P, PRODISQ, data from the hospital information system, and the EQ-5D. The cost-utility was calculated by comparing mean cumulative costs and quality-adjusted life years (QALYs). RESULTS: Mean total costs ranged from €4492 (MCGP-CS) to €5304 (CAU). Mean QALYs ranged .507 (CAU) to .540 (MCGP-CS). MCGP-CS had a probability of 74% to be both less costly and more effective than CAU, and 49% compared with SGP. Sensitivity analyses showed these findings are robust. If society is willing to pay €0 for one gained QALY, MCGP-CS has a 78% probability of being cost-effective compared with CAU. This increases to 85% and 92% at willingness-to-pay thresholds of €10 000 and €30 000, which are commonly accepted thresholds. CONCLUSIONS: MCGP-CS is highly likely a cost-effective intervention, meaning that there is a positive balance between the costs and gains of MCGP-CS, in comparison with SGP and CAU.

The Cost-Effectiveness of Cognitive-Behavioral Group Training for Patients with Unexplained Physical Symptoms.

OBJECTIVE: The aim of the study was to evaluate the cost-effectiveness of a cognitive-behavioral group training compared with a wait-list control for patients with unexplained physical symptoms (UPS). METHODS: A probabilistic decision-analytic Markov model was developed with three health states (poor health, average health, and death) based on a cutoff score of the Physical Component Summary of the short-form 36 health survey. To assess the cost-effectiveness in terms of cost per quality-adjusted life-year (QALY), a societal perspective was adopted. The model consisted of cycles of 3 months and a time horizon of 4 years. Data for the model were derived from a randomized controlled trial, in which 162 patients with UPS were randomized either to cognitive-behavioral group training or to the wait-list control. Data were assessed at baseline and after the training of 3 months or after a wait-list period of 3 months. In addition, the training group was followed in an uncontrolled phase and assessed at 3 months and 1 year after the training. RESULTS: After 4 years, the group training was in terms of cost-effectiveness "dominant" compared with the wait-list control; there was a positive effect of 0.06 QALYs and a €828 reduction in costs. The cost-effectiveness improved with a longer time horizon. A threshold of €30,000/QALY was passed after 18 months. The group training was cost saving after 33 months. CONCLUSIONS: Cognitive-behavioral group training is a cost-effective treatment compared with the wait-list control for patients with UPS.

Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study.

BACKGROUND: Chronic fatigue is present in more than 60% of the patients with a neuromuscular disease and can be their most disabling symptom. In combination with other impairments, fatigue often results in low levels of physical activity and decreased social participation, leading to high societal costs. 'Energetic' is a self-management group program aimed at improving social participation, physical endurance and alleviating fatigue in these patients. The primary aim of this study is to evaluate the effectiveness and cost-effectiveness of the Energetic program. METHODS/DESIGN: A multicentered, assessor-blinded, two-armed randomized controlled trial is conducted with evaluations at inclusion and four, seven and fifteen months later. The study includes patients with a neuromuscular disease and chronic fatigue and, when present, their caregivers. The participants are randomized (ratio 1:1) to either an intervention group, receiving the Energetic program, or a control group, receiving usual care (i.e., no specific intervention). The Energetic program covers four months and includes four modules: 1) individually tailored aerobic exercise training; 2) education about aerobic exercise; 3) self-management training in applying energy conservation strategies; and 4) implementation and relapse prevention in daily life. Two months after cessation of the program a booster session is provided. The primary outcome is the perceived performance score of the Canadian Occupational Performance Measure (COPM). Secondary outcomes include the COPM-satisfaction score, and measures of fatigue, physical endurance, activity engagement, mood, and self-efficacy. Caregiver burden is also evaluated as a secondary outcome. Health-related quality of life and medical and societal costs are assessed to estimate cost-effectiveness of the program. DISCUSSION: The Energetic study is the first randomized controlled trial to evaluate the effectiveness and cost-effectiveness of a combined physical and self-management group training program for improving social participation, physical endurance and alleviating fatigue in patients with neuromuscular diseases. It will generate new insights in (cost-)effective rehabilitation strategies for these incurable conditions. TRIAL REGISTRATION: Clinicaltrials.gov NCT02208687 .

HypoAware-a brief and partly web-based psycho-educational group intervention for adults with type 1 and insulin-treated type 2 diabetes and problematic hypoglycaemia: design of a cost-effectiveness randomised controlled trial.

BACKGROUND: Problematic hypoglycaemia is a significant problem among people with insulin-treated type 1 and 2 diabetes mellitus, which adversely affects quality of life and leads to high societal costs. Blood glucose awareness training (BGAT) is a psycho-educational group intervention that has shown to be effective but difficult to implement in clinical practice, due to its demanding nature. The aim of this study is to evaluate the cost-effectiveness of the HypoAware intervention that has its roots in BGAT and helps patients to effectively recognize, treat and prevent hypoglycaemia, while also focussing on the psychosocial consequences of living with the constant risk of hypoglycaemia, both for patients and their significant others. METHODS/DESIGN: An economic evaluation will be conducted alongside a cluster-randomised controlled trial in eight hospitals in the Netherlands. We aim to include 154 participants who will either receive HypoAware or care as usual. HypoAware consists of three group sessions and is combined with two online modules. The primary clinical outcome is severe hypoglycaemia. Secondary outcomes include mild hypoglycaemia, hypoglycaemia awareness, fear of hypoglycaemia, diabetes distress, anxiety and depression, health-related quality of life, diabetes-specific self-efficacy and HbA1c. Utilities will be measured using the EQ-5D-5 L questionnaire. Costs will be measured from a societal perspective and include health care utilization, medication and lost productivity costs. Measurements will be performed at baseline, 2, 4, and 6 months to compare both groups, and an additional 12 months for the intervention group only. Process outcomes will be gathered after every group meeting via telephone/email contact with health care professionals and via the online environment. DISCUSSION: HypoAware is expected to significantly reduce episodes of severe hypoglycaemia, with subsequent beneficial effects on psychosocial outcomes and health care costs. When proven cost-effective, HypoAware will be incorporated in the clinical guidelines of Dutch diabetes care. TRIAL REGISTRATION: Dutch Trial Register NTR4538.

The clinical and cost effectiveness of group art therapy for people with non-psychotic mental health disorders: a systematic review and cost-effectiveness analysis.

BACKGROUND: The majority of mental health problems are non-psychotic (e.g., depression, anxiety, and phobias). For some people, art therapy may be a more acceptable alternative form of psychological therapy than standard forms of treatment, such as talking therapies. This study was part of a health technology assessment commissioned by the National Institute for Health Research, UK and aimed to systematically appraise the clinical and cost-effective evidence for art therapy for people with non-psychotic mental health disorders. METHODS: Comprehensive literature searches for studies examining art therapy in populations with non-psychotic mental health disorders were performed in May 2013. A quantitative systematic review of clinical effectiveness and a systematic review of studies evaluating the cost-effectiveness of group art therapy were conducted. RESULTS: Eleven randomised controlled trials were included (533 patients). Meta-analysis was not possible due to clinical heterogeneity and insufficient comparable data on outcome measures across studies. The control groups varied between studies but included: no treatment/wait-list, attention placebo controls and psychological therapy comparators. Art therapy was associated with significant positive changes relative to the control group in mental health symptoms in 7 of the 11 studies. A de novo model was constructed and populated with data identified from the clinical review. Scenario analyses were conducted allowing comparisons of group art therapy with wait-list control and group art therapy with group verbal therapy. Group art-therapy appeared cost-effective compared with wait-list control with high certainty although generalisability to the target population was unclear; group verbal therapy appeared more cost-effective than art therapy but there was considerable uncertainty and a sizeable probability that art therapy was more cost effective. CONCLUSIONS: From the limited available evidence art therapy was associated with positive effects compared with control in a number of studies in patients with different clinical profiles. The included trials were generally of poor quality and are therefore likely to be at high risk of bias. Art therapy appeared to be cost-effective versus wait-list but further studies are needed to confirm this finding in the target population. There was insufficient evidence to make an informed comparison of the cost-effectiveness of group art therapy with group verbal therapy. TRIAL REGISTRATION: HTA project no. 12/27/16; PROSPERO registration no. CRD42013003957.

Life satisfaction, general well-being and costs of treatment for severe fear of childbirth in nulliparous women by psychoeducative group or conventional care attendance.

OBJECTIVE: Fear of childbirth is a common reason for seeking cesarean section. It is important to consider outcomes and costs associated with alternative treatment and delivery mode. We compared well-being and costs of group psychoeducation and conventional care for fear of childbirth. DESIGN: Randomized controlled trial. POPULATION: A total of 371 nulliparous women scoring over the 95th centile in the Wijma Delivery Expectancy Questionnaire (W-DEQ) during the first trimester. SETTING: Finland, data from obstetrical patient records and questionnaires. METHODS: Randomization to group psychoeducation with relaxation (six sessions during pregnancy, one after childbirth, n = 131), or surveillance and referral on demand (n = 240). MAIN OUTCOME MEASURES: All costs in maternity care during pregnancy, delivery and postnatally according to Diagnoses Related Groups. Life satisfaction and general well-being 3 months after childbirth (by a Satisfaction with Life Scale and Well-being Visual Analogue Scale). RESULTS: The groups did not differ in total direct costs (€3786/woman in psychoeducative group and €3830/woman in control group), nor in life satisfaction or general well-being. Although only 76 (30%) of the women assigned to the surveillance were referred to special maternity care and 36 (15%) attended advanced prenatal classes, costs in the psychoeducation group did not exceed the costs of the controls, mostly because of the greater number of uncomplicated vaginal deliveries (63% vs. 47%, p = 0.005). CONCLUSIONS: Through an association with safer childbirth and equal well-being after delivery, psychoeducative group treatment for nulliparous women with fear of childbirth can be a recommended choice for the same overall costs as conventional treatment.

Depression prevention, labour force participation and income of older working aged Australians: A microsimulation economic analysis.

OBJECTIVE: Depression has economic consequences not only for the health system, but also for individuals and society. This study aims to quantify the potential economic impact of five-yearly screening for sub-syndromal depression in general practice among Australians aged 45-64 years, followed by a group-based psychological intervention to prevent progression to depression. METHOD: We used an epidemiological simulation model to estimate reductions in prevalence of depression, and a microsimulation model, Health&WealthMOD2030, to estimate the impact on labour force participation, personal income, savings, taxation revenue and welfare expenditure. RESULTS: Group therapy is estimated to prevent around 5,200 prevalent cases of depression (2.2%) and add about 520 people to the labour force. Private incomes are projected to increase by $19 million per year, tax revenues by $2.4 million, and transfer payments are reduced by $2.6 million. CONCLUSION: Group-based psychological intervention to prevent depression could result in considerable economic benefits in addition to its clinical effects.

Effectiveness and cost-effectiveness of meaning-centered group psychotherapy in cancer survivors: protocol of a randomized controlled trial.

BACKGROUND: Meaning-focused coping may be at the core of adequate adjustment to life after cancer. Cancer survivors who experience their life as meaningful are better adjusted, have better quality of life and psychological functioning. Meaning-Centered Group Psychotherapy for Cancer Survivors (MCGP-CS) was designed to help patients to sustain or enhance a sense of meaning and purpose in their lives. The aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of MCGP-CS. METHODS/DESIGN: Survivors diagnosed with cancer in the last 5 years and treated with curative intent, are recruited via several hospitals in the Netherlands. After screening, 168 survivors are randomly assigned to one of the three study arms: 1. Meaning-Centered Group Psychotherapy (MCGP-CS) 2. Supportive group psychotherapy (SGP) 3. Care as usual (CAU). Baseline assessment takes place before randomisation, with follow up assessments post-intervention and at 3, 6 and 12 months follow-up. Primary outcome is meaning making (PMP, PTGI, SPWB). Secondary outcome measures address quality of life (EORTC-30), anxiety and depression (HADS), hopelessness (BHS), optimism (LOT-R), adjustment to cancer (MAC), and costs (TIC-P, EQ-5D, PRODISQ). DISCUSSION: Meaning-focused coping is key to adjustment to life after cancer, however, there is a lack of evidence based psychological interventions in this area. Many cancer survivors experience feelings of loneliness and alienation, and have a need for peer support, therefore a group method in particular, can be beneficial for sustaining or enhancing a sense of meaning. If this MCGP-CS is effective for cancer survivors, it can be implemented in the practice of psycho-oncology care. TRIAL REGISTRATION: Netherlands Trial Register, NTR3571.

Design of an international multicentre RCT on group schema therapy for borderline personality disorder.

BACKGROUND: Borderline personality disorder (BPD) is a severe and highly prevalent mental disorder. Schema therapy (ST) has been found effective in the treatment of BPD and is commonly delivered through an individual format. A group format (group schema therapy, GST) has also been developed. GST has been found to speed up and amplify the treatment effects found for individual ST. Delivery in a group format may lead to improved cost-effectiveness. An important question is how GST compares to treatment as usual (TAU) and what format for delivery of schema therapy (format A; intensive group therapy only, or format B; a combination of group and individual therapy) produces the best outcomes. METHODS/DESIGN: An international, multicentre randomized controlled trial (RCT) will be conducted with a minimum of fourteen participating centres. Each centre will recruit multiple cohorts of at least sixteen patients. GST formats as well as the orders in which they are delivered to successive cohorts will be balanced. Within countries that contribute an uneven number of sites, the orders of GST formats will be balanced within a difference of one. The RCT is designed to include a minimum of 448 patients with BPD. The primary clinical outcome measure will be BPD severity. Secondary clinical outcome measures will include measures of BPD and general psychiatric symptoms, schemas and schema modes, social functioning and quality of life. Furthermore, an economic evaluation that consists of cost-effectiveness and cost-utility analyses will be performed using a societal perspective. Lastly, additional investigations will be carried out that include an assessment of the integrity of GST, a qualitative study on patients' and therapists' experiences with GST, and studies on variables that might influence the effectiveness of GST. DISCUSSION: This trial will compare GST to TAU for patients with BPD as well as two different formats for the delivery of GST. By combining an evaluation of clinical effectiveness, an economic evaluation and additional investigations, it will contribute to an evidence-based understanding of which treatment should be offered to patients with BPD from clinical, economic, and stakeholders' perspectives. TRIAL REGISTRATION: Netherlands Trial Register NTR2392. Registered 25 June 2010.

Effect on arm function and cost of robot-assisted group therapy in subacute patients with stroke and a moderately to severely affected arm: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness and efficiency of robot-assisted arm group therapy (RAGT) versus individual arm therapy (IAT) to restore motor function in the moderately to severely affected patient after stroke. DESIGN: Single blind randomized controlled trial. SETTING: Two in-patient neurological rehabilitation centers. PARTICIPANTS: Fifty first time subacute patients with stroke and a non-functional hand. INTERVENTION: The patients practiced either 30 minutes of RAGT + 30 minutes of IAT (group A) or 2x30 minutes of IAT (group B), per workday for four weeks. The RAGT consisted of six workstations enabling repetitive practice of finger, wrist, forearm and shoulder movements. Patients practiced according to their impairment level on at least two workstations per session. The IAT followed the Motor Relearning Programme, enriched by elements of the impairment-oriented training. MAIN OUTCOME MEASURE: Changes of the Fugl Meyer Score (FM, 0-66) between baseline and after 4 weeks, incremental cost effectiveness. RESULTS: Patients were homogeneous at study onset. All patients improved their upper limb motor function over time, but there were no between group differences. The initial (terminal) FM scores were 14.6±9.4 (25.7±16.5) in group A and 16.5±9.8 (31.1±19.1) in group B. The treatment of a single patient with RAGT cost 4.15 €, compared to 10.00 € for a patient to receive IAT. CONCLUSION: RAGT in combination with IAT was equally effective as a double session of IAT regarding the restoration of upper limb motor functions in moderate to severely affected subacute patients with stroke. The treatment costs for RAGT were less.

[Ambulatory alcohol withdrawal]. / Der ambulante qualifizierte Alkoholentzug.

Alcohol addiction is a common problem in daily life as well as in medicine. Apart from inpatient therapy programs, ambulatory withdrawal is a relatively new option, which may be done safely, efficient and cost-effective close to the domicile an without stigmatisation of the patient.

Cost-effectiveness and cost-utility study of a psychoeducational group intervention for people with depression and physical comorbidity in primary care.

OBJECTIVE: To evaluate the cost-effectiveness and cost-utility of a psychoeducational group intervention led by primary care (PC) nurses in relation to customary care to prevent the depression and improve quality of life in patients with physical comorbidity. DESIGN: Economic evaluation based on data from randomized, multicenter clinical trial with blind response variables and a one-year follow-up, carried in the context of the PSICODEP study. LOCATION: 7 PC teams from Catalonia. PARTICIPANTS: >50 year-old patients with depression and some physical comorbidity: diabetes mellitus type 2, ischemic heart disease, chronic obstructive pulmonary disease, and/or asthma. INTERVENTION: 12 psychoeducational group sessions, 1 per week, led by 2 PC nurses with prior training. MEASUREMENTS: Effectiveness: depression-free days (DFD) calculated from the BDI-II and quality-adjusted life years (QALYs) from the Euroqol-5D. Direct costs: PC visits, mental health, emergencies and hospitalizations, drugs. Indirect costs: days of temporary disability (TD). The incremental cost-effectiveness ratios (ICER), cost-effectiveness (ΔCost/ΔDLD) and cost-utility (ΔCost/ΔQALY) were estimated. RESULTS: The study includes 380 patients (intervention group [IG] = 204; control group [CG] = 176). 81.6% women; mean age 68.4 (SD = 8.8). The IG had a higher mean cost of visits, less of hospitalizations and less TD than the CG. The difference in costs between the IG and the CG was -357.95€ (95% CI: -2026.96 to 1311.06) at one year of follow-up. There was a mean of 11.95 (95% CI: -15.98 to 39.88) more DFD in the IG than in the CG. QALYs were similar (difference -0.01, 95% CI -0.04 to 0.05). The ICERs were 29.95€/DLD and 35,795€/QALY. CONCLUSIONS: Psychoeducational intervention is associated with an improvement in DFD, as well as a reduction in costs at 12 months, although not significantly. QALYs were very similar between groups.

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

BACKGROUND: Fatigue is a common and troubling symptom for people with multiple sclerosis (MS). AIM: To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)). METHODS: Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire). RESULTS: Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue. CONCLUSIONS: FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76517470.

Group-based cognitive-behavioural anger management for people with mild to moderate intellectual disabilities: cluster randomised controlled trial.

BACKGROUND: Many people with intellectual disabilities find it hard to control their anger and this often leads to aggression which can have serious consequences, such as exclusion from mainstream services and the need for potentially more expensive emergency placements. AIMS: To evaluate the effectiveness of a cognitive-behavioural therapy (CBT) intervention for anger management in people with intellectual disabilities. METHOD: A cluster-randomised trial of group-based 12-week CBT, which took place in day services for people with intellectual disabilities and was delivered by care staff using a treatment manual. Participants were 179 service users identified as having problems with anger control randomly assigned to either anger management or treatment as usual. Assessments were conducted before the intervention, and at 16 weeks and 10 months after randomisation (trial registration: ISRCTN37509773). RESULTS: The intervention had only a small, and non-significant, effect on participants' reports of anger on the Provocation Index, the primary outcome measure (mean difference 2.8, 95% CI -1.7 to 7.4 at 10 months). However, keyworker Provocation Index ratings were significantly lower in both follow-up assessments, as were service-user ratings on another self-report anger measure based on personally salient triggers. Both service users and their keyworkers reported greater usage of anger coping skills at both follow-up assessments and keyworkers and home carers reported lower levels of challenging behaviour. CONCLUSIONS: The intervention was effective in improving anger control by people with intellectual disabilities. It provides evidence of the effectiveness of a CBT intervention for this client group and demonstrates that the staff who work with them can be trained and supervised to deliver such an intervention with reasonable fidelity.

Cost-effectiveness of an adjustment group for people with multiple sclerosis and low mood: a randomized trial.

OBJECTIVE: To evaluate the cost effectiveness of a psychological adjustment group shown to be clinically effective in comparison with usual care for people with multiple sclerosis. DESIGN: Randomized controlled trial with comparison of costs and calculation of incremental cost effectiveness ratio. SETTING: Community. PARTICIPANTS: People with multiple sclerosis were screened on the General Health Questionnaire 12 and Hospital Anxiety and Depression Scale, and those with low mood were recruited. INTERVENTIONS: Participants randomly allocated to the adjustment group received six group treatment sessions. The control group received usual care, which did not include psychological interventions. MAIN MEASURES: Outcomes were assessed four and eight months after randomization, blind to group allocation. The costs were assessed from a service use questionnaire and information provided on medication. Quality of life was assessed using the EQ-5D. RESULTS: Of the 311 patients identified, 221 (71%) met the criteria for having low mood. Of these, 72 were randomly allocated to receive treatment and 79 to usual care. Over eight months follow-up there was a decrease in the combined average costs of £378 per intervention respondent and an increase in the costs of £297 per patient in the control group, which was a significant difference (p=0.03). The incremental cost-effectiveness ratio indicated that the cost per point reduction on the Beck depression inventory-II was £118. CONCLUSION: In the short term, the adjustment group programme was cost effective when compared with usual care, for people with multiple sclerosis presenting with low mood. The longer-term costs need to be assessed.

Efficacy and intensity of day hospital treatment for eating disorders.

The purpose of the study was to compare the effectiveness of 4-day versus 5-day day hospital (DH) treatment and to document effectiveness based on a large sample size. Participants were 801 patients, diagnosed with an eating disorder, who participated in DH treatment from 1985 to 2009. The study followed a sequential cohort ABA design. Higher intensity DH was associated with higher rates of abstinence from bingeing and vomiting and larger improvements in depression and body dissatisfaction. Higher intensity DH provided no consistent advantage in rates of weight restoration or improvement on other indices of psychological functioning. These findings suggest that the optimal intensity of treatment may vary depending on treatment goals, but 5-day DH is recommended for eating disorders.