Cost Effectiveness of Internet-Delivered Acceptance and Commitment Therapy for Patients with Severe Health Anxiety: A Randomised Controlled Trial.

BACKGROUND: Health anxiety is a prevalent and debilitating disorder associated with extensive use of healthcare services and reduced quality of life (QoL). Regional variability in specialised clinics or specialist healthcare providers limits access to evidence-based treatment, which may be overcome by internet-delivered Acceptance and Commitment Therapy (iACT). OBJECTIVE: This study investigated the cost effectiveness of iACT for severe health anxiety in adults. METHODS: Based on a Danish randomised controlled trial (March 2016-March 2017), the economic evaluation compared costs and effects between iACT and an active control condition (iFORUM). Effectiveness was measured using self-report questionnaires. The cost analysis applied a societal perspective. Resource use and healthcare costs were extracted from the Danish National Registries. Linear regression analysis was applied using change in costs/effectiveness outcomes as the dependant variable. Time, group, and interaction between time and group were independent variables. The primary outcome was the proportion of clinically significant improvements, defined as a ≥ 25% reduction in two measures of health anxiety. The probability of cost effectiveness was presented in a cost-effectiveness acceptability curve for a range of threshold values for willingness to pay. RESULTS: No significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes. The economic analysis showed that, from the healthcare perspective, iACT was associated with an incremental cost-effectiveness ratio of €33 per additional case of clinically significant improvement compared with iFORUM and that, from the societal perspective, iACT dominated iFORUM because it was more effective and less expensive. CONCLUSIONS: We found no statistically significant differences in costs between groups; however, iACT for severe health anxiety may be cost effective, as evidenced by significant differences in effect. TRIAL REGISTRY NUMBER: Clinicaltrials.gov, no. NCT02735434.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

Efficacy of internet-delivered acceptance and commitment therapy for severe health anxiety: results from a randomized, controlled trial.

BACKGROUND: Health anxiety is common, disabling and costly due to patients' extensive use of health care services. Internet-delivered treatment may overcome barriers of accessibility to specialized treatment. We aimed to evaluate the efficacy of internet-delivered acceptance and commitment therapy (iACT). METHODS: A randomized, controlled trial of iACT versus an internet-delivered discussion forum (iFORUM), performed in a Danish university hospital setting. Patients self-referred and underwent video-diagnostic assessment. Eligible patients (≥18 years) with health anxiety were randomized to 12 weeks of intervention. The randomization was blinded for the assessor. The primary outcome was between-group unadjusted mean differences in health anxiety symptoms measured by the Whiteley-7 Index (WI-7, range 0-100) from baseline to 6-month follow-up (6-MFU) using intention to treat and a linear mixed model. The study is registered at clinicaltrials.gov, number NCT02735434. RESULTS: A total of 151 patients self-referred, and 101 patients were randomized to iACT (n = 53) or iFORUM (n = 48). A mean difference in change over time of 19.0 points [95% confidence interval (CI) 10.8-27.2, p < 0.001] was shown on the WI-7, and a large standardized effect size of d = 0.80 (95% CI 0.38-1.23) at 6-MFU. The number needed to treat was 2.8 (95% CI 1.8-6.1, p < 0.001), and twice as many patients in iACT were no longer clinical cases (35% v. 16%; risk ratio 2.17, 95% CI 1.00-4.70, p = 0.050). Adverse events were few and insignificant. CONCLUSIONS: iACT for health anxiety led to sustained effects at 6-MFU. The study contributes to the development of easily accessible treatment options and deserves wider application.

Study protocol: a randomized controlled trial comparing the efficacy of therapist guided internet-delivered cognitive therapy (TG-iConquerFear) with augmented treatment as usual in reducing fear of cancer recurrence in Danish colorectal cancer survivors.

BACKGROUND: Cognitive therapy has been shown to reduce fear of cancer recurrence (FCR), mainly in breast cancer survivors. The accessibility of cognitive behavioural interventions could be further improved by Internet delivery, but self-guided interventions have shown limited efficacy. The aim of this study is to test the efficacy of a therapist guided internet-delivered intervention (TG-iConquerFear) vs. augmented treatment as usual (aTAU) in Danish colorectal cancer survivors. METHODS/DESIGN: A population-based randomized controlled trial (RCT) comparing TG-iConquerFear with aTAU (1:1) in n = 246 colorectal cancer survivors who suffer from clinically significant FCR (Fear of Cancer Recurrence Inventory Short Form (FCRI-SF) ≥ 22 and semi-structured interview). Evaluation will be conducted at 2 weeks, 3 and 6 months post-treatment and between-group differences will be evaluated. Long-term effects will be evaluated after one year. Primary outcome will be post-treatment FCR (FCRI-SF). Secondary outcomes are global overall health and global quality of life (Visual Analogue Scales 0-100), bodily distress syndrome (BDS checklist), health anxiety (Whiteley-6), anxiety (SCL4-anx), depression (SCL6-dep) and sickness absence and health expenditure (register data). Explanatory outcomes include: Uncertainty in illness (Mishels uncertainty of illness scale, short form, MUIS), metacognitions (MCQ-30 negative beliefs about worry subscale), and perceived risk of cancer recurrence (Visual analogue Scale 1-100). DISCUSSION: This RCT will provide valuable information on the clinical and cost-effectiveness of TG-iConquerFear vs. aTAU for CRC survivors with clinical FCR, as well as explanatory variables that may act as outcome moderators or mediators. TRIAL REGISTRATION: ClinicalTrials.gov; NCT04287218, registered 25.02.2020. https://clinicaltrials.gov/ct2/results?cond=&term=NCT04287218&cntry=&state=&city=&dist=.

Using Illness Perceptions to Cluster Chronic Pain Patients: Results From a Trial on the Chronic Pain Self-Management Program.

OBJECTIVES: The aims of our study were (1) to identify possible subgroups of individuals with chronic pain based on their illness perceptions (IPs); (2) to examine whether these subgroups differed in health status and health expenditure; and (3) to examine whether the subgroups differed in their response to participation in a lay-led Chronic Pain Self-Management Program (CPSMP). MATERIALS AND METHODS: Four hundred twenty-four participants in a randomized controlled trial on the CPSMP completed a questionnaire on their perceptions of their chronic pain condition at baseline. In addition, they completed a range of health status measures at baseline and 3 months after end of participation in the CPSMP. Health care expenditure was obtained from Danish health registers. We performed cluster analyses to identify possible subgroups based on the participants' perceptions of their chronic pain condition. RESULTS: Cluster analysis of IPs resulted in 3 meaningful clusters, classified as "distressed, certain cause," "distressed, uncertain cause," and "nondistressed, certain cause," respectively. The 2 distressed groups had significantly higher scores on pain catastrophizing, illness worry, and emotional distress than did the nondistressed. Moderator analyses showed, that the "distressed, certain cause" had significant positive effect of participating in the CPSMP on pain catastrophizing and emotional distress, whereas the "distressed, uncertain cause" had a decrease and the "nondistressed, certain cause" an increase in primary health expenditure. DISCUSSION: Clusters based on IPs meaningfully distinguished individuals with chronic pain on health measures and outcome of participating in the CPSMP, and may prove useful in future studies to understand responses to treatment.

Neuroticism and maladaptive coping in patients with functional somatic syndromes.

OBJECTIVES: The cognitive-behavioural model of functional somatic syndromes (FSS) proposes a multifactorial aetiology consisting of predisposing, precipitating and perpetuating factors. In this study, we sought to investigate three questions that can be drawn from this model: (1) Do patients with FSS show high levels of neuroticism? (2) Does neuroticism affect physical health and social functioning, either directly or indirectly through maladaptive coping? (3) Does more adaptive coping mediate the effect of cognitive-behavioural therapy (CBT) on outcome? DESIGN: Secondary analysis of a randomized controlled trial (RCT) using additional data. METHOD: We used yet unpublished data on neuroticism (measured with Temperament and Character Inventory, Revised) and coping (measured with Coping Strategies Questionnaire) together with already reported outcomes (physical health and social functioning measured with SF-36) from an RCT comparing group CBT with enhanced usual care in 120 patients with a range of FSS. Neuroticism was measured at referral, while coping and outcomes were measured at referral, baseline, 4 and 16 months after randomization. Our hypotheses were explored through a series of cross-sectional (linear regression and structural equation models) and longitudinal (mediation) analyses. RESULTS: Patients with FSS showed higher levels of neuroticism than two healthy comparison groups. At referral, symptom catastrophizing partly mediated the negative association between neuroticism and outcome. Reduction in symptom catastrophizing during group CBT partially mediated its long-term effect. CONCLUSIONS: The results give support to a generic cognitive-behavioural model of FSS. Targeting symptom catastrophizing may be an essential component in CBT for patients with FSS, regardless of their specific diagnosis. Statement of contribution What is already known on this subject? Previous studies have found support for single components of the cognitive-behavioural model such as dysfunctional illness beliefs or avoidant coping. Most studies have investigated single functional somatic syndromes (FSS) such as fibromyalgia or irritable bowel syndrome. What does this study add? Predisposing neuroticism was linked to poor physical health through symptom catastrophizing across a range of FSS. Reduced symptom catastrophizing during group cognitive-behavioural therapy partially mediated its long-term effect. Addressing symptom catastrophizing may be a key element of the management of patients with FSS.

Long-term consequences of severe health anxiety on sick leave in treated and untreated patients: Analysis alongside a randomised controlled trial.

Health anxiety (HA) is prevalent and costly for health services. However, little is known about the full societal burden of HA. Based on complete register data, we (1) compared weeks on sickness-related benefits (SB) in untreated patients with severe HA (n=126) with a matched population sample (n=12,600); and (2) tested whether Acceptance & Commitment group Therapy (ACT-G) (n=63) reduced weeks on SB during the first year after randomisation compared to a waitlist (n=63). We found that (1) HA patients showed a six-monthly increment of 2 weeks on SB compared with the general population (p<0.0001), and (2) that ACT-G and the waitlist showed no difference in their ability to reduce SB during the first year (p=0.246). We conclude that HA is associated with a considerable societal burden. A possible beneficial effect of psychotherapy on SB needs further investigation.

Physical symptom attributions: a defining characteristic of somatoform disorders?

OBJECTIVES: We examined whether primary care patients were more likely to perceive a current health problem as 'physical illness only' as opposed to entailing psychological difficulties if they had a comorbid somatoform disorder compared to patients who had (a) both comorbid somatoform disorder and anxiety/depression or (b) comorbid anxiety and/or depression, and a reference group of (c) patients with well-defined physical disease. We examined whether attributions predicted future health expenditures. METHODS: A total of 1209 of 1785 patients completed questions on patient-perceived illness. The physicians diagnosed the current health problem. A stratified subsample was interviewed using the Schedules for Clinical Assessment in Neuropsychiatry. Health expenditure was obtained from registers for a 2-year period. RESULTS: The belief that the current health problem was only physical was endorsed by 86% of patients presenting physical disease, 58% of patients with somatoform disorders, 29% of patients with both somatoform disorders and anxiety/depression and 24% of patients with anxiety or depressive disorders (χ2=269.2, df=3, P<.0001). In a multiple regression model, a 'physical illness only' perception predicted lower health expenditures [ß = -0.31, 95% confidence interval (-0.55; -0.07), P=.013]. CONCLUSIONS: The prevalent assumption that physical symptom attributions are a central aspect in somatoform disorders is not supported by the current study.

Which is more important for outcome: the physician's or the patient's understanding of a health problem? A 2-year follow-up study in primary care.

OBJECTIVE: We sought to examine (1) whether the patients' and the family physicians' (FPs') beliefs about the nature of a health problem predict health outcomes and (2) whether the FPs were aware of their patients' beliefs. METHODS: A 2-year follow-up study of 38 FPs and 1131 patients presenting with well-defined physical disease (n=922) or medically unexplained symptoms (MUS) (n=209) according to the FPs was conducted. Before the consultation, patients categorized their health problem as being either physical or both physical and psychological. After the consultation, the FPs judged their patients' understanding of the health problem. Outcome measures were (1) patient satisfaction (seven-item Patient Satisfaction Consultation Questionnaire), (2) self-perceived mental and physical health (component summaries of the Medical Outcome Study's Short Form: SF-36) and (3) health care use extracted from patient registers. MAIN RESULTS: Patients with MUS according to the FPs and patients who believed that the nature of their health problem was both physical and psychological had higher health care use and worse self-rated health than patients in cases where both the FP and the patient had a physical understanding. Patients presenting MUS were more dissatisfied with the consultation than patients with well-defined physical disease. Overall, the FPs' perceptions of their patients' understanding were accurate in 82% of the consultations, but when the patients had a both physical and psychological understanding of their health problem, the FPs were right in only 26% of the consultations. CONCLUSIONS: Both FPs' diagnoses and patients' beliefs predict important health outcomes such as patient satisfaction, use of health care and self-rated health.