Cost-effectiveness of therapist-assisted internet-delivered psychological therapies for PTSD differing in trauma focus in England: an economic evaluation based on the STOP-PTSD trial.

BACKGROUND: Although there are effective psychological treatments for post-traumatic stress disorder (PTSD), they remain inaccessible for many people. Digitally enabled therapy is a way to overcome this problem; however, there is little evidence on which forms of these therapies are most cost effective in PTSD. We aimed to assess the cost-effectiveness of the STOP-PTSD trial, which evaluated two therapist-assisted, internet-delivered cognitive behavioural therapies: cognitive therapy for PTSD (iCT-PTSD) and a programme focusing on stress management (iStress-PTSD). METHODS: In this health economic evaluation, we used data from the STOP-PTSD trial (n=217), a single-blind, randomised controlled trial, to compare iCT-PTSD and iStress-PTSD in terms of resource use and health outcomes. In the trial, participants (aged ≥18 years) who met DSM-5 criteria for PTSD were recruited from primary care therapy services in South East England. The interventions were delivered online with therapist support for the first 12 weeks, and three telephone calls over the next 3 months. Participants completed questionnaires on symptoms, wellbeing, quality of life, and resource use at baseline, 13 weeks, 26 weeks, and 39 weeks after randomisation. We used a cost-effectiveness analysis to assess cost per quality-adjusted life year (QALY) at 39 weeks post-randomisation, from the perspective of the English National Health Service (NHS) and personal social services and on the basis of intention-to-treat for complete cases. Treatment modules and the platform design were developed with extensive input from service users: service users also advised on the trial protocol and methods, including the health economic measures. This is a pre-planned analysis of the STOP-PTSD trial; the trial was registered prospectively on the ISRCTN Registry (ISRCTN16806208). FINDINGS: NHS costs were similar across treatment groups, but clinical outcomes were superior for iCT-PTSD compared with iStress-PTSD. The incremental cost-effectiveness ratio for NHS costs and personal social services was estimated as £1921 per QALY. iCT-PTSD had an estimated 91·6% chance of being cost effective at the £20 000 per QALY threshold. From the societal perspective, iCT-PTSD was cost saving compared with iStress-PTSD. INTERPRETATION: iCT-PTSD is a cost-effective form of therapist-assisted, internet-delivered psychological therapy relative to iStress-PTSD, and it could be considered for clinical implementation. FUNDING: Wellcome Trust and National Institute of Health Research Oxford Health Biomedical Research Centre.

Therapist-assisted online psychological therapies differing in trauma focus for post-traumatic stress disorder (STOP-PTSD): a UK-based, single-blind, randomised controlled trial.

BACKGROUND: Many patients are currently unable to access psychological treatments for post-traumatic stress disorder (PTSD), and it is unclear which types of therapist-assisted internet-based treatments work best. We aimed to investigate whether a novel internet-delivered cognitive therapy for PTSD (iCT-PTSD), which implements all procedures of a first-line, trauma-focused intervention recommended by the UK National Institute for Health and Care Excellence (NICE) for PTSD, is superior to internet-delivered stress management therapy for PTSD (iStress-PTSD), a comprehensive cognitive behavioural treatment programme focusing on a wide range of coping skills. METHODS: We did a single-blind, randomised controlled trial in three locations in the UK. Participants (≥18 years) were recruited from UK National Health Service (NHS) Improving Access to Psychological Therapies (IAPT) services or by self-referral and met DSM-5 criteria for PTSD to single or multiple events. Participants were randomly allocated by a computer programme (3:3:1) to iCT-PTSD, iStress-PTSD, or a 3-month waiting list with usual NHS care, after which patients who still met PTSD criteria were randomly allocated (1:1) to iCT-PTSD or iStress-PTSD. Randomisation was stratified by location, duration of PTSD (<18 months or ≥18 months), and severity of PTSD symptoms (high vs low). iCT-PTSD and iStress-PTSD were delivered online with therapist support by messages and short weekly phone calls over the first 12 weeks (weekly treatment phase), and three phone calls over the next 3 months (booster phase). The primary outcome was the severity of PTSD symptoms at 13 weeks after random assignment, measured by self-report on the PTSD Checklist for DSM-5 (PCL-5), and analysed by intention-to-treat. Safety was assessed in all participants who started treatment. Process analyses investigated acceptability and compliance with treatment, and candidate moderators and mediators of outcome. The trial was prospectively registered with the ISRCTN registry, ISRCTN16806208. FINDINGS: Of the 217 participants, 158 (73%) self-reported as female, 57 (26%) as male, and two (1%) as other; 170 (78%) were White British, 20 (9%) were other White, six (3%) were Asian, ten (5%) were Black, eight (4%) had a mixed ethnic background, and three (1%) had other ethnic backgrounds. Mean age was 36·36 years (SD 12·11; range 18-71 years). 52 (24%) participants met self-reported criteria for ICD-11 complex PTSD. Fewer than 10% of participants dropped out of each treatment group. iCT-PTSD was superior to iStress-PTSD in reducing PTSD symptoms, showing an adjusted difference on the PCL-5 of -4·92 (95% CI -8·92 to -0·92; p=0·016; standardised effect size d=0·38 [0·07 to 0·69]) for immediate allocations and -5·82 (-9·59 to -2·04; p=0·0027; d=0·44 [0·15 to 0·72]) for all treatment allocations. Both treatments were superior to the waiting list for PCL-5 at 13 weeks (d=1·67 [1·23 to 2·10] for iCT-PTSD and 1·29 [0·85 to 1·72] for iStress-PTSD). The advantages in outcome for iCT-PTSD were greater for participants with high dissociation or complex PTSD symptoms, and mediation analyses showed both treatments worked by changing negative meanings of the trauma, unhelpful coping, and flashback memories. No serious adverse events were reported. INTERPRETATION: Trauma-focused iCT-PTSD is effective and acceptable to patients with PTSD, and superior to a non-trauma-focused cognitive behavioural stress management therapy, suggesting that iCT-PTSD is an effective way of delivering the contents of CT-PTSD, one of the NICE-recommended first-line treatments for PTSD, while reducing therapist time compared with face-to-face therapy. FUNDING: Wellcome Trust, UK National Institute for Health and Care Research Oxford Health Biomedical Research Centre.

What do others think? The why, when and how of using surveys in CBT.

Surveys are a powerful technique in cognitive behavioural therapy (CBT). A form of behavioural experiment, surveys can be used to test beliefs, normalise symptoms and experiences, and generate compassionate perspectives. In this article, we discuss why and when to use surveys in CBT interventions for a range of psychological disorders. We also present a step-by-step guide to collaboratively designing surveys with patients, selecting the appropriate recipients, sending out surveys, discussing responses and using key learning as a part of therapy. In doing so, we hope to demonstrate that surveys are a flexible, impactful, time-efficient, individualised technique which can be readily and effectively integrated into CBT interventions.

Ten misconceptions about trauma-focused CBT for PTSD.

Therapist cognitions about trauma-focused psychological therapies can affect our implementation of evidence-based therapies for posttraumatic stress disorder (PTSD), potentially reducing their effectiveness. Based on observations gleaned from teaching and supervising one of these treatments, cognitive therapy for PTSD (CT-PTSD), ten common 'misconceptions' were identified. These included misconceptions about the suitability of the treatment for some types of trauma and/or emotions, the need for stabilisation prior to memory work, the danger of 'retraumatising' patients with memory-focused work, the risks of using memory-focused techniques with patients who dissociate, the remote use of trauma-focused techniques, and the perception of trauma-focused CBT as inflexible. In this article, these misconceptions are analysed in light of existing evidence and guidance is provided on using trauma-focused CT-PTSD with a broad range of presentations.

'I'm unlikeable, boring, weird, foolish, inferior, inadequate': how to address the persistent negative self-evaluations that are central to social anxiety disorder with cognitive therapy.

Patients with social anxiety disorder (SAD) have a range of negative thoughts and beliefs about how they think they come across to others. These include specific fears about doing or saying something that will be judged negatively (e.g. 'I'll babble', 'I'll have nothing to say', 'I'll blush', 'I'll sweat', 'I'll shake', etc.) and more persistent negative self-evaluative beliefs such as 'I am unlikeable', 'I am foolish', 'I am inadequate', 'I am inferior', 'I am weird/different' and 'I am boring'. Some therapists may take the presence of such persistent negative self-evaluations as being a separate problem of 'low self-esteem', rather than seeing them as a core feature of SAD. This may lead to a delay in addressing the persistent negative self-evaluations until the last stages of treatment, as might be typically done in cognitive therapy for depression. It might also prompt therapist drift from the core interventions of NICE recommended cognitive therapy for social anxiety disorder (CT-SAD). Therapists may be tempted to devote considerable time to interventions for 'low self-esteem'. Our experience from almost 30 years of treating SAD within the framework of the Clark and Wells (1995) model is that when these digressions are at the cost of core CT-SAD techniques, they have limited value. This article clarifies the role of persistent negative self-evaluations in SAD and shows how these beliefs can be more helpfully addressed from the start, and throughout the course of CT-SAD, using a range of experiential techniques. Key learning aims: To recognise persistent negative self-evaluations as a key feature of SAD.To understand that persistent negative self-evaluations are central in the Clark and Wells (1995) cognitive model and how to formulate these as part of SAD.To be able to use all the experiential interventions in cognitive therapy for SAD to address these beliefs.

Treating posttraumatic stress disorder remotely with cognitive therapy for PTSD.

Delivering trauma-focused cognitive behavioural therapy to patients with PTSD during the COVID-19 pandemic poses challenges. The therapist cannot meet with the patient in person to guide them through trauma-focused work and other treatment components, and patients are restricted in carrying out treatment-related activities and behavioural experiments that involve contact with other people. Whilst online trauma-focused CBT treatments for PTSD have been developed, which overcome some of these barriers in that they can be delivered remotely, they are not yet routinely available in clinical services in countries, such as the UK. Cognitive therapy for PTSD (CT-PTSD) is a trauma-focused cognitive behavioural therapy that is acceptable to patients, leads to high rates of recovery and is recommended as a first-line treatment for the disorder by international clinical practice guidelines. Here we describe how to deliver CT-PTSD remotely so that patients presenting with PTSD during the COVID-19 pandemic can still benefit from this evidence-based treatment.

Brindar terapia cognitivo conductual (TCC) centrada en el trauma a pacientes con Trastorno de Estrés Postraumático (TEPT) durante la pandemia de COVID-19 plantea desafíos. El terapeuta no puede reunirse con el paciente en persona para guiarlo a través del trabajo centrado en el trauma y apoyarlo con otros componentes del tratamiento; y por otra parte, los pacientes tienen restricciones para llevar a cabo las actividades relacionadas con el tratamiento y los experimentos de comportamiento que impliquen contacto con otras personas. Si bien se han desarrollado tratamientos de TCC centrados en el trauma en línea para el TEPT, que superan algunas de estas barreras en el sentido de que pueden administrarse de forma remota, todavía no están disponibles de forma rutinaria en los servicios clínicos de los países, como en el Reino Unido. La terapia cognitiva para el TEPT (TC-TEPT) es una terapia cognitiva conductual centrada en el trauma que es aceptable para los pacientes, conduce a altas tasas de recuperación y se recomienda como tratamiento de primera línea para el trastorno según las pautas internacionales de práctica clínica (APA, 2017; International Society of Traumatic Stress Studies, 2019; National Institute of Health and Clinical Excellence, 2018). Aquí describimos cómo administrar TC-TEPT de forma remota para que los pacientes que se presentan con TEPT durante la pandemia de COVID-19 aún puedan beneficiarse de este tratamiento basado en la evidencia.

A randomised controlled trial of therapist-assisted online psychological therapies for posttraumatic stress disorder (STOP-PTSD): trial protocol.

BACKGROUND: Over the last few decades, effective psychological treatments for posttraumatic stress disorder (PTSD) have been developed, but many patients are currently unable to access these treatments. There is initial evidence that therapist-assisted internet-based psychological treatments are effective for PTSD and may help increase access, but it remains unclear which of these treatments work best and are most acceptable to patients. This randomised controlled trial will compare a trauma-focussed and a nontrauma-focussed therapist-assisted cognitive behavioural Internet treatment for PTSD: Internet-delivered cognitive therapy for PTSD (iCT-PTSD) and internet-delivered stress management therapy (iStress-PTSD). METHODS/DESIGN: The study is a single-blind, randomised controlled trial comparing iCT-PTSD, iStress-PTSD and a 13-week wait-list condition, with an embedded process study. Assessors of treatment outcome will be blinded to trial arm. Two hundred and seventeen participants who meet DSM-5 criteria for PTSD will be randomly allocated by a computer programme to iCT-PTSD, iStress-PTSD or wait-list at a 3:3:1 ratio. The primary assessment point is at 13 weeks, and further assessments are taken at 6, 26, 39 and 65 weeks. The primary outcome measure is the severity of PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary measures of PTSD symptoms are the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the Impact of Event Scale-Revised (IES-R). Other symptoms and well-being will be assessed with the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder Scale (GAD-7), WHO (Five) Well-Being Index, Work and Social Adjustment Scale (WSAS), Endicott Quality of Life Scale (QoL), and Insomnia Sleep Index (ISI). Health economics analyses will consider quality of life, productivity, health resource utilisation, employment status and state benefits, and treatment delivery costs. Process analyses will investigate candidate mediators and moderators of outcome. Patient experience will be assessed by interview and questionnaire. DISCUSSION: This study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed therapist-assisted online cognitive behavioural treatment for people with posttraumatic stress disorder. TRIAL REGISTRATION: ISRCTN16806208. Registered prospectively on 5 January 2018.

Cognitive therapy for post-traumatic stress disorder following critical illness and intensive care unit admission.

Around a quarter of patients treated in intensive care units (ICUs) will develop symptoms of post-traumatic stress disorder (PTSD). Given the dramatic increase in ICU admissions during the COVID-19 pandemic, clinicians are likely to see a rise in post-ICU PTSD cases in the coming months. Post-ICU PTSD can present various challenges to clinicians, and no clinical guidelines have been published for delivering trauma-focused cognitive behavioural therapy with this population. In this article, we describe how to use cognitive therapy for PTSD (CT-PTSD), a first line treatment for PTSD recommended by the National Institute for Health and Care Excellence. Using clinical case examples, we outline the key techniques involved in CT-PTSD, and describe their application to treating patients with PTSD following ICU. KEY LEARNING AIMS: To recognise PTSD following admissions to intensive care units (ICUs).To understand how the ICU experience can lead to PTSD development.To understand how Ehlers and Clark's (2000) cognitive model of PTSD can be applied to post-ICU PTSD.To be able to apply cognitive therapy for PTSD to patients with post-ICU PTSD.

Treating social anxiety disorder remotely with cognitive therapy.

Remote delivery of evidence-based psychological therapies via video conference has become particularly relevant following the COVID-19 pandemic, and is likely to be an on-going method of treatment delivery post-COVID. Remotely delivered therapy could be of particular benefit for people with social anxiety disorder (SAD), who tend to avoid or delay seeking face-to-face therapy, often due to anxiety about travelling to appointments and meeting mental health professionals in person. Individual cognitive therapy for SAD (CT-SAD), based on the Clark and Wells (1995) model, is a highly effective treatment that is recommended as a first-line intervention in NICE guidance (NICE, 2013). All of the key features of face-to-face CT-SAD (including video feedback, attention training, behavioural experiments and memory-focused techniques) can be adapted for remote delivery. In this paper, we provide guidance for clinicians on how to deliver CT-SAD remotely, and suggest novel ways for therapists and patients to overcome the challenges of carrying out a range of behavioural experiments during remote treatment delivery. KEY LEARNING AIMS: To learn how to deliver all of the core interventions of CT-SAD remotely.To learn novel ways of carrying out behavioural experiments remotely when some in-person social situations might not be possible.

Effect of fitness on incident diabetes from statin use in primary prevention.

OBJECTIVE: To assess the effect of cardiorespiratory fitness on the association between the initiation of statin therapy and incident diabetes. PATIENTS AND METHODS: In a prospective observational study, we studied 6519 generally healthy men and 2334 women with two preventive health examinations from December 15, 1998 through December 18, 2013 which included measurement of fitness levels, statin therapy, risk factors for diabetes, and incident diabetes. RESULTS: 93 cases of incident diabetes occurred during an average follow-up of 3.0 years. After multivariable adjustment, an increased odds of incident diabetes with statin use was observed in those patients with impaired fasting glucose at baseline (odds ratio [OR]: 2.15, [95% CI:1.26 to 3.67]), but not among individuals with normal glucose levels (OR:1.85, [95% CI: 0.76 to 4.52]). Cardiorespiratory fitness attenuated but did not eliminate the increased risk of incident diabetes with statin use. CONCLUSION: In a population of relatively healthy patients, statin use was not associated with incident diabetes in patients with normal fasting glucose at baseline. However, it was associated with incident diabetes in those patients with impaired fasting glucose at baseline, though this risk was substantially reduced by increasing fitness. In addition, increasing cardiorespiratory fitness was inversely associated with incident diabetes whether or not a patient was treated with a statin.