Understanding the psychological therapy treatment outcomes for young adults who are not in education, employment, or training (NEET), moderators of outcomes, and what might be done to improve them.

BACKGROUND: To determine: whether young adults (aged 18-24) not in education, employment or training (NEET) have different psychological treatment outcomes to other young adults; any socio-demographic or treatment-related moderators of differential outcomes; and whether service-level changes are associated with better outcomes for those who are NEET. METHODS: A cohort was formed of 20 293 young adults treated with psychological therapies in eight Improving Access to Psychological Therapies services. Pre-treatment characteristics, outcomes, and moderators of differential outcomes were compared for those who were and were not NEET. Associations between outcomes and the following were assessed for those that were NEET: missing fewer sessions, attending more sessions, having a recorded diagnosis, and waiting fewer days between referral and starting treatment. RESULTS: Those who were NEET had worse outcomes: odds ratio (OR) [95% confidence interval (CI)] for reliable recovery = 0.68 (0.63-0.74), for deterioration = 1.41 (1.25-1.60), and for attrition = 1.31 (1.19-1.43). Ethnic minority participants that were NEET had better outcomes than those that were White and NEET. Living in deprived areas was associated with worse outcomes. The intensity of treatment (high or low) did not moderate outcomes, but having more sessions was associated with improved outcomes for those that were NEET: odds (per one-session increase) of reliable recovery = 1.10 (1.08-1.12), deterioration = 0.94 (0.91-0.98), and attrition = 0.68 (0.66-0.71). CONCLUSIONS: Earlier treatment, supporting those that are NEET to attend sessions, and in particular, offering them more sessions before ending treatment might be effective in improving clinical outcomes. Additional support when working with White young adults that are NEET and those in more deprived areas may also be important.

Insomnia, depression, and anxiety symptoms interact and individually impact functioning: A network and relative importance analysis in the context of insomnia.

STUDY OBJECTIVES: Insomnia, depression, and anxiety show high rates of comorbidity and functional impairment. Transdiagnostic symptom interactions may be implicated in this comorbidity. This network analysis sought to assess how symptoms of insomnia, depression, and anxiety may interact and individually predict impairment across several domains for individuals with insomnia. METHODS: Baseline psychometric data from a randomised controlled trial were analysed (N = 1711). A regularized partial correlation network was estimated from the symptom data. Centrality (symptom connectivity), community structure (symptom clustering), and bridging (inter-community connectivity) were assessed. The replicability of the network model was assessed via confirmatory analyses in a holdout sample. Separately, Shapley values were estimated to determine the relative importance of each symptom in predicting functioning (i.e., psychological wellbeing, psychosocial functioning, and physical health impairment). RESULTS: The most connected nodes were uncontrollable worrying; trouble relaxing; and depressed mood/hopelessness. Five communities were identified with trouble relaxing identified as the bridge symptom between communities. The model showed good fit in the holdout sample. Low energy and depressive affect symptoms (feelings of failure/guilt; depressed mood/hopelessness; anhedonia) were key predictors in the relative importance analysis across multiple domains of impairment. CONCLUSION: Trouble relaxing may be of clinical and transdiagnostic significance in the context of insomnia. In terms of how symptoms relate to functioning, it was clear that, while low energy and feelings of failure/guilt were prominent predictors, a range of symptoms are associated with functional impairment. Consideration of both symptoms and functional impairment across domains may be useful in determining targets for treatment. CLINICAL TRIAL REGISTRATION: This is a secondary analysis of an original clinical trial. TRIAL REGISTRATION NUMBER: ISRCTN60530898. Registry URL: https://www.isrctn.com/ISRCTN60530898.

The cognitive-phenomenological assessment of delusions and hallucinations at the early intervention in psychosis service stage: The results of a quality improvement project.

AIM: Clinical assessments are vital for gaining an understanding of a patients' presenting problem. A priority for Early Intervention in Psychosis Service staff is understanding and supporting their patients' experiences of hallucinations and/or delusions. We aimed to identify what cognitive-phenomenology dimensions of hallucinations and delusions EIPS staff were assessing with their patients. METHODS: We developed a brief checklist of cognitive-phenomenological dimensions of hallucinations and delusions called the Lived Experience Symptom Survey (LESS) based on relevant literature. As part of a Quality Improvement Project, we reviewed the health records of a sub-sample of EIPS patients using the LESS identifying whether each dimension was present or absent. RESULTS: We found that all patients had been asked about the content of their hallucinations and/or delusions, and the majority had been asked about the valence of this content. Despite patients having experienced psychosis for almost 2 years on average, less than half of patients were asked about the potential or actual harm associated with these symptoms. All other cognitive-phenomenological dimensions were assessed inconsistently. CONCLUSIONS: The assessment of hallucination and delusions in our EIPS was inconsistent and incomprehensive. These findings require replication in other EIPS' but may point to a need for guidelines and training around how to conduct a thorough assessment of hallucinations and delusions for current and future EIPS staff. Improved assessment of these symptoms will aid the development of risk assessments and treatment plans.

Older adults respond better to psychological therapy than working-age adults: evidence from a large sample of mental health service attendees.

BACKGROUND: Older adults commonly experience depression and anxiety, yet are under-represented in psychological treatment services. There is uncertainty about the outcomes from psychological therapies for older adults relative to working-age adults. This study explored: pre-treatment differences between older and working-age patients with depression or anxiety disorders; whether outcomes from psychological therapy differ between groups controlling for pre-treatment clinical severity, functioning, and socio-demographics; and whether the impact of a long-term health condition (LTC) on outcome differs by age. METHODS: Data on >100,000 patients treated with psychological therapies in eight Improving Access to Psychological Therapies services were analyzed. We compared pre-treatment characteristics and therapy outcomes for older (≥65 years) and working-age (18-64 years) patients, and investigated associations between age and outcomes. RESULTS: Older adults had less severe clinical presentations pre-treatment. In adjusted models older adults were more likely to reliably recover (OR=1.33(95%CI=1.24-1.43)), reliably improve (OR=1.34(95%CI =1.24-1.45)), and attrition was less likely (OR=0.48(95%CI =0.43-0.53)). Effects were more pronounced in patients with anxiety disorders compared to depression. Having an LTC was associated with a much lower likelihood of reliable recovery for working-age patients but had only a modest effect for older adults. LIMITATIONS: There are potential selection biases affecting the characteristics of older people attending these services. Residual confounding cannot be ruled out due to limits on data available. CONCLUSIONS: Older adults experienced better outcomes from psychological treatments than working-age adults. Given the deleterious effects if mental health conditions go untreated, increasing access to psychological therapies for older people should be an international priority.

Training Curriculum, Skills, and Competencies for Global Health Leaders: Good Practices and Lessons Learned.

Objectives: This paper aims to depict unique perspectives and to compare and contrast three leadership programs for global health in order to enable other training institutions to design impactful curricula. Methods: We purposively selected three global health training programs. We used a six-step curriculum development framework to systematically compare the curriculum process across programs and to identify best practices and factors contributing to the impact of each of these programs. Findings: All three fellowship programs undertook an intentional and in-depth approach to curriculum development. Each identified competencies related to leadership and technical skills. Each defined goals, though the goals differed to align with the desired impact of the program, ranging from improving the impact of HIV programming, supporting stronger global health program implementation, and supporting the next generation of global health leaders. All programs implemented the curriculum through an onboarding phase, a delivery of core content in different formats, and a wrap-up or endline phase. During implementation, each program also utilized networking and mentoring to enhance connections and to support application of learning in work roles. Programs faced overlapping challenges and opportunities including funding, strengthening partnerships, and finding ways to engage and support alumni. Conclusions: Local ownership of programs is critical, including tailoring curricula to the needs of specific contexts. Strong partnerships and resources are needed to ensure program sustainability and impact. Key Takeaways: Global health competencies and curricula should be linked to local health system needs and contexts where learners are working.Emphasizing both individualistic and collectivist approaches to learning is important in engaging and supporting diverse global health learners.Emphasizing mentorship and opportunities to apply learning in contexts where learners are working is important in order to provide support to learners as they work to integrate what they are learning into their professional roles and activities.Partnerships and resources-including donor support-are essential to implement and sustain robust leadership curricula and to provide opportunities for experiential and didactic learning.

Trends in depression & anxiety symptom severity among mental health service attendees during the COVID-19 pandemic.

BACKGROUND: General population surveys have shown that some groups, particularly young women, experienced increased distress during nationally mandated restrictions to control the spread of COVID-19. However, there has been limited research on such trends among people with pre-existing mental health conditions, leaving mental health services ill equipped to plan for current and future lockdowns. METHODS: Mean weekly scores on the GAD-7 and PHQ-9 between 01/01/2020-22/06/2020 (n=9,538 individuals) for all patients of two psychological treatment services (Improving Access to Psychological Therapies) in London, were compared to mean weekly scores from the same time periods in 2017-2019 (n=37,849). The proportion of scores which were above the clinical thresholds for 'caseness' each week were compared, and scores between groups based on gender, age group, and ethnicity, were also compared. RESULTS: Confirmed community transmission in the UK (26/02/2020-03/03/2020) and the announcement of the national 'lockdown' (23/03/2020) were associated with significant increases in anxiety symptom scores. 'Lockdown' was associated with a decrease in depression scores. These changes were not maintained during lockdown. Significant increases in depression and anxiety were observed at week 23, as restrictions were eased. LIMITATIONS: This was an exploratory analysis in two services only. Residual confounding and selection biases cannot be ruled out. CONCLUSIONS: Differences in the weekly average symptom scores were short-term; they did not continue throughout 'lockdown' as might have been expected, except among older people. Replication of this study in other settings and investigating the potential benefits of more regular reviews or more intensive treatments for at-risk groups, are warranted.

Improvement in IAPT outcomes over time: are they driven by changes in clinical practice?

Treatment outcomes across Improving Access to Psychological Therapies (IAPT) services in England have improved year-on-year, with the national average proportion of patients in recovery at the end of treatment now exceeding the 50% target. This is despite the number of referrals and numbers of treated patients also increasing year-on-year, suggesting that services have evolved local practices and treatment delivery to meet needs whilst improving performance. This study explores whether there have been changes in clinical practice with regard to: (1) the number of sessions and length of treatments; (2) the number of cancellations and non-attendance; and (3) the recording of problem descriptor information, and the association with treatment outcomes in IAPT. Routinely collected data from seven IAPT services involved in the North and Central East London (NCEL) IAPT Service Improvement and Research Network (SIRN) were brought together to form a dataset of nearly 88,000 patients who completed a course of IAPT treatment. Results showed that there was a slight increase in the average number of sessions, and decreases in the length of time in treatment, as well as decreases in both the number of non-attended appointments and the use of inappropriate problem descriptors. These findings highlight a number of areas where potentially small changes to clinical practice may have had positive effects on patient outcomes. The value of using IAPT data to inform service improvement evaluations is discussed. KEY LEARNING AIMS: (1)How changes to treatment-delivery factors are associated with IAPT patient outcomes.(2)The link between clinical practice and potential service performance.(3)How analysing routinely collected data can be used to inform service improvement.

Dynamic interpersonal therapy for moderate to severe depression: a pilot randomized controlled and feasibility trial.

BACKGROUND: Improving Access to Psychological Therapies (IAPT) services treat most patients in England who present to primary care with major depression. Psychodynamic psychotherapy is one of the psychotherapies offered. Dynamic Interpersonal Therapy (DIT) is a psychodynamic and mentalization-based treatment for depression. 16 sessions are delivered over approximately 5 months. Neither DIT's effectiveness relative to low-intensity treatment (LIT), nor the feasibility of randomizing patients to psychodynamic or cognitive-behavioural treatments (CBT) in an IAPT setting has been demonstrated. METHODS: 147 patients were randomized in a 3:2:1 ratio to DIT (n = 73), LIT (control intervention; n = 54) or CBT (n = 20) in four IAPT treatment services in a combined superiority and feasibility design. Patients meeting criteria for major depressive disorder were assessed at baseline, mid-treatment (3 months) and post-treatment (6 months) using the Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures. Patients receiving DIT were also followed up 6 months post-completion. RESULTS: The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70). Significantly more DIT patients (51%) showed clinically significant change on the HRSD-17 compared with LIT (9%). The DIT and CBT arms showed equivalence on most outcomes. Results were similar with the BDI-II. DIT showed benefit across a range of secondary outcomes. CONCLUSIONS: DIT delivered in a primary care setting is superior to LIT and can be appropriately compared with CBT in future RCTs.

Barriers to recruitment when conducting a commissioned randomised controlled trial of medication versus psychological therapy for generalised anxiety disorder: some lessons learned.

BACKGROUND: Poor recruitment is the most common reason for premature discontinuation of randomised controlled trials (RCTs). An RCT of medication versus psychological therapy for generalised anxiety disorder (GAD) was discontinued prematurely by the UK National Institute of Health Research funders because of recruitment failure. In order to inform future research studies, this article explores the reasons for poor recruitment and aspects which could have been improved. METHODS: The trial recruited participants via psychological well-being practitioners (PWPs) employed within local Improving Assess to Psychological Therapies (IAPT) services at four sites in England. For this study, we initially examined the recruitment data to identify reasons why potential participants were reluctant to participate in the trial. We then investigated reasons the PWPs did not identify more potential participants. Finally, we performed retrospective analyses of a computerised clinical records system used by the IAPT services in this study. These analyses aimed to establish the number of potential participants who had not been approached about the trial as well as whether there were additional factors affecting the numbers of people who might be eligible to take part. Data were obtained for all patients assessed during the period from the date on which recruitment commenced until the closure of the trial. RESULTS: Three quarters of those patients identified as possibly suitable for the trial declined to take part; the great majority did so because they did not want to be randomly assigned to receive medication. Our retrospective database analyses showed that only around 12% of potentially eligible patients for the trial were identified by the PWPs at the pilot sites. The results also indicated that only 5% of those noted at entry to the IAPT services to have a score of at least 10 on the GAD-7 questionnaire (a self-completed questionnaire with high sensitivity and specificity for GAD) would have been eligible for the trial. CONCLUSIONS: Our findings suggest that poor recruitment to RCTs can be significantly affected by participants' treatment preferences and by factors influencing the recruiting clinicians. It may also be important not to include too many restrictions on inclusion criteria for pragmatic trials aiming for generalisable results. TRIAL REGISTRATION: ISCRTN14845583 . Registration date: 5 February 2015.

Trajectories of depression and anxiety symptom change during psychological therapy.

BACKGROUND: Forty-percent of the variance in psychological treatment outcomes is estimated to be explained by symptom change by the third treatment session. However, change may not be uniform across patient groups and symptom domains. This study aimed to identify subgroups of patients with different trajectories of depression and anxiety symptom change during psychological therapy and identify baseline patient characteristics associated with these trajectories. METHODS: 4394 patients attending two psychological treatment services completed sessional, self-report depression and anxiety measures. Trajectories of symptom change were investigated using latent class growth analysis. Multinomial logistic regression was used to explore associations between baseline patient characteristics and trajectory classes. RESULTS: A number of distinct trajectories were identified. Anxiety symptom trajectories could be distinguished by the third treatment session, but for depression symptoms there was a class displaying limited change until session six followed by rapid improvement in symptoms thereafter. Compared to the non-responding trajectories, depression and anxiety trajectories indicating treatment response were associated with lower baseline severity, better social functioning and lower incidence of phobic anxiety, but not with medication prescription status. LIMITATIONS: Data came from two services, so wider generalisability is unknown. Predictors were limited to data routinely collected in the services; unmeasured factors may have improved the prediction of trajectories. CONCLUSIONS: Baseline characteristics and symptom change early in therapy can help identify different trajectories of symptom change. This knowledge could aid clinical decision making and help improve treatment outcomes. By ignoring distinct trajectories, clinicians may incorrectly consider patients as "not-on-track" and unnecessarily change or end therapy that would otherwise benefit patients.

Effect of Digital Cognitive Behavioral Therapy for Insomnia on Health, Psychological Well-being, and Sleep-Related Quality of Life: A Randomized Clinical Trial.

Importance: Digital cognitive behavioral therapy (dCBT) is a scalable and effective intervention for treating insomnia. Most people with insomnia, however, seek help because of the daytime consequences of poor sleep, which adversely affects quality of life. Objectives: To investigate the effect of dCBT for insomnia on functional health, psychological well-being, and sleep-related quality of life and to determine whether a reduction in insomnia symptoms was a mediating factor. Design, Setting, and Participants: This online, 2-arm, parallel-group randomized trial comparing dCBT for insomnia with sleep hygiene education (SHE) evaluated 1711 participants with self-reported symptoms of insomnia. Participants were recruited between December 1, 2015, and December 1, 2016, and dCBT was delivered using web and/or mobile channels plus treatment as usual; SHE comprised a website and a downloadable booklet plus treatment as usual. Online assessments took place at 0 (baseline), 4 (midtreatment), 8 (posttreatment), and 24 (follow-up) weeks. Programs were completed within 12 weeks after inclusion. Main Outcomes and Measures: Primary outcomes were scores on self-reported measures of functional health (Patient-Reported Outcomes Measurement Information System: Global Health Scale; range, 10-50; higher scores indicate better health); psychological well-being (Warwick-Edinburgh Mental Well-being Scale; range, 14-70; higher scores indicate greater well-being); and sleep-related quality of life (Glasgow Sleep Impact Index; range, 1-100; higher scores indicate greater impairment). Secondary outcomes comprised mood, fatigue, sleepiness, cognitive failures, work productivity, and relationship satisfaction. Insomnia was assessed with the Sleep Condition Indicator (range: 0-32; higher scores indicate better sleep). Results: Of the 1711 participants included in the intention-to-treat analysis, 1329 (77.7%) were female, mean (SD) age was 48.0 (13.8) years, and 1558 (91.1%) were white. Use of dCBT was associated with a small improvement in functional health compared with SHE (adjusted difference [95% CI] at week 4, 0.90 [0.40-1.40]; week 8, 1.76 [1.24-2.28]; week 24, 1.76 [1.22-2.30]) and psychological well-being (adjusted difference [95% CI] at week 4, 1.04 [0.28-1.80]; week 8, 2.68 [1.89-3.47]; week 24, 2.95 [2.13-3.76]), and with a large improvement in sleep-related quality of life (at week 4, -8.76 [-11.83 to -5.69]; week 8, -17.60 [-20.81 to -14.39]; week 24, -18.72 [-22.04 to -15.41]) (all P < .01). A large improvement in insomnia mediated these outcomes (range mediated, 45.5%-84.0%). Conclusions and Relevance: Use of dCBT is effective in improving functional health, psychological well-being, and sleep-related quality of life in people reporting insomnia symptoms. A reduction in insomnia symptoms mediates these improvements. These results confirm that dCBT improves both daytime and nighttime aspects of insomnia, strengthening existing recommendations of CBT as the treatment of choice for insomnia. Trial Registration: isrctn.org identifier: ISRCTN60530898.

The Sleep Condition Indicator: reference values derived from a sample of 200 000 adults.

The Sleep Condition Indicator (SCI) is an eight-item rating scale that was developed to screen for insomnia disorder based on DSM-5 criteria. It has been shown previously to have good psychometric properties among several language translations. We developed age- and sex-referenced values for the SCI to assist the evaluation of insomnia in everyday clinical practice. A random sample of 200 000 individuals (58% women, mean age: 31 ± 13 years) was selected from those who had completed the SCI via several internet platforms. Descriptive and inferential methods were applied to generate reference data and indices of reliable change for the SCI for men and women across the age deciles 16-25, 26-35, 36-45, 46-55, 56-65 and 66-75 years. The mean SCI score for the full sample was 14.97 ± 5.93. Overall, women scored worse than men (14.29 ± 5.83 versus 15.90 ± 5.94; mean difference: -1.60, η2  = 0.018, Cohen's d = 0.272) and those of older age scored worse than those younger (-0.057 points per year, 95% confidence interval (CI): -0.059 to -0.055) relative to age 16-25 years. The Reliable Change Index was established at seven scale points. In conclusion, the SCI is a useful instrument for clinicians and researchers that can help them to screen for insomnia, compare completers to individuals of similar age and sex and establish whether a reliable change was achieved following treatment.

The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis.

BACKGROUND: Sleep difficulties might be a contributory causal factor in the occurrence of mental health problems. If this is true, improving sleep should benefit psychological health. We aimed to determine whether treating insomnia leads to a reduction in paranoia and hallucinations. METHODS: We did this single-blind, randomised controlled trial (OASIS) at 26 UK universities. University students with insomnia were randomly assigned (1:1) with simple randomisation to receive digital cognitive behavioural therapy (CBT) for insomnia or usual care, and the research team were masked to the treatment. Online assessments took place at weeks 0, 3, 10 (end of therapy), and 22. The primary outcome measures were for insomnia, paranoia, and hallucinatory experiences. We did intention-to-treat analyses. The trial is registered with the ISRCTN registry, number ISRCTN61272251. FINDINGS: Between March 5, 2015, and Feb 17, 2016, we randomly assigned 3755 participants to receive digital CBT for insomnia (n=1891) or usual practice (n=1864). Compared with usual practice, the sleep intervention at 10 weeks reduced insomnia (adjusted difference 4·78, 95% CI 4·29 to 5·26, Cohen's d=1·11; p<0·0001), paranoia (-2·22, -2·98 to -1·45, Cohen's d=0·19; p<0·0001), and hallucinations (-1·58, -1·98 to -1·18, Cohen's d=0·24; p<0·0001). Insomnia was a mediator of change in paranoia and hallucinations. No adverse events were reported. INTERPRETATION: To our knowledge, this is the largest randomised controlled trial of a psychological intervention for a mental health problem. It provides strong evidence that insomnia is a causal factor in the occurrence of psychotic experiences and other mental health problems. Whether the results generalise beyond a student population requires testing. The treatment of disrupted sleep might require a higher priority in mental health provision. FUNDING: Wellcome Trust.

Pilot of a randomised controlled trial of the selective serotonin reuptake inhibitor sertraline versus cognitive behavioural therapy for anxiety symptoms in people with generalised anxiety disorder who have failed to respond to low-intensity psychological treatments as defined by the National Institute for Health and Care Excellence guidelines.

BACKGROUND: Generalised anxiety disorder (GAD) is common, causing unpleasant symptoms and impaired functioning. The National Institute for Health and Care Excellence (NICE) guidelines have established good evidence for low-intensity psychological interventions, but a significant number of patients will not respond and require more intensive step 3 interventions, recommended as either high-intensity cognitive behavioural therapy (CBT) or a pharmacological treatment such as sertraline. However, there are no head-to-head comparisons evaluating which is more clinically effective and cost-effective, and current guidelines suggest that treatment choice at step 3 is based mainly on patient preference. OBJECTIVES: To assess clinical effectiveness and cost-effectiveness at 12 months of treatment with the selective serotonin reuptake inhibitor (SSRI) sertraline compared with CBT for patients with persistent GAD not improved with NICE-defined low-intensity psychological interventions. DESIGN: Participant randomised trial comparing treatment with sertraline with high-intensity CBT for patients with GAD who had not responded to low-intensity psychological interventions. SETTING: Community-based recruitment from local Improving Access to Psychological Therapies (IAPT) services. Four pilot services located in urban, suburban and semirural settings. PARTICIPANTS: People considered likely to have GAD and not responding to low-intensity psychological interventions identified at review by IAPT psychological well-being practitioners (PWPs). Those scoring ≥ 10 on the Generalised Anxiety Disorder-7 (GAD-7) anxiety measure were asked to consider involvement in the trial. INCLUSION CRITERIA: Aged ≥ 18 years, a score of ≥ 10 on the GAD-7, a primary diagnosis of GAD diagnosed on the Mini International Neuropsychiatric Interview questionnaire and failure to respond to NICE-defined low-intensity interventions. EXCLUSION CRITERIA: Inability to participate because of insufficient English or cognitive impairment, current major depression, comorbid anxiety disorder(s) causing greater distress than GAD, significant dependence on alcohol or illicit drugs, comorbid psychotic disorder, received antidepressants in past 8 weeks or high-intensity psychological therapy in previous 6 months and any contraindications to treatment with sertraline. RANDOMISATION: Consenting eligible participants randomised via an independent, web-based, computerised system. INTERVENTIONS: (1) The SSRI sertraline prescribed in therapeutic doses by the patient's general practitioner for 12 months and (2) 14 (± 2) CBT sessions delivered by high-intensity IAPT psychological therapists in accordance with a standardised manual designed for GAD. MAIN OUTCOME MEASURES: The primary outcome was the Hospital Anxiety and Depression Scale - Anxiety component at 12 months. Secondary outcomes included measures of depression, social functioning, comorbid anxiety disorders, patient satisfaction and economic evaluation, collected by postal self-completion questionnaires. RESULTS: Only seven internal pilot participants were recruited against a target of 40 participants at 7 months. Far fewer potential participants were identified than anticipated from IAPT services, probably because PWPs rarely considered GAD the main treatment priority. Of those identified, three-quarters declined participation; the majority (30/45) were reluctant to consider the possibility of randomisation to medication. LIMITATIONS: Poor recruitment was the main limiting factor, and the trial closed prematurely. CONCLUSIONS: It is unclear how much of the recruitment difficulty was a result of conducting the trial within a psychological therapy service and how much was possibly a result of difficulty identifying participants with primary GAD. FUTURE WORK: It may be easier to answer this important question by recruiting people from primary care rather than from those already engaged in a psychological treatment service. TRIAL REGISTRATION: Current Controlled Trials ISCRTN14845583. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 45. See the NIHR Journals Library website for further project information.

Digital Cognitive Behavioural Therapy for Insomnia versus sleep hygiene education: the impact of improved sleep on functional health, quality of life and psychological well-being. Study protocol for a randomised controlled trial.

BACKGROUND: Previous research has demonstrated that digital CBT (dCBT), delivered via the Internet, is a scalable and effective intervention for treating insomnia in otherwise healthy adults and leads to significant improvements in primary outcomes relating to sleep. The majority of people with insomnia, however, seek help because of the functional impact and daytime consequences of poor sleep, not because of sleep discontinuity per se. Although some secondary analyses suggest that dCBT may have wider health benefits, no adequately powered study has investigated these as a primary endpoint. This study specifically aims to investigate the impact of dCBT for insomnia upon health and well-being, and will investigate sleep-related changes as mediating factors. METHODS/DESIGN: We propose a pragmatic, parallel-group, randomised controlled trial of 1000 community participants meeting criteria for insomnia disorder. In the DIALS trial (Digital Insomnia therapy to Assist your Life as well as your Sleep), participants will be randomised to dCBT delivered using web and/or mobile channels (in addition to treatment as usual (TAU)) or to sleep hygiene education (SHE), comprising a website plus a downloadable booklet (in addition to TAU). Online assessments will take place at 0 (baseline), 4 (mid-treatment), 8 (post-treatment), and 24 (follow-up) weeks. At week 25 all participants allocated to SHE will be offered dCBT, at which point the controlled element of the trial will be complete. Naturalistic follow-up will be invited at weeks 36 and 48. Primary outcomes are functional health and well-being at 8 weeks. Secondary outcomes are mood, fatigue, sleepiness, cognitive function, productivity and social functioning. All main analyses will be carried out at the end of the final controlled follow-up assessments and will be based on the intention-to-treat principle. Further analyses will determine whether observed changes in functional health and well-being are mediated by changes in sleep. The trial is funded by Big Health Ltd. DISCUSSION: This study will be the first large-scale, specifically designed investigation of the health and well-being benefits of CBT for insomnia, and the first examination of the association between CBT-mediated sleep improvement and health status. TRIAL REGISTRATION: ISRCTN60530898 .

Predicting treatment outcome in psychological treatment services by identifying latent profiles of patients.

BACKGROUND: The outcomes of psychological therapies for anxiety and depression vary across individuals and symptom domains. Being able to predict treatment response from readily available patient data at presentation has potentially important benefits in aiding decisions about the most suitable interventions for a patient. This paper presents a method of identifying subgroups of patients using latent profile analysis, and comparing response to psychological treatments between these profiles. METHODS: All outpatients taken into treatment at two psychological treatment services in London, UK and who provided basic demographic information and standardized symptom measures were included in the analysis (n=16636). RESULTS: Latent Profile Analysis was performed on intake data to identify statistically different groups of patients, which were then examined in longitudinal analyses to determine their capacity to predict treatment outcomes. Comparison between profiles showed considerable variation in recovery (74-15%), deterioration rates (5-20%), and levels of attrition (17-40%). Further variation in outcomes was found within the profiles when different intensities of psychological intervention were delivered. LIMITATIONS: Latent profiles were identified using data from two services, so generalisability to other services should be considered. Routinely collected patient data was included, additional patient information may further enhance utility of the profiles. CONCLUSIONS: These results suggest that intake data can be used to reliably classify patients into profiles that are predictive of outcome to different intensities of psychological treatment in routine care. Algorithms based on these kinds of data could be used to optimize decision-making and aid the appropriate matching of patients to treatment.

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

BACKGROUND: Collaborative care is effective for depression management in the USA. There is little UK evidence on its clinical effectiveness and cost-effectiveness. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of collaborative care compared with usual care in the management of patients with moderate to severe depression. DESIGN: Cluster randomised controlled trial. SETTING: UK primary care practices (n = 51) in three UK primary care districts. PARTICIPANTS: A total of 581 adults aged ≥ 18 years in general practice with a current International Classification of Diseases, Tenth Edition depressive episode, excluding acutely suicidal people, those with psychosis, bipolar disorder or low mood associated with bereavement, those whose primary presentation was substance abuse and those receiving psychological treatment. INTERVENTIONS: Collaborative care: 14 weeks of 6-12 telephone contacts by care managers; mental health specialist supervision, including depression education, medication management, behavioural activation, relapse prevention and primary care liaison. Usual care was general practitioner standard practice. MAIN OUTCOME MEASURES: Blinded researchers collected depression [Patient Health Questionnaire-9 (PHQ-9)], anxiety (General Anxiety Disorder-7) and quality of life (European Quality of Life-5 Dimensions three-level version), Short Form questionnaire-36 items) outcomes at 4, 12 and 36 months, satisfaction (Client Satisfaction Questionnaire-8) outcomes at 4 months and treatment and service use costs at 12 months. RESULTS: In total, 276 and 305 participants were randomised to collaborative care and usual care respectively. Collaborative care participants had a mean depression score that was 1.33 PHQ-9 points lower [n = 230; 95% confidence interval (CI) 0.35 to 2.31; p = 0.009] than that of participants in usual care at 4 months and 1.36 PHQ-9 points lower (n = 275; 95% CI 0.07 to 2.64; p = 0.04) at 12 months after adjustment for baseline depression (effect size 0.28, 95% CI 0.01 to 0.52; odds ratio for recovery 1.88, 95% CI 1.28 to 2.75; number needed to treat 6.5). Quality of mental health but not physical health was significantly better for collaborative care at 4 months but not at 12 months. There was no difference for anxiety. Participants receiving collaborative care were significantly more satisfied with treatment. Differences between groups had disappeared at 36 months. Collaborative care had a mean cost of £272.50 per participant with similar health and social care service use between collaborative care and usual care. Collaborative care offered a mean incremental gain of 0.02 (95% CI -0.02 to 0.06) quality-adjusted life-years (QALYs) over 12 months at a mean incremental cost of £270.72 (95% CI -£202.98 to £886.04) and had an estimated mean cost per QALY of £14,248, which is below current UK willingness-to-pay thresholds. Sensitivity analyses including informal care costs indicated that collaborative care is expected to be less costly and more effective. The amount of participant behavioural activation was the only effect mediator. CONCLUSIONS: Collaborative care improves depression up to 12 months after initiation of the intervention, is preferred by patients over usual care, offers health gains at a relatively low cost, is cost-effective compared with usual care and is mediated by patient activation. Supervision was by expert clinicians and of short duration and more intensive therapy may have improved outcomes. In addition, one participant requiring inpatient treatment incurred very significant costs and substantially inflated our cost per QALY estimate. Future work should test enhanced intervention content not collaborative care per se. TRIAL REGISTRATION: Current Controlled Trials ISRCTN32829227. FUNDING: This project was funded by the Medical Research Council (MRC) (G0701013) and managed by the National Institute for Health Research (NIHR) on behalf of the MRC-NIHR partnership.

Cost-effectiveness of collaborative care for depression in UK primary care: economic evaluation of a randomised controlled trial (CADET).

BACKGROUND: Collaborative care is an effective treatment for the management of depression but evidence on its cost-effectiveness in the UK is lacking. AIMS: To assess the cost-effectiveness of collaborative care in a UK primary care setting. METHODS: An economic evaluation alongside a multi-centre cluster randomised controlled trial comparing collaborative care with usual primary care for adults with depression (n = 581). Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICER) were calculated over a 12-month follow-up, from the perspective of the UK National Health Service and Personal Social Services (i.e. Third Party Payer). Sensitivity analyses are reported, and uncertainty is presented using the cost-effectiveness acceptability curve (CEAC) and the cost-effectiveness plane. RESULTS: The collaborative care intervention had a mean cost of £272.50 per participant. Health and social care service use, excluding collaborative care, indicated a similar profile of resource use between collaborative care and usual care participants. Collaborative care offered a mean incremental gain of 0.02 (95% CI: -0.02, 0.06) quality-adjusted life-years over 12 months, at a mean incremental cost of £270.72 (95% CI: -202.98, 886.04), and resulted in an estimated mean cost per QALY of £14,248. Where costs associated with informal care are considered in sensitivity analyses collaborative care is expected to be less costly and more effective, thereby dominating treatment as usual. CONCLUSION: Collaborative care offers health gains at a relatively low cost, and is cost-effective compared with usual care against a decision-maker willingness to pay threshold of £20,000 per QALY gained. Results here support the commissioning of collaborative care in a UK primary care setting.

The Sleep Condition Indicator: a clinical screening tool to evaluate insomnia disorder.

OBJECTIVE: Describe the development and psychometric validation of a brief scale (the Sleep Condition Indicator (SCI)) to evaluate insomnia disorder in everyday clinical practice. DESIGN: The SCI was evaluated across five study samples. Content validity, internal consistency and concurrent validity were investigated. PARTICIPANTS: 30 941 individuals (71% female) completed the SCI along with other descriptive demographic and clinical information. SETTING: Data acquired on dedicated websites. RESULTS: The eight-item SCI (concerns about getting to sleep, remaining asleep, sleep quality, daytime personal functioning, daytime performance, duration of sleep problem, nights per week having a sleep problem and extent troubled by poor sleep) had robust internal consistency (α≥0.86) and showed convergent validity with the Pittsburgh Sleep Quality Index and Insomnia Severity Index. A two-item short-form (SCI-02: nights per week having a sleep problem, extent troubled by poor sleep), derived using linear regression modelling, correlated strongly with the SCI total score (r=0.90). CONCLUSIONS: The SCI has potential as a clinical screening tool for appraising insomnia symptoms against Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.