A randomized controlled trial of a digital cognitive-behavioral therapy program (COMPASS) for managing depression and anxiety related to living with a long-term physical health condition.

BACKGROUND: To evaluate the clinical efficacy of COMPASS, a therapist-supported digital therapeutic for reducing psychological distress (anxiety/depression) in people living with long-term physical health conditions (LTCs). METHODS: A two-armed randomized-controlled trial recruiting from LTC charities. Participants with anxiety and/or depression symptoms related to their LTC(s) were randomized (concealed allocation via independent administrator) to COMPASS (access to 11 tailored modules plus five thirty-minute therapist support sessions) or standard charity support (SCS). Assessments were completed online pre-randomization, at 6- and 12-weeks post-randomization. Primary outcome was Patient Health Questionnaire Anxiety and Depression Scale; PHQ-ADS measured at 12-weeks. Analysis used intention-to-treat principles with adjusted mean differences estimated using linear mixed-effects models. Data-analyst was blinded to group allocation. RESULTS: 194 participants were randomized to COMPASS (N = 94) or SCS (N = 100). At 12-weeks, mean level of psychological distress was 6.82 (95% confidence interval; CI 4.55-9.10) points lower (p < 0.001) in the COMPASS arm compared with SCS (standardized mean difference of 0.71 (95% CI 0.48-0.95)). The COMPASS arm also showed moderate significant treatment effects on secondary outcomes including depression, anxiety and illness-related distress and small significant effects on functioning and quality-of-life. Rates of adverse events were comparable across the arms. Deterioration in distress at 12-weeks was observed in 2.2% of the SCS arm, and no participants in the COMPASS arm. CONCLUSION: Compared with SCS, COMPASS digital therapeutic with minimal therapist input reduces psychological distress at post-treatment (12-weeks). COMPASS offers a potentially scalable implementation model for health services but its translation to these contexts needs further evaluating. TRIAL REGISTRATION: NCT04535778.

A cognitive-behavioural therapy programme for managing depression and anxiety in long-term physical health conditions: mixed-methods real-world evaluation of the COMPASS programme.

BACKGROUND: Mental health comorbidities are common in physical long-term health conditions. AIMS: We evaluate the effectiveness of COMPASS, a therapist-supported, digital cognitive-behavioural therapy programme specifically designed to treat anxiety/depression in the context of long-term conditions. We also investigate patient experiences of the programme. METHOD: We utilised a mixed-methods, non-randomised design. We analysed pre-post data from 76 patients with long-term conditions who were receiving psychological treatment (COMPASS) via local NHS services, using paired sample t-tests and Cohen's d, with depression, anxiety, distress and functional impairment self-report scales. Qualitative interviews explored patients' experiences of using COMPASS. Twenty-one semi-structured interviews were completed and underwent inductive thematic analysis. RESULTS: Patients who received COMPASS had significantly reduced depression (-2.47, 95% CI -3.7 to -1.3, P < 0.001; Cohen's d = -0.376), anxiety (-2.30, 95% CI -3.6 to -1.2, P < 0.001; Cohen's d = -0.420) and psychological distress (-4.87, 95% CI -7.0 to -2.7, P < 0.001; Cohen's d = -0.422) and significantly improved functional impairment (-3.00, 95% CI -4.8 to -1.2, P ≤ 0.001; Cohen's d = -0.282). Effect sizes were larger when analyses included only patients with clinically significant baseline symptoms: depression (-4.02, 95% CI -5.6 to -2.5, P < 0.001; Cohen's d = -0.701), anxiety (-3.60, 95% CI -5.3 to -1.9, P < 0.001; Cohen's d = -0.739), psychological distress (-5.58, 95% CI -7.9 to -3.2, P < 0.001; Cohen's d = -0.523), functional impairment (-3.28, 95% CI -5.4 to -1.1, P ≤ 0.001; Cohen's d = -0.355). Qualitative analysis yielded two meta-themes: engagement and integration of mental and physical health. CONCLUSIONS: Results suggest that COMPASS is effective in NHS settings, and is acceptable to patients. Content tailored to long-term conditions, therapist support and clear delivery strategies should be prioritised to aid intervention implementation.

Mental health outcomes in patients with a long-term condition: analysis of an Improving Access to Psychological Therapies service.

BACKGROUND: Having a long-term condition (LTC) significantly affects mental health. UK policy requires effective mental health provisions for patients with an LTC, generally provided by Improving Access to Psychological Therapies (IAPT) services. National IAPT data suggest that patients with an LTC typically demonstrate poorer outcomes compared with patients without an LTC. However, exploration of confounding factors and different outcome variables is limited. AIMS: To establish the association of LTC status with demographic and clinical factors, and clinical mental health outcomes. METHOD: Anonymised patient-level data from a London IAPT service during January 2019 to October 2020 were used in this cohort study, to compare differences between LTC and non-LTC groups on sociodemographic and clinical variables. Binary logistic and multiple linear regression models were constructed for binary outcome variables (recovery and reliable improvement) and continuous outcomes (distress and functioning), respectively. RESULTS: Patients with an LTC were more likely to be female; older; from a Black, mixed or other ethnic background; and have greater social deprivation. Across the four clinical outcomes (recovery, reliable improvement, final psychological distress and final functioning), having an LTC significantly predicted poorer outcomes even after controlling for sociodemographic and clinical baseline variables. For three outcome variables, greater social deprivation and being discharged during the COVID-19 pandemic also predicted poorer clinical outcomes. CONCLUSIONS: LTC status has a negative effect on mental health outcomes in IAPT services, independent of associated variables such as severity of baseline mental health symptoms, ethnicity and social deprivation. Effective psychological treatment for patients with an LTC remains an unresolved priority.

An Evidence-Based Theory of Psychological Adjustment to Long-Term Physical Health Conditions: Applications in Clinical Practice.

OBJECTIVE: Around 30% of people with long-term physical health conditions (LTCs) experience comorbid anxiety and depression. For many, comorbid distress is linked to difficulties adjusting to the challenges of the LTC. The aims of this article are to present a transdiagnostic theoretical model of adjustment to LTCs (TMA-LTC), demonstrate the application of this model in clinical practice, and highlight the distinguishing features of treating LTC-related distress compared with treating primary anxiety and/or depression. METHODS: A systematic review (k = 21) was conducted to collate preexisting evidence-based models of adjustment across LTCs. Models of adjustment for a range of LTCs were extracted and synthesized into a new preliminary TMA-LTC. Two expert consensus meetings were held, where experts rated the relevance and importance of all concepts within the models. RESULTS: The TMA-LTC proposes that acute critical events or ongoing illness stressors can disrupt emotional equilibrium, and that whether a person returns to equilibrium and achieves good psychological adjustment depends on a number of cognitive and behavioral factors, as well as their interpersonal, intrapersonal, environmental, and illness-specific contexts. A case study is presented to demonstrate the clinical application of this model in treating illness-related distress, highlighting how it overcomes roadblocks that may be encountered when working primarily within traditional mental health paradigms. CONCLUSIONS: As an empirically and clinically informed model, TMA-LTC provides a useful guide for assessment, formulation, and treatment in the context of psychological adjustment to LTCs. Future studies are needed to test treatments that have been developed based on TMA-LTC.

Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial.

INTRODUCTION: Approximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS). METHODS AND ANALYSIS: A two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed. ETHICS AND DISSEMINATION: The study is approved by King's College London's Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20-20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: NCT04535778.

Therapists' perceptions of barriers and facilitators to uptake and engagement with therapy in long-term conditions.

OBJECTIVE: Improving Access to Psychological Therapies (IAPT) services in England have established a long-term condition (LTC) pathway in recent years, meaning that LTC therapies are now delivered via varied modes and by professionals with varied experiences. To gain insight into how this new pathway is functioning in practice, this study aimed to explore therapists' perceptions of barriers and facilitators to uptake and engagement with therapy in LTCs. DESIGN: A qualitative design was employed using semi-structured interviews. METHODS: Fifteen therapists were recruited from IAPT and physical health care settings. Interviews were first analysed using inductive thematic analysis. A deductive approach was then taken to map themes onto Normalisation Process Theory constructs (coherence, cognitive participation, collective action, reflective monitoring) to guide steps towards improving implementation. RESULTS: Four key themes highlighted patient, therapist, and service-level factors related to uptake and engagement: Working flexibly with barriers within the National Health Service context; Acceptability of 'embedded' versus 'separate' psychological care; Confidence in working with people with LTCs; and Navigating implementation of online therapies. Therapists recognized the need for tailored LTC therapies, though opinions about online therapies varied. Therapists expressed commitment to flexibly adapting their practice to suit patient needs, but felt their flexibility was limited by system and service constraints. CONCLUSION: Barriers to uptake and engagement need to be addressed to optimize LTC pathways. Findings demonstrated the importance of offering flexible, tailored therapy to people with LTCs, and equipping staff and services with adequate training and resources to improve functioning of LTC pathways in practice.

Subacute fatigue in primary care - two sides of the story.

OBJECTIVES: Fatigue is a common symptom in primary care. Chronic fatigue research highlights the value of preventing chronicity, but little research has investigated the early, subacute stage of the fatigue trajectory (<3 months). We aimed to examine patient and general practitioner (GP) perspectives of subacute fatigue in primary care: (1) to gain a better understanding of fatigue during this stage and (2) to explore how management could be improved. DESIGN: A qualitative study design was used. In-depth, semi-structured telephone interviews were conducted with 14 patients and 14 GPs (non-dyadic), recruited from 19 primary care practices. METHODS: Interview transcripts were thematically analysed. Initially, patient and GP accounts were analysed separately, before themes were merged to identify shared and independent perspectives. RESULTS: Three main themes were identified. Within these, subthemes from patients', GPs', or shared patient/GP perspectives emerged. The main themes encompassed the following: (1) Change from normal - the impact of fatigue; (2) The challenges of managing fatigue; and (3) The consultation GPs' knowledge was often not reflected in patients' accounts, even for those reporting positive experiences, suggesting knowledge was not effectively translated. CONCLUSIONS: Some findings, such as impact, mirror those described in chronic fatigue. New insights into early-stage fatigue management also arose, including mismatches in patient and GP perceptions on negative tests and not re-presenting. These highlight the need for better communication and shared understanding. GPs should pre-emptively present a biopsychosocial model of fatigue and keep communication channels open, particularly in the light of negative physiological tests. Statement of contribution What is already known on this subject? Patients with chronic fatigue retrospectively report lack of understanding from GPs in early stage of illness. Little research has investigated the early stages of the fatigue trajectory. What does this study add? Consequences of an episode of subacute fatigue are similar to those reported for CFS. There is discordance between GPs' positive view of negative tests and patients' need for explanation of symptoms. The length of appointments is a significant barrier for creating shared understanding.

'Chronic cough, cause unknown': A qualitative study of patient perspectives of chronic refractory cough.

Chronic refractory cough patients have persistent, unexplained, treatment-resistant symptoms. Very little is known about non-physiological processes underlying chronic refractory cough or patients' experience of the condition. In all, 14 patients participated in semi-structured interviews. Interviews were based on the comprehensive cognitive behavioural model and analysed thematically. Eight key themes emerged illustrating that the experience of the onset and persistence of chronic refractory cough is complex, often involving multiple interlinking factors. Themes highlighted the involvement of biological and psychological factors, and the prominent role of the social dimension in how the cough is experienced, perceived and managed. Implications for intervention development are discussed.

Fatigue interventions in long term, physical health conditions: A scoping review of systematic reviews.

OBJECTIVE: Fatigue is prominent across many long term physical health conditions. This scoping review aimed to map the fatigue intervention literature, to ascertain if certain interventions may be effective across conditions, and if novel interventions tested in specific long term conditions may be promising for other conditions. METHODS: Scoping review methodological frameworks were used. Electronic bibliographic databases were searched (inception to November 2016) for systematic reviews of fatigue interventions in long term conditions. Inclusion criteria were: long term physical health condition; review focus on fatigue management; objective and systematic review process; primary review outcome is fatigue. Articles focussing on surgical interventions or treatments thought to trigger fatigue were excluded. A narrative synthesis was performed. RESULTS: Of 115 full texts screened, 52 reviews were included. Interventions were categorised as pharmacological and non-pharmacological (exercise, psychological/behavioural and complementary medicine). Pharmacological interventions did not consistently demonstrate benefit, except for anti-TNFs and methylphenidate which may be effective at reducing fatigue. Non-pharmacological interventions such as graded exercise and fatigue-specific psychological interventions may be effective, but heterogeneous intervention components limit conclusions. 'Complementary medicine' interventions (e.g. Chinese herbal medicines) showed promise, but the possibility of publication bias must be considered. CONCLUSIONS: Further research is necessary to inform clinical practice. The reported effectiveness of some interventions across inflammatory health conditions, such as anti-TNFs, aerobic exercise, and psychologically based approaches such as CBT, highlights a potential transdiagnostic avenue for fatigue management. More novel strategies that may be worth exploring include expressive writing and mindfulness, although the mechanisms for these in relation to fatigue are unclear. More work is needed to identify transdiagnostic mechanisms of fatigue and to design interventions based on these.

Doctor-patient relationship and quality of life in Irritable Bowel Syndrome: an exploratory study of the potential mediating role of illness perceptions and acceptance.

Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disorder characterised by unpredictable bowel symptoms. These can be difficult to manage, consequently impacting quality of life (QoL). In addition, a strained doctor-patient relationship is independently reported in the qualitative literature. Given the doctor is often the first port of call for people with IBS, a difficult relationship may influence subsequent IBS management. Research suggests illness perceptions are important in determining IBS outcomes in therapy; however, their association with doctor-patient relationship and QoL is yet to be investigated. This exploratory study aimed to investigate the association between these constructs in IBS, as well as potential mediation by illness perceptions. Online questionnaires measuring doctor-patient relationship, illness perceptions, acceptance and QoL, were completed by 167 participants who reported an IBS diagnosis (144 female, mean age = 44.22 years, SD = 15.91 years). Bootstrapped pathway analysis was used to model the relationship and mediation effects. There was a significant positive correlation between patient-doctor relationship and QoL, r = .258, n = 167, p = .001. There was a significant indirect effect between doctor-patient relationship and QoL through illness coherence and acceptance (bootstrapped estimate = .058, 95%CI Lower-Upper = .02, .095, p = .002). No other indirect effects were observed in combination with good fit indices for the other illness perceptions. Findings suggest a doctor-patient relationship which fosters mutual understanding and helps patients make sense of symptoms, increases their ability to manage their IBS in a psychologically flexible manner, subsequently helping them maintain their QoL.

Biopsychosocial risk factors of persistent fatigue after acute infection: A systematic review to inform interventions.

OBJECTIVES: Fatigue is a prevalent and debilitating symptom, preceded by an acute infectious episode in some patients. This systematic review aimed to identify risk factors for the development of persistent fatigue after an acute infection, to develop an evidence-based working model of post-infectious fatigue. METHODS: Electronic databases (Medline, PsycINFO and EMBASE) were searched, from inception to March 2016, for studies which investigated biopsychosocial risk factors of on-going fatigue after an acute infection. Inclusion criteria were: prospective design; biological, psychological or social risk factors; standardised measure of post-infectious fatigue (self-report scales or clinical diagnosis). Studies were excluded if the sample had a pre-existing medical condition, infection was conceptualised as 'vaccination' or they were intervention trials. A narrative synthesis was performed. RESULTS: Eighty-one full texts were screened, of which seventeen were included in the review. Over half included glandular fever populations. Other infections included dengue fever, 'general'/'viral' and Q-fever. Risk factors were summarised under biological, social, behavioural, cognitive and emotional subthemes. Patients' cognitive and behavioural responses to the acute illness, and pre-infection or baseline distress and fatigue were the most consistent risk factors for post-infectious fatigue. CONCLUSION: An empirical summary model is provided, highlighting the risk factors most consistently associated with persistent fatigue. The components of the model, the possible interaction of risk factors and implications for understanding the fatigue trajectory and informing preventative treatments are discussed.

Psychological profile of individuals presenting with chronic cough.

Chronic refractory cough (CRC) is a common problem in respiratory clinics. Adverse effects on quality of life are documented in the literature, but relatively little is known about the underlying psychological factors in this patient population. We aimed to investigate the association of psychological factors with chronic cough, comparing CRC to explained cough and non-cough groups. 67 patients attending a specialist cough clinic (CRC, n=25; explained cough, n=42) and 22 non-cough individuals participated. All participants completed the Hospital Anxiety & Depression Scale, Big Five Inventory (Personality), Chalder Fatigue Scale and Patient Health Questionnaire-15. Cough patients also completed the Illness Perception Questionnaire-Revised. Appropriate statistical analyses were used to compare participant groups. Chronic refractory coughers displayed significantly higher levels of anxiety, depression, fatigue and somatic physical symptoms than non-cough participants. Compared to explained coughers, there were higher depression and fatigue scores and significantly more negative illness representations (specifically, strong beliefs regarding negative consequences, lower illness coherence and higher emotional representations). "Explained" coughers reported significantly increased fatigue and somatic symptoms in comparison to non-coughers. The prevalence of fatigue, low mood, negative illness beliefs and increased physical symptom reporting should be considered in consultations and in developing novel interventions for CRC patients.