Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT).

BACKGROUND: Anxiety and depression are common among patients attending cardiac rehabilitation services. Currently available pharmacological and psychological interventions have limited effectiveness in this population. There are presently no psychological interventions for anxiety and depression integrated into cardiac rehabilitation services despite emphasis in key UK National Health Service policy. A new treatment, metacognitive therapy, is highly effective at reducing anxiety and depression in mental health settings. The principal aims of the current study are (1) to evaluate the acceptability of delivering metacognitive therapy in a home-based self-help format (Home-MCT) to cardiac rehabilitation patients experiencing anxiety and depressive symptoms and conduct a feasibility trial of Home-MCT plus usual cardiac rehabilitation compared to usual cardiac rehabilitation; and (2) to inform the design and sample size for a full-scale trial. METHODS: The PATHWAY Home-MCT trial is a single-blind feasibility randomised controlled trial comparing usual cardiac rehabilitation (control) versus usual cardiac rehabilitation plus home-based self-help metacognitive therapy (intervention). Economic and qualitative evaluations will be embedded within the trial. Participants will be assessed at baseline and followed-up at 4 and 12 months. Patients who have been referred to cardiac rehabilitation programmes and have a score of ≥ 8 on the anxiety and/or depression subscales of the Hospital Anxiety and Depression Scale will be invited to take part in the study and written informed consent will be obtained. Participants will be recruited from the National Health Service in the UK. A minimum of 108 participants will be randomised to the intervention and control arms in a 1:1 ratio. DISCUSSION: The Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03129282 , Submitted to Registry: 11 April 2017.

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial.

BACKGROUND: Anxiety and depression are prevalent among cardiac rehabilitation patients but pharmacological and psychological treatments have limited effectiveness in this group. Furthermore, psychological interventions have not been systematically integrated into cardiac rehabilitation services despite being a strategic priority for the UK National Health Service. A promising new treatment, metacognitive therapy, may be well-suited to the needs of cardiac rehabilitation patients and has the potential to improve outcomes. It is based on the metacognitive model, which proposes that a thinking style dominated by rumination, worry and threat monitoring maintains emotional distress. Metacognitive therapy is highly effective at reducing this thinking style and alleviating anxiety and depression in mental health settings. This trial aims to evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy for cardiac rehabilitation patients with elevated anxiety and/or depressive symptoms. METHODS/DESIGN: The PATHWAY Group-MCT trial is a multicentre, two-arm, single-blind, randomised controlled trial comparing the clinical- and cost-effectiveness of group-based metacognitive therapy plus usual cardiac rehabilitation to usual cardiac rehabilitation alone. Cardiac rehabilitation patients (target sample n = 332) with elevated anxiety and/or depressive symptoms will be recruited across five UK National Health Service Trusts. Participants randomised to the intervention arm will receive six weekly sessions of group-based metacognitive therapy delivered by either cardiac rehabilitation professionals or research nurses. The intervention and control groups will both be offered the usual cardiac rehabilitation programme within their Trust. The primary outcome is severity of anxiety and depressive symptoms at 4-month follow-up measured by the Hospital Anxiety and Depression Scale total score. Secondary outcomes are severity of anxiety/depression at 12-month follow-up, health-related quality of life, severity of post-traumatic stress symptoms and strength of metacognitive beliefs at 4- and 12-month follow-up. Qualitative interviews will help to develop an account of barriers and enablers to the effectiveness of the intervention. DISCUSSION: This trial will evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy in alleviating anxiety and depression in cardiac rehabilitation patients. The therapy, if effective, offers the potential to improve psychological wellbeing and quality of life in this large group of patients. TRIAL REGISTRATION: UK Clinical Trials Gateway, ISRCTN74643496 , Registered on 8 April 2015.

The association of metacognitive beliefs with emotional distress and trauma symptoms in adolescent and young adult survivors of cancer.

PURPOSE/OBJECTIVES: Adolescent and young adults who have survived cancer are at an increased risk of psychological distress. This study investigated whether metacognitive beliefs are associated with emotional distress and trauma symptoms in adolescent and young adult (AYA) survivors of cancer independent of known covariates, including current physical health difficulties. DESIGN: Cross-sectional survey using multiple self-report measures. SAMPLE AND METHODS: Eighty-seven AYA survivors of cancer were recruited from follow-up appointments at an oncology unit and completed self-report questionnaires measuring emotional distress, posttraumatic stress symptoms, metacognitive beliefs, demographic information, and current physical health difficulties. Data were analysed using correlational and hierarchical multiple regression analyses. FINDINGS: Metacognitive beliefs explained an additional 50% and 41% of the variance in emotional distress and posttraumatic stress symptoms, respectively, after controlling for known covariate effects, including current physical health difficulties. Conclusions/Implications for Psychosocial Providers or Policy: The metacognitive model of psychopathology is potentially applicable to AYA survivors of cancer who present with elevated general distress and/or posttraumatic stress symptoms. Prospective studies are required to determine whether metacognitive beliefs and processes have a causal role in distress in AYA survivors of cancer.

Alleviating Emotional Distress in Adolescent and Young Adult Cancer Survivors: An Open Trial of Metacognitive Therapy.

PURPOSE: Metacognitive therapy (MCT) is an effective psychological treatment for a range of emotional disorders. However, the applicability of MCT to treating emotional distress in physical health populations has yet to be tested. The present study examined the potential of MCT for alleviating emotional distress in adolescent and young adult cancer (AYAC) survivors. METHODS: Twelve AYAC survivors, aged 18-23, who had completed acute medical treatment participated in this pilot open trial with 6 months follow-up. Each participant completed a baseline period followed by 8-14 sessions of MCT that targeted perseverative thinking (worry and rumination), attentional control, and metacognitive beliefs. The primary outcome variable was severity of depression and anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). RESULTS: MCT was associated with large and statistically significant reductions in anxiety, depression, trauma symptoms, and metacognitive beliefs and processes. In the intention-to-treat sample, 50% of participants met standardized criteria for recovery on the HADS at posttreatment and these gains were maintained through to 6-month follow-up. CONCLUSION: MCT is a promising transdiagnostic approach to treating different forms of emotional distress in AYAC survivors. Further investigation in controlled trials is now warranted.

Anxiety in a neglected population: prevalence of anxiety disorders in pre-adolescent children.

It is widely believed that anxiety is a common disorder of childhood and adolescence, but epidemiological studies have varied substantially in the prevalence rates that they report. In addition, less attention has been paid to the prevalence of anxiety in pre-adolescent children. For these reasons, a review of epidemiological studies reporting on the prevalence of anxiety disorders in this younger population is described. A comprehensive literature search, encompassing electronic searches of databases and hand searches of journals, returned 11 studies that reported on the prevalence of DSM-III-R or DSM-IV anxiety, specifically in children aged below 12 years of age, which had employed certain minimum standards of epidemiological practice, and had some degree of generalisability to wider populations. The rates of diagnosis of 'any anxiety disorder' varied widely between the studies. The minimum figure reported was 2.6%, and the maximum was 41.2%. Separation Anxiety Disorder appeared to be the most common individual anxiety diagnosis in this age group. Anxiety disorders appear to be more common than depressive disorders, and probably also more common than disorders of behaviour. Anxiety disorders are, at the very least, fairly common in pre-adolescent children. This is concerning when the limited current treatment options for this age group are considered. Reasons for the varied prevalence rates reported by the studies, focussing on the differences in methods employed, are suggested. Implications for treatment are discussed.