The COMFORT trial: a randomised control trial comparing group-based COMpassion-FOcussed therapy and breathing pattern ReTraining with treatment as usual on the psychological functioning of patients diagnosed with cancer recurrence during COVID.

BACKGROUND: A cancer diagnosis is a known precipitant of psychological distress, with fear of recurrence being a well-documented distressing consequence of cancer. Cancer recurrence often results in an additional psychological burden, which may exacerbate as a result of the COVID-19 pandemic. METHODS: This is a single-centre, prospective, randomised controlled trial. Patients identified as having experienced cancer recurrence since March 2020 (the onset of the COVID-19 pandemic in Ireland) will be screened for participation. Eligible, consenting candidates who score 4 or higher on the Distress Thermometer will be enrolled in the study. Participants will be randomly allocated to receive either a 6-week, group-based, online, compassion-focussed therapy and breathing pattern retraining intervention or the control arm. Those in the control arm will all be offered the group intervention after the 18-week study period. The primary outcome is the Distress Thermometer score at 18 weeks post-baseline though secondary outcomes will include measures of mood, traumatic distress and mental adjustment to cancer. DISCUSSION: To our knowledge, this protocol describes the first RCT which directly examines the effect of a group-based psychological intervention on Irish patients experiencing cancer recurrence in the context of COVID-19. The outcome of this trial is likely to be twofold: It will determine if the psychological intervention achieves its primary objective of distress amelioration 3 months post-intervention and to establish the feasibility of delivering this intervention in a virtual format. TRIAL REGISTRATION: ClinicalTrials.gov NCT05518591. Registered on 25 August 2022. All items from the World Health Organization Trial Registration Data set have been included.

Effect of perioperative cognitive behavioural therapy on chronic post-surgical pain among breast cancer patients with high pain catastrophising characteristics: protocol for a double-blinded randomised controlled trial.

BACKGROUND: Surgery is regarded as the primary treatment for breast cancer. Chronic post-surgical pain (CPSP) is a recognised complication after breast cancer surgery, and it is estimated to affect 20-30% of women. Pain catastrophizing has emerged as one of the most influential psychological variables associated with CPSP. METHODS: This trial will be a single-centre, prospective, double-blinded, superiority, randomised controlled trial (RCT). Patients scheduled for elective breast cancer surgery (wide local excision or mastectomy with or without axillary lymph node dissection) will be screened preoperatively for high pain catastrophising. Patients with high pain catastrophising, defined as a score of ≥ 24 on the Pain Catastrophising Scale will be deemed eligible for inclusion in the study. Participants will be randomly assigned to receive either a cognitive behavioural therapy or an educational mindfulness based programme during their perioperative period. The primary outcome is the Brief Pain Inventory short form average pain severity score at 3 months postoperatively. Secondary outcomes include patient-reported quality of recovery at days 1-2 after surgery, levels of pain catastrophising, reported depressed mood and anxiety. DISCUSSION: To the best of our knowledge, this protocol describes the first RCT which directly examines the effect of perioperative cognitive behavioural therapy on CPSP among breast cancer patients with high pain catastrophising characteristics. The outcomes of this trial may have significant implications for these patients because perioperative cognitive behavioural therapy has the potential to become an important perioperative intervention to complement patient management. TRIAL REGISTRATION: ClinicalTrials.gov NCT04924010 . Registered on 11 June 2021. All item from the World Health Organisation Trial Registration Data set have been included.

Investigating the impact of a chronic disease self-management programme on depression and quality of life scores in an Irish sample.

Depression is more common among people with chronic conditions than in the general population and can negatively influence both health behaviours and outcomes. The Chronic Disease Self-Management Programme (CDSMP) is a six-week psycho-educational programme designed to promote self-efficacy and to teach patients skills for managing their chronic conditions. A longitudinal design evaluated the effect of the CDSMP on depression in an Irish cohort. Self-report data on psychological wellbeing were collected at baseline (n = 263), immediately post-program (n = 102), and six months (n = 81) after enrolment. CDSMP participation was associated with a significant decrease in the mean depression score of the whole sample, across the three time points. Significant improvements in quality of life and health interference in social activities were also observed among those who met criteria for depression on the PHQ-8 at baseline, but not their peers with sub-threshold depression scores. Quality of life continued to improve between the end of the programme and 6-month follow-up. These findings support the efficacy of the CDSMP in the treatment of chronic conditions, as well as its role in promoting sustainable changes to quality of life.

Exercise combined with Acceptance and Commitment Therapy compared with a standalone supervised exercise programme for adults with chronic pain: a randomised controlled trial.

ABSTRACT: A prospective, 2-armed, parallel group randomised controlled trial (RCT) was conducted to compare the effectiveness of Acceptance and Commitment Therapy (ACT) combined with a supervised exercise programme with a supervised exercise programme alone for adults with chronic pain. One hundred seventy-five participants were individually randomised to receive either the combined Exercise and ACT (ExACT) intervention or supervised exercise alone. Those allocated to the ExACT group attended 8 weekly sessions with a psychologist based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group attended weekly supervised exercise classes but did not take part in an ACT programme. Both groups were followed up postintervention and again after 12 weeks. The primary outcome was pain interference at 12-week follow-up. Estimates of treatment effects at follow-up were based on intention-to-treat analyses, implemented using a linear mixed-effects model. The findings of this RCT showed no difference in the effectiveness of ExACT, compared with a supervised exercise programme alone for the primary outcome pain interference at 12-week follow-up (mean difference -0.18, 95% confidence interval -0.84 to 0.48, P = 0.59, d = 0.11). ExACT group participants reported superior outcomes for pain self-efficacy, pain catastrophising, and committed action, compared with the control group, but there were no differences between the groups for other secondary outcomes or treatment process measures. Higher levels of treatment satisfaction and global impression of change were reported by ExACT group participants. Exercise combined with Acceptance and Commitment Therapy was not superior to a standalone supervised exercise programme for reducing pain interference in adults with chronic pain.

Exercise and Acceptance and Commitment Therapy for Chronic Pain: A Case Series with One-Year Follow-Up.

INTRODUCTION: There is growing evidence to support Acceptance and Commitment Therapy (ACT) in the management of chronic pain. However, there is a need for further research evaluating ACT combined with physical exercise, and few studies have assessed the long-term impact of this type of intervention. This case series reports on the acceptability and impact of an ACT-based multidisciplinary pain management programme on a range of health outcomes in both the short and long-term. METHODS: Seventy-three participants completed an 8-week group-based, pain management programme. The programme combined weekly sessions of ACT with education and exercise classes. Self-report outcome measures were completed at baseline, post-intervention and at one-year follow-up. The measures assessed pain intensity and interference, psychological distress, self-efficacy, pain acceptance, values-based action, pain catastrophizing, fear avoidance and healthcare utilization. Pedometers were worn to objectively measure physical activity. Data were analyzed using linear mixed modelling. Ethical approval for this study was granted by the Mater Misericordiae University Hospital (MMUH) Institutional Review Board (Reference 1/378/1541). RESULTS: Eighty-six percent of respondents reported being satisfied with the intervention. Improvements were observed in most of the self-report outcomes post-intervention and many changes were maintained at one-year. There was also a significant increase in average daily step-count. CONCLUSION: A pain management programme combining ACT with exercise appears to be an acceptable treatment option for people with chronic pain. While improvements were observed in both the short and long-term, further fully powered RCTs with long-term follow-up are required to test the effectiveness of this type of intervention.

Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial.

BACKGROUND: Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise. METHODS/DESIGN: This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit ZipTM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a purposeful sample of participants to explore patient experiences of both treatments. DISCUSSION: To our knowledge, this will be the first RCT to examine whether combining exercise with ACT produces greater benefit for patients with chronic pain, compared to a standalone supervised exercise programme. TRIAL REGISTRATION: www.ClinicalTrials.gov, ID: NCT03050528 . Registered on 13 February 2017.

Effects of anti-viral therapy and HCV clearance on cerebral metabolism and cognition.

BACKGROUND & AIMS: Chronic hepatitis C virus (HCV) infection is associated with altered cerebral metabolism and cognitive dysfunction. We aimed to evaluate the effect of pegylated interferon/ribavirin (PIFN/R) and HCV clearance on cerebral metabolism, and neuropsychological performance. METHODS: Fifteen non-cirrhotic HCV positive subjects underwent (1)H MR spectroscopy (MRS) before, during, and after treatment with PIFN/R. The metabolites of interest namely, N-acetylaspartate (NAA), choline (Cho), myo-inositol (MI), and the control metabolite creatine (Cr), were acquired from 3 different brain regions; left basal ganglia, left frontal cortex, and left dorso-lateral pre-frontal cortex. Coinciding with this, subjects also underwent a battery of neuropsychological tests to evaluate the domains of verbal learning, memory, attention, language, executive functioning, and motor skills. Seven HCV positive controls (not receiving anti-viral therapy) underwent MRS and neuropsychological testing at two time points, 12 weeks apart, to examine for variation in cerebral metabolites over time and the practice effect of repeat neuropsychological testing. RESULTS: Significant reductions in basal ganglia Cho/Cr (p=0.03) and basal ganglia MI/Cr (p=0.03) were observed in sustained virological responders (SVRs, n=8), but not non-responders/relapsers (NR/R, n=6), indicative of reduced cerebral infection and/or immune activation in those who cleared virus. SVRs demonstrated significant improvements in verbal learning, memory, and visuo-spatial memory. A small but significant improvement in neurocognitive function secondary to the practice effect was seen in both HCV controls and HCV subjects during treatment. CONCLUSIONS: HCV eradication has a beneficial effect on cerebral metabolism and selective aspects of neurocognitive function and is an important factor when contemplating anti-viral therapy in HCV, especially in those with mild disease.

Hepatitis C management: the challenge of dropout associated with male sex and injection drug use.

BACKGROUND: Anecdotal reports of poor patient compliance with hepatitis C disease management exist yet little data are available on the true rates of dropout. AIMS: To examine all referrals made to an urban tertiary care liver centre for hepatitis C virus (HCV) management, track subsequent progress and identify dropout trends. METHODS: A cross-sectional retrospective review was conducted to examine the HCV referrals received on 2000 through 2007. The demographic, clinical and treatment data were derived from medical charts and the hospital information system. RESULTS: A total of 588 individuals were referred for HCV disease management. The repeated referrals yielded 742 cases for analysis. Of the 742 referrals received, 141 (19%) failed to attend their initial appointment, 180 dropped out from early outpatient management, 29 failed to attend liver biopsy and 81 defected from subsequent outpatient follow-up. In total, 451 (61%) dropouts occurred. In those treated, a sustained viral response rate of 74% was observed (18/30 genotype 1; 4/5 genotype 2; 40/49 genotype 3). Statistically significant associations between history of injection drug use and dropout immediately after the referral (P<0.001), dropout from early outpatient management (P<0.001) and dropout over entire span of disease management (P<0.001) were observed. Male sex was also associated with dropout from disease management (P<0.05). CONCLUSIONS: An exceptionally high rate of dropout exists within the HCV disease management framework, particularly in the early stages of service delivery. Dropout was associated with sex and positive history of injection drug use. The study findings have led to the development of innovative approaches helping to optimize the disease management in this population. These developments are discussed.