Protocol for a feasibility and acceptability study using a brief ACT-based intervention for people from Southwest Wales who live with persistent pain.
ABSTRACT: INTRODUCTION:Persistent pain affects a large percentage of the UK population and its burden has wide ramifications that affect physical, psychological, socioeconomic and occupational status. Pain has a significant impact on people's well-being and quality of life. Some of the most common comorbidities found in this population are depression and anxiety and also maladaptive behaviours such as fear avoidance and catastrophising. METHODS AND ANALYSIS:This is a protocol for a study assessing the feasibility and acceptability of a novel Acceptance and Commitment Therapy (ACT)-based intervention for people from Southwest Wales who live with persistent pain. A group of 12 participants will be recruited through the Health and Wellbeing Academy (Swansea University). After being referred by an Osteopath, and attending a brief meeting with the researcher, the participants will take part in six sessions over six consecutive weeks. 'A Mindful Act' is an ACT-based group programme aiming to teach people how to develop more acceptance and self-compassion, be more mindful and clarify personal values in order to live a more rich and meaningful life. The main outcomes will include the feasibility of the recruitment process and the measurement tools, the acceptability of the intervention for both the participants and the Osteopaths and the adherence to the programme. In order to measure acceptability of the intervention, qualitative interviews will be conducted to provide an insight into peoples' experiences of taking part. Data will be analysed using Thematic Analysis, with the use of NVIVO 10. In addition, quantitative data will be collected at baseline, on completion of the programme and at 1?month and 3?months follow-up to reveal any differences in psychological flexibility, depression, anxiety, fear avoidance and general health status. The findings will help enhance the intervention by making appropriate modifications to the processes and procedures involved, following the recommendations made by the Medical Research Council framework. A larger scale study is envisaged to follow, in order to investigate the full effectiveness and cost-effectiveness of 'A Mindful Act'. ETHICS AND DISSEMINATION:This study was approved by the College of Human and Health Sciences Research Ethics Committee at Swansea University in December 2017. The findings will be disseminated through various means including: the first author's PhD thesis, peer-reviewed journals as well as well as national and international conferences and public events.
Project description:BACKGROUND:Exercise is often used in the treatment of chronic neck and shoulder muscle pain. It is likely that psychological aspects have an impact on the results of exercise-based treatments. OBJECTIVES:(1) To examine the associations between psychological factors and the effect of a home-based physical exercise intervention. (2) To examine differences in psychological factors at baseline between (a) subjects who continued in the trial and those who did not and (b) subjects who completed the intervention and those who did not. METHOD:A total of 57 women with chronic neck and shoulder pain were included in a home-based exercise intervention trial. Pain intensity, disability, and psychological factors (anxiety and depression symptoms, catastrophizing, fear-avoidance beliefs, self-efficacy, and pain acceptance) were measured at baseline, after 4-6?months, and after 1?year of exercise. Associations between the psychological factors and changes in pain intensity and disability were analysed, as well as differences in psychological factors at baseline between subjects who continued in and completed the intervention, and those who did not. RESULTS:Associations between positive changes in pain intensity and disability were found for low fear-avoidance beliefs and low-pain self-efficacy at baseline. In addition, fear-avoidance beliefs at baseline were higher in the subjects who dropped out of the intervention than in those who continued. Pain acceptance at baseline was higher in the subjects who completed the intervention at the end of the trial. CONCLUSION:Particularly, fear-avoidance beliefs and pain self-efficacy should be taken into consideration when implementing home-based physical exercise as treatment for chronic neck pain. In addition, high pain acceptance might improve the adherence to prescribed exercise.
Project description: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.
Project description:Objective: To evaluate feasibility and acceptability of a sub-threshold exercise program with minimal in-person visits to treat youth with persistent sport-related concussion, and explore efficacy for improving concussive symptoms, health-related quality of life, and fear-avoidance. Study design: We conducted a pilot randomized controlled trial comparing a 6 week sub-threshold exercise program requiring only two in-person visits to active control (stretching) for 12-18 year old youth with persistent sport-related concussion. We measured moderate-to-vigorous physical activity pre- and post-intervention using accelerometry, and increased goals weekly via phone contact. We examined feasibility and acceptability using qualitative interviews. We used exponential regression to model differences in trajectory of concussive symptoms by experimental group, and linear regression to model differences in trajectory of health-related quality of life and fear-avoidance of pain by experimental group. Results: Thirty-two subjects randomized, 30 completed the study (n = 11 control, n = 19 intervention), 57% female. Youth and parents reported enjoying participating in the study and appreciated the structure and support, as well as the minimal in-person visits. Exponential regression modeling indicated that concussive symptoms declined more rapidly in intervention youth than control (p = 0.02). Health-related quality of life and fear-avoidance of pain improved over time, but were not significantly different by group. Conclusions: This study indicates feasibility and potential benefit of a 6 week subthreshold exercise program with minimal in-person visits for youth with persistent concussion. Potential factors that may play a role in improvement such as fear-avoidance deserve further study.
Project description:Objective To conduct a single-arm pilot study assessing the feasibility and acceptability of a 30-day parent-focused mindfulness and psychosocial support mobile app intervention for parents of children with chronic pain. Methods Thirty parents completed the intervention, which included a mindfulness curriculum, peer support videos, and written psychoeducational content. Twelve healthcare providers also assessed the app and provided feedback. Feasibility was assessed by server-side documented usage on ?50% of the days in the intervention period and completion of ?70% of the mindfulness content. Parent and provider acceptance were assessed by ?70% of participants rating each acceptance test question as ?5 on a 7-point Likert scale. Parents completed measures of solicitousness, stress, mindful parenting, and resilience prior to and following the intervention. Results Feasibility results were mixed: parents completed mindfulness content on an average of 11.2?days during the intervention period, slightly under the pre-established criterion. However, parents completed an average of 72.1% of the content, which met feasibility criterion. Acceptance criteria were met for the majority of parent acceptance test questions and all of the provider acceptance test questions. Exploratory analyses of the psychosocial measures revealed significant decreases in parental solicitous behavior and perceived stress, and a significant increase in mindful parenting. Conclusions The current study extends the emerging body of research on mindfulness-based interventions for parents of children with chronic illness and suggests that it may be acceptable to deliver this content through a mobile device. Future research is needed to assess the intervention's efficacy compared to standard of care.
Project description:OBJECTIVES:To assess the feasibility and acceptability of a mindfulness-based stress reduction (MBSR)-based intervention and determine if the intervention is associated with a significant signal on empathy and emotional competencies. DESIGN:Two pre-post proof-of-concept studies. SETTING:Participants were recruited at the University of Montreal's Psychology Department (Study 1) and the CHU Sainte-Justine Department of Hematology-Oncology (Study 2). PARTICIPANTS:Study 1: 12 students completed the 8-week programme (mean age 24, range 18-34). Study 2: 25 professionals completed the 8-week programme (mean age 48, range 27-63). INTERVENTION:Standard MBSR programme including 8-week mindfulness programme consisting of 8 consecutive weekly 2-hour sessions and a full-day silent retreat. OUTCOMES MEASURES:Mindfulness as measured by the Mindful Attention Awareness Scale; empathy as measured by the Interpersonal Reactivity Index (IRI)'s Perspective Taking and Empathic Concern subscales; identification of one's own emotions and those of others as measured by the Profile of Emotional Competence (PEC)'s Identify my Emotions and Identify Others' Emotions subscales; emotional acceptance as measured by the Acceptance and Action Questionnaire-II (AAQ-II) and the Emotion Regulation Scale (ERQ)'s Expressive Suppression subscale; and recognition of emotions in others as measured by the Geneva Emotion Recognition Test (GERT). RESULTS:In both studies, retention rates (80%-81%) were acceptable. Participants who completed the programme improved on all measures except the PEC's Identify Others' Emotions and the IRI's Empathic Concern (Cohen's d median=0.92, range 45-1.72). In Study 2, favourable effects associated with the programme were maintained over 3 months on the PEC's Identify my Emotions, the AAQ-II, the ERQ's Expressive Suppression and the GERT. CONCLUSIONS:The programme was feasible and acceptable. It was associated with a significant signal on the following outcomes: perspective taking, the identification of one's own emotions and emotional acceptance, thus, justifying moving towards efficacy trials using these outcomes.
Project description:People with chronic musculoskeletal pain often experience pain-related fear of movement and avoidance behavior. The Fear-Avoidance model proposes a possible mechanism at least partly explaining the development and maintenance of chronic pain. People who interpret pain during movement as being potentially harmful to the organism may initiate a vicious behavioral cycle by generating pain-related fear of movement accompanied by avoidance behavior and hyper-vigilance.This study investigates whether an individually adapted multifactorial approach comprised of biopsychosocial elements, with a focus on physical exercise, mindfulness, and education on pain and behavior, can decrease work-related fear-avoidance beliefs.As part of a large scale 10-week worksite randomized controlled intervention trial focusing on company initiatives to combat work-related musculoskeletal pain and stress, we evaluated fear-avoidance behavior in 112 female laboratory technicians with chronic neck, shoulder, upper back, lower back, elbow, and hand/wrist pain using the Fear-Avoidance Beliefs Questionnaire at baseline, before group allocation, and again at the post intervention follow-up 10 weeks later.A significant group by time interaction was observed (P?<?0.05) for work-related fear-avoidance beliefs. The between-group difference at follow-up was -2.2 (-4.0 to -0.5), corresponding to a small to medium effect size (Cohen's d?=?0.30).Our study shows that work-related, but not leisure time activity-related, fear-avoidance beliefs, as assessed by the Fear-avoidance Beliefs Questionnaire, can be significantly reduced by 10 weeks of physical-cognitive-mindfulness training in female laboratory technicians with chronic pain.
Project description:INTRODUCTION:Recent studies have revealed a high prevalence of depression, anxiety and stress symptoms among university students, highlighting an urgent need for preventative measures at low cost to better support often overwhelmed support services. OBJECTIVE:Here we propose a protocol for assessing the feasibility of a randomised controlled trial (RCT) for an online transdiagnostic psychoeducational intervention called 'A Bite of ACT' compared with a waitlist control. METHODS AND ANALYSIS:This is an RCT with crossover design involving baseline assessments and two follow-up periods. The primary outcome measure will be the Acceptance Checklist for Clinical Effectiveness Pilot Trials (ACCEPT) for measuring the feasibility of the trial design and methods. Secondary outcomes include measures of well-being, social connectedness, quality of life (EuroQol Five Dimensions), depression, anxiety and stress (Depression Anxiety Stress Scales-21), as well as the process measures: psychological flexibility (Acceptance and Action Questionnaire-Second Version and the Mindful Attention Awareness Scale) and heart rate variability. Analysis will involve calculating descriptive statistics, examining trial feasibility outcomes through ACCEPT, and determining effect size measures to determine the sample size needed in a future trial (if indicated). Qualitative interviews and preliminary health economics analysis will provide additional insights into the feasibility of the intervention and trial methods. ETHICS AND DISSEMINATION:This study has been approved by the Department of Psychology Research Ethics Committee in the College of Human and Health Sciences at Swansea University. Dissemination will involve publication in international peer-reviewed journals, presentation of findings at relevant local, national and international conferences, and promotion of study outcomes using social media and other channels for disseminating findings to the wider community. TRIAL REGISTRATION NUMBER:NCT03810131; Pre-results.
Project description:OBJECTIVE:Apply the National Institutes of Health (NIH) Stage Model to design and test an intervention to prevent depression in breast cancer patients at risk for depression. METHODS:We identified mindful emotion awareness, along with approach and avoidance strategies for cancer-related coping and emotion regulation, as targets for a preventive intervention adapted from the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Patients' preferences for individual, in-person, and time-efficient sessions informed the design. Patients at risk for depression received a 6-week, 5-hour intervention with daily exercises. Intervention targets were assessed at baseline, before each session, and 4-weeks post intervention. Mixed effects analysis of variance (ANOVA) assessed change over the follow-up period, controlling for age, partnered status, and disease stage. RESULTS:Fifty-five percent (40/72) of women screened within 6 months of diagnosis had elevated depression risk. Of these, 24 (60%) signed consent. Sixteen received intervention after five were excluded for current depressive disorder, cognitive impairment, or death. Three dropped out. Ninety-eight percent attendance and 77% practice days indicated feasibility. Effect sizes (Cohen's d) corrected for regression to the mean (RTM) were 0.82 for cancer-related acceptance coping, 0.65 for cancer-related emotional expression, and 0.32 and 0.42 for decreased cancer-related avoidance coping and depressive symptoms, respectively. Effect sizes for variables lacking data to correct for RTM were 1.0, 0.7, and 0.5 for decreased rumination, experiential avoidance, and fear of depression, respectively, and 1.3, 0.6, and 0.4 for increased cognitive flexibility, distress tolerance, and describing/not judging emotions, respectively. CONCLUSIONS:The feasibility of this intervention and malleability of its targets support its further investigation.
Project description:Mindfulness training ameliorates clinical and self-report measures of depression and chronic pain, but its use as an emotion regulation strategy-in individuals who do not meditate-remains understudied. As such, whether it (i) down-regulates early affective brain processes or (ii) depends on cognitive control systems remains unclear. We exposed meditation-naïve participants to two kinds of stimuli: negative vs. neutral images and painful vs. warm temperatures. On alternating blocks, we asked participants to either react naturally or exercise mindful acceptance. Emotion regulation using mindful acceptance was associated with reductions in reported pain and negative affect, reduced amygdala responses to negative images and reduced heat-evoked responses in medial and lateral pain systems. Critically, mindful acceptance significantly reduced activity in a distributed, a priori neurologic signature that is sensitive and specific to experimentally induced pain. In addition, these changes occurred in the absence of detectable increases in prefrontal control systems. The findings support the idea that momentary mindful acceptance regulates emotional intensity by changing initial appraisals of the affective significance of stimuli, which has consequences for clinical treatment of pain and emotion.