A randomised controlled trial of acceptance and commitment therapy plus usual care compared to usual care alone for improving psychological health in people with motor neuron disease (COMMEND): study protocol
Tóm tắt
Motor neuron disease (MND) is a rapidly progressive, fatal neurodegenerative disease that predominantly affects motor neurons from the motor cortex to the spinal cord and causes progressive wasting and weakening of bulbar, limb, abdominal and thoracic muscles. Prognosis is poor and median survival is 2–3 years following symptom onset. Psychological distress is relatively common in people living with MND. However, formal psychotherapy is not routinely part of standard care within MND Care Centres/clinics in the UK, and clear evidence-based guidance on improving the psychological health of people living with MND is lacking. Previous research suggests that Acceptance and Commitment Therapy (ACT) may be particularly suitable for people living with MND and may help improve their psychological health. To assess the clinical and cost-effectiveness of ACT modified for MND plus usual multidisciplinary care (UC) in comparison to UC alone for improving psychological health in people living with MND. The COMMEND trial is a multi-centre, assessor-blind, parallel, two-arm RCT with a 10-month internal pilot phase. 188 individuals aged ≥ 18 years with a diagnosis of definite, laboratory-supported probable, clinically probable, or possible familial or sporadic amyotrophic lateral sclerosis, and additionally the progressive muscular atrophy and primary lateral sclerosis variants, will be recruited from approximately 14 UK-based MND Care Centres/clinics and via self-referral. Participants will be randomly allocated to receive up to eight 1:1 sessions of ACT plus UC or UC alone by an online randomisation system. Participants will complete outcome measures at baseline and at 6- and 9-months post-randomisation. The primary outcome will be quality of life at six months. Secondary outcomes will include depression, anxiety, psychological flexibility, health-related quality of life, adverse events, ALS functioning, survival at nine months, satisfaction with therapy, resource use and quality-adjusted life years. Primary analyses will be by intention to treat and data will be analysed using multi-level modelling. This trial will provide definitive evidence on the clinical and cost-effectiveness of ACT plus UC in comparison to UC alone for improving psychological health in people living with MND. ISRCTN Registry, ISRCTN12655391. Registered 17 July 2017,
https://www.isrctn.com/ISRCTN12655391
. Protocol version: 3.1 (10/06/2020).
Tài liệu tham khảo
Al-Chalabi A, Hardiman O. The epidemiology of ALS: a conspiracy of genes, environment and time. Nat Rev Neurol. 2013;9(11):617–28.
Chiò A, Logroscino G, Hardiman O, Swingler R, Mitchell D, Beghi E, et al. Prognostic factors in ALS: a critical review. Amyotroph Lateral Scler. 2009;10(5–6):310–23.
Turner MR, Parton MJ, Shaw CE, Leigh PN, Al-Chalabi A. Prolonged survival in motor neuron disease: a descriptive study of the King’s database 1990–2002. J Neurol Neurosurg Psychiatry. 2003;74(7):995–7.
Miller RG, Mitchell JD, Moore DH. Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev. 2012;2012(3):CD001447.
Averill AJ, Kasarskis EJ, Segerstrom SC. Psychological health in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler. 2007;8(4):243–54.
Kurt A, Nijboer F, Matuz T, Kübler A. Depression and anxiety in individuals with amyotrophic lateral sclerosis: epidemiology and management. CNS Drugs. 2007;21(4):279–91.
Taylor L, Wicks P, Leigh PN, Goldstein LH. Prevalence of depression in amyotrophic lateral sclerosis and other motor disorders. Eur J Neurol. 2010;17(8):1047–53.
Fang F, Valdimarsdóttir U, Fürst CJ, Hultman C, Fall K, Sparén P, et al. Suicide among patients with amyotrophic lateral sclerosis. Brain. 2008;131(10):2729–33.
McDonald ER, Wiedenfeld SA, Hillel A, Carpenter CL, Walter RA. Survival in amyotrophic lateral sclerosis. The role of psychological factors. Arch Neurol. 1994;51(1):17–23.
Johnston M, Earll L, Giles M, Mcclenahan R, Stevens D, Morrison V. Mood as a predictor of disability and survival in patients newly diagnosed with ALS/MND. Br J Health Psychol. 1999;4(2):127–36.
Pizzimenti A, Aragona M, Onesti E, Inghilleri M. Depression, pain and quality of life in patients with amyotrophic lateral sclerosis: a cross-sectional study. Funct Neurol. 2013;28(2):115–9.
van Groenestijn AC, Kruitwagen-van Reenen ET, Visser-Meily JMA, van den Berg LH, Schröder CD. Associations between psychological factors and health-related quality of life and global quality of life in patients with ALS: a systematic review. Health Qual Life Outcomes. 2016;14(1):107.
National Institute for Health and Care Excellence. Motor neurone disease: Assessment and management (NG42) [Internet]. 2016. Available from: www.nice.org.uk/Guidance/NG42.
National Institute for Health Care Excellence. Common mental health problems: Identification and pathways to care (CG123). 2016.
Weeks KR, Gould RL, Mcdermott C, Lynch J, Goldstein LH, Graham CD, et al. Needs and preferences for psychological interventions of people with motor neuron disease. Amyotroph Lateral Scler Front Degener. 2019;20(7–8):521–31.
Hayes S, Strosahl K, Wilson K. Acceptance and Commitment Therapy: The process and practice of mindful change. 2nd ed. New York: Guilford Press; 2012.
McCracken LM, Yu L, Vowles KE. New generation psychological treatments in chronic pain. BMJ. 2022;28: e057212.
Gloster AT, Walder N, Levin ME, Twohig MP, Karekla M. The empirical status of acceptance and commitment therapy: a review of meta-analyses. J Context Behav Sci. 2020;18:181–92.
Hayes SC, Strosahl K, Wilson KG, Bissett RT, Pistorello J, Toarmino D, et al. Measuring experiential avoidance: a preliminary test of a working model. Psychol Rec. 2004;54(4):553–78.
Kangas M, McDonald S. Is it time to act? The potential of acceptance and commitment therapy for psychological problems following acquired brain injury. Neuropsychol Rehabil. 2011;21(2):250–76.
Graham CD, Simmons Z, Stuart SR, Rose MR. The potential of psychological interventions to improve quality of life and mood in muscle disorders. Muscle Nerve. 2015;52(1):131–6.
Serfaty M. The addition of ACT or a Talking Control to treatment as usual for the management of dysfunction in advanced cancer: a feasibility randomised controlled trial (CanACT).
Hadlandsmyth K, White KS, Nesin AE, Greco LA. Proposing an acceptance and commitment therapy intervention to promote improved diabetes management in adolescents: a treatment conceptualization. Int J Behav Consult Ther. 2013;7(4):12–5.
McCracken LM, Vowles KE. Acceptance and commitment therapy and mindfulness for chronic pain: model, process, and progress. Am Psychol. 2014;69(2):178–87.
Pagnini F, Phillips D, Bosma CM, Reece A, Langer E, Langer E. Mindfulness, physical impairment and psychological well-being in people with amyotrophic lateral sclerosis. Psychol Health. 2015;30(5):503–17.
Graham C. Explaining and changing adverse illness perceptions in people with muscle disease. Kings College London; 2012.
Graham CD, Rose MR, Hankins M, Chalder T, Weinman J. Separating emotions from consequences in muscle disease: Comparing beneficial and unhelpful illness schemata to inform intervention development. J Psychosom Res. 2013;74(4):320–6.
Graham CD, Gouick J, Ferreira N, Gillanders D. The influence of psychological flexibility on life satisfaction and mood in muscle disorders. Rehabil Psychol. 2016;61(2):210–7.
Graham CD, Rose MR. What explains high life satisfaction in men living with Duchenne muscular dystrophy? A preliminary study to inform psychological intervention. Muscle Nerve. 2017;56(1):163–6.
Low J, Davis S, Drake R, King M, Tookman A, Turner K, et al. The role of acceptance in rehabilitation in life-threatening illness. J Pain Symptom Manage. 2012;43(1):20–8.
Pakenham KI, Fleming M. Relations between acceptance of multiple sclerosis and positive and negative adjustments. Psychol Health. 2011;26(10):1292–309.
Veehof MM, Trompetter HR, Bohlmeijer ET, Schreurs KMG. Acceptance- and mindfulness-based interventions for the treatment of chronic pain: a meta-analytic review. Cogn Behav Ther. 2016;45(1):5–31.
Clarke S, Kingston J, James K, Bolderston H, Remington B. Acceptance and commitment therapy group for treatment-resistant participants: a randomized controlled trial. J Context Behav Sci. 2014;3(3):179–88.
Wetherell JL, Liu L, Patterson TL, Afari N, Ayers CR, Thorp SR, et al. Acceptance and commitment therapy for generalized anxiety disorder in older adults: a preliminary report. Behav Ther. 2011;42(1):127–34.
Gould RL, Rawlinson C, Thompson B, Weeks K, Gossage-Worrall R, Cantrill H, et al. Acceptance and Commitment Therapy for people living with motor neuron disease: A feasibility study. submitted;
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ [Internet]. 2014 Mar 7 [cited 2020 Jul 14];348. Available from: https://www.bmj.com/content/348/bmj.g1687.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200.
Al-Chalabi A, Hardiman O, Kiernan MC, Chiò A, Rix-Brooks B, van den Berg LH. Amyotrophic lateral sclerosis: moving towards a new classification system. Lancet Neurol. 2016;15(11):1182–94.
Brooks BR, Miller RG, Swash M, Munsat TL, World Federation of Neurology Research Group on Motor Neuron Diseases. El Escorial revisited: revised criteria for the diagnosis of amyotrophic lateral sclerosis. Amyotroph Lateral Scler Mot Neuron Disord Off Publ World Fed Neurol Res Group Mot Neuron Dis. 2000 Dec;1(5):293–9.
Strong MJ, Abrahams S, Goldstein LH, Woolley S, Mclaughlin P, Snowden J, et al. Amyotrophic lateral sclerosis - frontotemporal spectrum disorder (ALS-FTSD): Revised diagnostic criteria. Amyotroph Lateral Scler Front Degener. 2017;18(3–4):153–74.
McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR, Kawas CH, et al. The diagnosis of dementia due to Alzheimer’s disease: Recommendations from the National Institute on Aging-Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement. 2011;7(3):263–9.
Beecham J, Knapp M. Costing psychiatric interventions. In: Measuring Mental Health Needs. London: Gaskell; 1992.
Plumb JC, Vilardaga R. Assessing treatment integrity in acceptance and commitment therapy: Strategies and suggestions. Int J Behav Consult Ther. 2010;6(3):263–95.
Nezu A, Nezu C. Evidence-based outcome research: A practical guide to conducting randomized controlled trials for psychosocial interventions. New York: Oxford University Press; 2008.
Cohen SR, Sawatzky R, Russell LB, Shahidi J, Heyland DK, Gadermann AM. Measuring the quality of life of people at the end of life: The McGill Quality of Life Questionnaire-Revised. Palliat Med. 2017;31(2):120–9.
Gagnon P, Fillion L, Robitaille MA, Girard M, Tardif F, Cochrane JP, et al. A cognitive–existential intervention to improve existential and global quality of life in cancer patients: A pilot study. Palliat Support Care. 2015;13(04):981–90.
Cohen SR, Mount BM. Living with cancer: ?Good? days and ?bad? days?What produces them? Cancer. 2000;89(8):1854–65.
Burns TM, Graham CD, Rose MR, Simmons Z. Quality of life and measures of quality of life in patients with neuromuscular disorders. Muscle Nerve. 2012;46(1):9–25.
Simmons Z, Bremer BA, Robbins RA, Walsh SM, Fischer S. Quality of life in ALS depends on factors other than strength and physical function. Neurology. 2000;55(3):388–92.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.
Gibbons CJ, Mills RJ, Thornton EW, Ealing J, Mitchell JD, Shaw PJ, et al. Rasch analysis of the hospital anxiety and depression scale (hads) for use in motor neurone disease. Health Qual Life Outcomes. 2011;9(1):82.
Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al. Preliminary Psychometric Properties of the Acceptance and Action Questionnaire–II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011;42(4):676–88.
Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.
Cedarbaum JM, Stambler N, Malta E, Fuller C, Hilt D, Thurmond B, et al. The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory function. BDNF ALS Study Group (Phase III). J Neurol Sci. 1999 Oct;169(1–2):13–21.
Oei TPS, Green AL. The Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) for group psychotherapy: Psychometric properties and confirmatory factor analysis. Prof Psychol Res Pract. 2008;39(4):435–42.
Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980;20(6):649–55.
Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000;31(2):73–86.
Twohig MP, Hayes SC, Plumb JC, Pruitt LD, Collins AB, Hazlett-Stevens H, et al. A randomized clinical trial of acceptance and commitment therapy versus progressive relaxation training for obsessive-compulsive disorder. J Consult Clin Psychol. 2010;78(5):705–16.
Lenglet T, Lacomblez L, Abitbol JL, Ludolph A, Mora JS, Robberecht W, et al. A phase II−III trial of olesoxime in subjects with amyotrophic lateral sclerosis. Eur J Neurol. 2014;21(3):529–36.
Kuyken W, Byford S, Byng R, Dalgleish T, Lewis G, Taylor R, et al. Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial. Trials. 2010;11(1):99.
A-Tjak JGL, Davis ML, Morina N, Powers MB, Smits JAJ, Emmelkamp PMG. A Meta-Analysis of the Efficacy of Acceptance and Commitment Therapy for Clinically Relevant Mental and Physical Health Problems. Psychother Psychosom. 2015;84(1):30–6.
Graham CD, Gouick J, Krahé C, Gillanders D. A systematic review of the use of Acceptance and Commitment Therapy (ACT) in chronic disease and long-term conditions. Clin Psychol Rev. 2016;46:46–58.
Norman GR, Sloan JA, Wyrwich KW. Interpretation of Changes in Health-related Quality of Life. Med Care. 2003;41(5):582–92.
Little R, Rubin D. Statistical Analysis with Missing Data (2nd edition). New Jersey: Wiley; 2002.
Little RJ, Long Q, Lin X. A Comparison of methods for estimating the causal effect of a treatment in randomized clinical trials subject to noncompliance. Biometrics. 2009;65(2):640–9.
Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.
Department of Health. NHS reference costs 2014/2015. 2015.
Curtis L, Burns A. Unit costs of health and social care 2015. Personal Social Services Research Unit: University of Kent; 2015.
Musson LS, Collins A, Opie-Martin S, Bredin A, Hobson EV, Barkhouse E, et al. Impact of the covid-19 pandemic on amyotrophic lateral sclerosis care in the UK. Amyotroph Lateral Scler Front Degener. 2022;22:1–9.