Attachment-based compassion therapy and adapted mindfulness-based stress reduction for the treatment of depressive, anxious and adjustment disorders in mental health settings: a randomised controlled clinical trial protocol

Jesus Montero-Marin, Carlos Collado-Navarro, Mayte Navarro-Gil, Alba Lopez-Montoyo, Marcelo Demarzo, Paola Herrera-Mercadal, Alberto Barcelo-Soler, Javier Garcia-Campayo, Jesus Montero-Marin, Carlos Collado-Navarro, Mayte Navarro-Gil, Alba Lopez-Montoyo, Marcelo Demarzo, Paola Herrera-Mercadal, Alberto Barcelo-Soler, Javier Garcia-Campayo

Abstract

Introduction: Depressive, anxiety and adjustment disorders are highly prevalent among mental health outpatients. The lack of funding for mental health problems produces inefficient results and a high burden of disease. New cost-effective group interventions aimed at treating these symptoms might be an appropriate solution to reduce the healthcare burden in mental health units. Mindfulness-based interventions (MBIs) have shown significant reductions in anxious, depressive and adjustment symptomatology. Recent research highlights the influence of compassion as a key mechanism of change. However, MBIs only address compassion implicitly, whereas compassion-based protocols consider it a core aspect of psychotherapy. In this randomised controlled trial, we hypothesise that the provision of attachment-based compassion therapy (ABCT), which is a compassion-based protocol, will be more effective than mindfulness-based stress reduction (MBSR), which is a conventional MBI programme, for the treatment of depressive, anxious and adaptive symptoms in patients in mental health settings.

Methods and analysis: Approximately 90 patients suffering from depressive, anxious or adjustment disorders recruited from Spanish mental health settings will be randomised to receive 8 weekly 2 hours group sessions of ABCT, 8 weekly 2.5 hours group sessions of adapted MBSR (with no full-day silent retreat) or treatment as usual (TAU), with a 1:1:1 allocation rate. Patients in the ABCT and adapted MBSR groups will also receive TAU. The main outcome will be general affective distress measured by means of the 'Depression Anxiety Stress Scales-21' at post-test as primary endpoint. Other outcomes will be quality of life, mindfulness, self-compassion and the use of healthcare services. There will be a 6-month follow-up assessment. Intention-to-treat analysis will be conducted using linear mixed models. Per-protocol and secondary outcome analyses will be performed. A data monitoring committee comprising the trial manager, the ABCT and MBSR teachers and an independent clinical psychologist will monitor for possible negative side effects.

Ethics and dissemination: Approval was obtained from the Ethics Committee of the General University Hospital of Castellón, Spain. The results will be submitted to peer-reviewed specialised journals, and brief reports will be sent to participants on request.

Trial registration number: NCT03425487.

Keywords: ABCT; MBSR; RCT; adjustment; anxiety; depression.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Partcipant timeline. TAU, treatment as usual.
Figure 2
Figure 2
Study flow.

References

    1. Richards D. Prevalence and clinical course of depression: a review. Clin Psychol Rev 2011;31:1117–25. 10.1016/j.cpr.2011.07.004
    1. GBD 2015 Disease and Injury Incidence and Prevalence Collaborators Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the global burden of disease study 2015. Lancet 2016;388:1545–602. 10.1016/S0140-6736(16)31678-6
    1. World Health Organization Depression and other common mental disorders: global health estimates. World Heal Organ, 2017: 1–24.
    1. Kuo DC, Tran M, Shah AA, et al. . Depression and the suicidal patient. Emerg Med Clin North Am 2015;33:765–78. 10.1016/j.emc.2015.07.005
    1. Wang J, Wu X, Lai W, et al. . Prevalence of depression and depressive symptoms among outpatients: a systematic review and meta-analysis. BMJ Open 2017;7:e017173 10.1136/bmjopen-2017-017173
    1. American Psychiatric Association Diagnostic and statistical manual of mental disorders. 5th edn Washington DC: Author, 2013.
    1. Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci 2015;17:327–35.
    1. Bandelow B, Reitt M, Röver C, et al. . Efficacy of treatments for anxiety disorders: a meta-analysis. Int Clin Psychopharmacol 2015;30:183–92. 10.1097/YIC.0000000000000078
    1. Kessler RC, Berglund P, Demler O, et al. . The epidemiology of major depressive disorder: results from the National comorbidity survey replication (NCS-R). JAMA 2003;289:3095–105.
    1. Schoevers RA, Deeg DJH, van Tilburg W, et al. . Depression and generalized anxiety disorder: co-occurrence and longitudinal patterns in elderly patients. The American Journal of Geriatric Psychiatry 2005;13:31–9. 10.1097/00019442-200501000-00006
    1. Kessler RC, Merikangas KR, Wang PS. Prevalence, comorbidity, and service utilization for mood disorders in the United States at the beginning of the twenty-first century. Annu Rev Clin Psychol 2007;3:137–58. 10.1146/annurev.clinpsy.3.022806.091444
    1. Carter RM, Wittchen H-U, Pfister H, et al. . One-Year prevalence of subthreshold and threshold DSM-IV generalized anxiety disorder in a nationally representative sample. Depress Anxiety 2001;13:78–88. 10.1002/da.1020
    1. Maercker A, Lorenz L. Adjustment disorder diagnosis: improving clinical utility. The World Journal of Biological Psychiatry 2018;19:S3–S13. 10.1080/15622975.2018.1449967
    1. Bachem R, Casey P. Adjustment disorder: a diagnosis whose time has come. J Affect Disord 2018;227:243–53. 10.1016/j.jad.2017.10.034
    1. Reed GM, CORREIA JM, Esparza P, et al. . The WPA-WHO global survey of psychiatrists’ attitudes towards mental disorders classification. World Psychiatry 2011;10:118–31. 10.1002/j.2051-5545.2011.tb00034.x
    1. Evans SC, Reed GM, Roberts MC, et al. . Psychologists' perspectives on the diagnostic classification of mental disorders: results from the WHO-IUPsyS global survey. Int J Psychol 2013;48:177–93. 10.1080/00207594.2013.804189
    1. Casey P, Maracy M, Kelly BD, et al. . Can adjustment disorder and depressive episode be distinguished? results from Odin. J Affect Disord 2006;92:291–7. 10.1016/j.jad.2006.01.021
    1. Ventevogel P, Pérez-Sales P, Férnandez-Liria A, et al. . Integrating mental health care into existing systems of health care: during and after complex humanitarian emergencies. Interv Int J Ment Heal Psychosoc Work Couns Areas Armed Confl 2011;9:195–210.
    1. Sundquist J, Ohlsson H, Sundquist K, et al. . Common adult psychiatric disorders in Swedish primary care where most mental health patients are treated. BMC Psychiatry 2017;17:235 10.1186/s12888-017-1381-4
    1. Baumeister H, Maercker A, Casey P. Adjustment disorder with depressed mood: a critique of its DSM-IV and ICD-10 conceptualisations and recommendations for the future. Psychopathology 2009;42:139–47.
    1. Servant D, Pelissolo A, Chancharme L, et al. . Adjustment disorders with anxiety. Clinical and psychometric characteristics in patients consulting a general practitioner. Encephale 2013;39:347–51.
    1. Casey P, Jabbar F, O’Leary E, et al. . Suicidal behaviours in adjustment disorder and depressive episode. J Affect Disord 2015;174:441–6. 10.1016/j.jad.2014.12.003
    1. Fernández A, Haro JM, Codony M, et al. . Treatment adequacy of anxiety and depressive disorders: primary versus specialised care in Spain. J Affect Disord 2006;96:9–20. 10.1016/j.jad.2006.05.005
    1. Harris MG, Hobbs MJ, Burgess PM, et al. . Frequency and quality of mental health treatment for affective and anxiety disorders among Australian adults. Med J Aust 2015;202:185–9. 10.5694/mja14.00297
    1. Kladnitski N, Smith J, Allen A, et al. . Online mindfulness-enhanced cognitive behavioural therapy for anxiety and depression: outcomes of a pilot trial. Internet Interventions 2018;13:41–50. 10.1016/j.invent.2018.06.003
    1. Huhn M, Tardy M, Spineli LM, et al. . Efficacy of pharmacotherapy and psychotherapy for adult psychiatric disorders: a systematic overview of meta-analyses. JAMA Psychiatry 2014;71:706–15.
    1. Cuijpers P, Gentili C, Baños RM, et al. . Relative effects of cognitive and behavioral therapies on generalized anxiety disorder, social anxiety disorder and panic disorder: a meta-analysis. J Anxiety Disord 2016;43:79–89. 10.1016/j.janxdis.2016.09.003
    1. Sundquist J, Lilja Åsa, Palmér K, et al. . Mindfulness group therapy in primary care patients with depression, anxiety and stress and adjustment disorders: randomised controlled trial. Br J Psychiatry 2015;206:128–35. 10.1192/bjp.bp.114.150243
    1. Hayes SC, Villatte M, Levin M, et al. . Open, aware, and active: contextual approaches as an emerging trend in the behavioral and cognitive therapies. Annu Rev Clin Psychol 2011;7:141–68. 10.1146/annurev-clinpsy-032210-104449
    1. Lutz A, Jha AP, Dunne JD, et al. . Investigating the phenomenological matrix of mindfulness-related practices from a neurocognitive perspective. American Psychologist 2015;70:632–58. 10.1037/a0039585
    1. Kabat-Zinn J. University of Massachusetts medical Center/Worcester. stress reduction clinic. full catastrophe living: using the wisdom of your body and mind to face stress, pain, and illness. New York: Bantam Books, 1991.
    1. Segal ZV, Williams JMG, Teasdale JD. Mindfulness-based cognitive therapy for depression: a new approach to preventing relapse. New York: Guilford Press, 2002.
    1. Schückher F, Nilsson K. Moderately strong support for mindfulness-based therapies. A literature review of treatment outcome in stress, depression and anxiety. Lakartidningen 2011;108:2020–3.
    1. Gotink RA, Chu P, Busschbach JJV, et al. . Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One 2015;10:e0124344–17. 10.1371/journal.pone.0124344
    1. Khoury B, Lecomte T, Fortin G, et al. . Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev 2013;33:763–71. 10.1016/j.cpr.2013.05.005
    1. Wang Y-Y, Li X-H, Zheng W, et al. . Mindfulness-based interventions for major depressive disorder: a comprehensive meta-analysis of randomized controlled trials. J Affect Disord 2018;229:429–36. 10.1016/j.jad.2017.12.093
    1. Williams C, Mercer S. Can mindfulness groups treat common mental health problems? problematic design and short follow-up fails to answer the question. Evid Based Ment Health 2015;18:124 10.1136/eb-2015-102108
    1. Linardon J, Fairburn CG, Fitzsimmons-Craft EE, et al. . The empirical status of the third-wave behaviour therapies for the treatment of eating disorders: a systematic review. Clin Psychol Rev 2017;58:125–40. 10.1016/j.cpr.2017.10.005
    1. Feldman C, Kuyken W. Compassion in the landscape of suffering. Contemporary Buddhism 2011;12:143–55. 10.1080/14639947.2011.564831
    1. MacBeth A, Gumley A. Exploring compassion: a meta-analysis of the association between self-compassion and psychopathology. Clin Psychol Rev 2012;32:545–52. 10.1016/j.cpr.2012.06.003
    1. Montero-Marin J, Kuyken W, Crane C, et al. . Self-Compassion and cultural values: a cross-cultural study of Self-Compassion using a Multitrait-Multimethod (MTMM) analytical procedure. Front Psychol 2018;9:2638 10.3389/fpsyg.2018.02638
    1. Germer CK, Neff KD. Self-Compassion in clinical practice. J Clin Psychol 2013;69:856–67. 10.1002/jclp.22021
    1. Gu J, Strauss C, Bond R, et al. . How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev 2015;37:1–12. 10.1016/j.cpr.2015.01.006
    1. Hollis-Walker L, Colosimo K, Mindfulness CK. Mindfulness, self-compassion, and happiness in non-meditators: a theoretical and empirical examination. Pers Individ Dif 2011;50:222–7. 10.1016/j.paid.2010.09.033
    1. Neff KD, Germer CK. A pilot study and randomized controlled trial of the mindful Self-Compassion program. J Clin Psychol 2013;69:28–44. 10.1002/jclp.21923
    1. Gilbert P, Procter S. Compassionate mind training for people with high shame and self-criticism: overview and pilot study of a group therapy approach. Clin Psychol Psychother 2006;13:353–79. 10.1002/cpp.507
    1. García-Campayo J, Demarzo M. Mindfulness Y compasión: La nueva revolución. Siglantana: Barcelona, 2015.
    1. García-Campayo J, Navarro-Gil M, Demarzo M. Attachment-based compassion therapy. Mindfulness & Compassion 2016;1:68–74. 10.1016/j.mincom.2016.10.004
    1. Navarro-Gil M, Lopez-del-Hoyo Y, Modrego-Alarcón M, et al. . Effects of Attachment-Based compassion therapy (ABCT) on Self-compassion and attachment style in healthy people. Mindfulness 2018;13 10.1007/s12671-018-0896-1
    1. Homan KJ, Sirois FM. Self-compassion and physical health: exploring the roles of perceived stress and health-promoting behaviors. Health Psychology Open 2017;4 10.1177/2055102917729542
    1. Montero-Marín J, Navarro-Gil M, Puebla-Guedea M, et al. . Efficacy of “attachment-based compassion therapy” in the treatment of fibromyalgia: A randomized controlled trial. Front. Psychiatry 2018;8 10.3389/fpsyt.2017.00307
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c869 10.1136/bmj.c869
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. First MB, Williams JBW, Karg RS, et al. . Structured clinical interview for DSM-5—Research version (SCID-5 for DSM-5, research version; SCID-5-RV). Arlington, Va, American psychiatric association 2015.
    1. Craig P, Dieppe P, Macintyre S, et al. . Developing and evaluating complex interventions: new guidance. UK: Medical Research Council, 2008.
    1. Fearon RMP, Roisman GI. Attachment theory: progress and future directions. Current Opinion in Psychology 2017;15:131–6. 10.1016/j.copsyc.2017.03.002
    1. Santorelli SF, Meleo-Meyers F, Koerbel L. Mindfulness-Based stress reduction (MBSR) authorized curriculum guide. United States, Boston: center for mindfulness in medicine, health care, and Society (CFM) University of Massachusetts medical school, 2017.
    1. Segal Z, Williams M, Teasdale J. Mindulness-based cognitive therapy for depression: a new approach to preventing relapse. New York, NY: Guilford Press, 2002.
    1. Samuelson M, Carmody J, Kabat-Zinn J, et al. . Mindfulness-Based stress reduction in Massachusetts correctional facilities. Prison J 2007;87:254–68. 10.1177/0032885507303753
    1. Dobkin PL, Hickman S, Monshat K. Holding the heart of Mindfulness-Based stress reduction: balancing fidelity and imagination when adapting MBSR. Mindfulness 2014;5:710–8. 10.1007/s12671-013-0225-7
    1. Clark LA, Watson D. Tripartite model of anxiety and depression: psychometric evidence and taxonomic implications. J Abnorm Psychol 1991;100:316–36. 10.1037/0021-843X.100.3.316
    1. Lovibond SH, Lovibond PF. Manual for the depression anxiety stress scales. 2nd edn Sydney N.S.W: Psychology Foundation of Australia, 1995.
    1. Daza P, Novy DM, Stanley MA, et al. . The depression anxiety stress Scale-21: Spanish translation and validation with a Hispanic sample. J Psychopathol Behav Assess 2002;24:195–205. 10.1023/A:1016014818163
    1. EuroQol Group EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199–208. 10.1016/0168-8510(90)90421-9
    1. Badia X, Roset M, Montserrat S, et al. . The Spanish version of EuroQol: a description and its applications. European quality of life scale. Med Clin 1999;112:79–85.
    1. Baer RA, Smith GT, Hopkins J, et al. . Using self-report assessment methods to explore facets of mindfulness. Assessment 2006;13:27–45. 10.1177/1073191105283504
    1. Neff KD. The development and validation of a scale to measure self-compassion. Self and Identity 2003;2:223–50. 10.1080/15298860309027
    1. Cebolla A, García-Palacios A, Soler J, et al. . Psychometric properties of the Spanish validation of the five facets of mindfulness questionnaire (FFMQ). Eur. J. Psychiat. 2012;26:118–26. 10.4321/S0213-61632012000200005
    1. Neff KD, Tóth-Király I, Yarnell LM, et al. . Examining the factor structure of the Self-Compassion scale in 20 diverse samples: support for use of a total score and six subscale scores. Psychol Assess 2018;31:27–45. 10.1037/pas0000629
    1. Garcia-Campayo J, Navarro-Gil M, Andrés E, et al. . Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the Self-Compassion scale (scs). Health Qual Life Outcomes 2014;12:4 10.1186/1477-7525-12-4
    1. Beecham JK, Knapp MRJ. Costing psychiatric interventions : Thornicroft G, Measuring mental health needs. London: Royal Collegues of Psychiatrists, 2001: 200–24.
    1. Vazquez-Barquero JL, Gaite L, Cuesta MJ, et al. . Spanish version of the CSRI: a mental health cost evaluation interview. Arch Neurobiol 1997;60:171–84.
    1. Strauss C, Cavanagh K, Oliver A, et al. . Mindfulness-based interventions for people diagnosed with a current episode of an anxiety or depressive disorder: a meta-analysis of randomised controlled trials. PLoS One 2014;9:e96110 10.1371/journal.pone.0096110
    1. Boutron I, Moher D, Altman DG, et al. . Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008;148:295–309. 10.7326/0003-4819-148-4-200802190-00008
    1. Moher D, Hopewell S, Schulz KF, et al. . Consort 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. International Journal of Surgery 2012;10:28–55. 10.1016/j.ijsu.2011.10.001
    1. Egbewale BE, Lewis M, Sim J. Bias, precision and statistical power of analysis of covariance in the analysis of randomized trials with baseline imbalance: a simulation study. BMC Med Res Methodol 2014;14:49 10.1186/1471-2288-14-49
    1. Morris SB. Estimating effect sizes from Pretest-Posttest-Control group designs. Organizational Research Methods 2008;11:364–86. 10.1177/1094428106291059
    1. Cohen J. Statistical power analysis for the behavioral sciences (2. Auflage. Hillsdale, NJ: Erlbaum, 1998.
    1. Nakagawa S, Johnson PCD, Schielzeth H. The coefficient of determination R2 and intra-class correlation coefficient from generalized linear mixed-effects models revisited and expanded. J R Soc Interface 2017;14. doi:10.1098/rsif.2017.0213
    1. Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol 1991;59:12–19. 10.1037/0022-006X.59.1.12
    1. White IR, Royston P, Wood AM. Multiple imputation using chained equations: issues and guidance for practice. Stat Med 2011;30:377–99. 10.1002/sim.4067
    1. Kuyken W, Byford S, Taylor RS, et al. . Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol 2008;76:966–78. 10.1037/a0013786
    1. Pocock SJ, Assmann SE, Enos LE, et al. . Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practiceand problems. Stat Med 2002;21:2917–30. 10.1002/sim.1296
    1. Lockhart G, MacKinnon DP, Ohlrich V. Mediation analysis in psychosomatic medicine research. Psychosom Med 2011;73:29–43. 10.1097/PSY.0b013e318200a54b
    1. Husereau D, Drummond M, Petrou S, et al. . Consolidated Health Economic Evaluation Reporting Standards (CHEERS)—Explanation and Elaboration: A Report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. Value in Health 2013;16:231–50. 10.1016/j.jval.2013.02.002
    1. López-Bastida J, Oliva J, Antoñanzas F, et al. . Spanish recommendations on economic evaluation of health technologies. Eur J Health Econ 2010;11:513–20. 10.1007/s10198-010-0244-4
    1. Oblikue Consulting Base de Datos de Costes Sanitarios eSALUD Barcelona, 2014. Available:
    1. Feise RJ. Do multiple outcome measures require p-value adjustment? BMC Med Res Methodol 2002;2:8 10.1186/1471-2288-2-8
    1. Lindahl JR, Fisher NE, Cooper DJ, et al. . The varieties of contemplative experience: a mixed-methods study of meditation-related challenges in Western Buddhists. PLoS One 2017;12:e0176239 10.1371/journal.pone.0176239
    1. Crawford MJ, Thana L, Farquharson L, et al. . Patient experience of negative effects of psychological treatment: results of a national survey. British Journal of Psychiatry 2016;208:260–5. 10.1192/bjp.bp.114.162628
    1. Van Dam NT, van Vugt MK, Vago DR, et al. . Reiterated concerns and further challenges for mindfulness and meditation research: a reply to Davidson and Dahl. Perspect Psychol Sci 2018;13:66–9. 10.1177/1745691617727529
    1. Kuijpers HJH, van der Heijden FMMA, Tuinier S, et al. . Meditation-Induced psychosis. Psychopathology 2007;40:461–4. 10.1159/000108125
    1. Galante J, Dufour G, Benton A, et al. . Protocol for the mindful student study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress. BMJ Open 2016;6:e012300 10.1136/bmjopen-2016-012300
    1. Lovibond PF, Lovibond SH. Manual for the depression anxiety stress scales. 2nd ed Sydney: Psychology Foundation, 1995.
    1. Nhs National Institute for health research. clinical trials toolkit 2016, 2 October 2017. Available:
    1. Gutierrez-Fraile M, Garcia-Calvo C, Prieto R, et al. . Mental disorders in psychiatric outpatients in Spain. Actas Esp Psiquiatr 2011;39:349–55.
    1. Girón M, Beviá B, Medina E, et al. . [Quality of the physician-patient relation and results of clinical encounters in primary care in Alicante: a study with focal groups]. Rev Esp Salud Publica 2002;76:561–75.
    1. Gonzalez S, Gonzalez M, Iglesias MC, et al. . Psychological treatments features and outcomes in Spanish public mental health centres. International Journal of Psychology and Psychological Therapy 2014;14:17–32.
    1. Salvador-Carulla L, Garrido M, McDaid D, et al. . Financing mental health care in Spain: context and critical issues. Eur. J. Psychiat. 2006;20:29–44. 10.4321/S0213-61632006000100004
    1. Wielgosz J, Goldberg SB, Kral TRA, et al. . Mindfulness meditation and psychopathology. Annu Rev Clin Psychol 2019;15:285–316. 10.1146/annurev-clinpsy-021815-093423
    1. International Committee of medical Journal editors (ICMJE). Available: [Accessed 2 November 2017].

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