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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
  1. Jesus Montero-Marin1,
  2. Carlos Collado-Navarro2,
  3. Mayte Navarro-Gil1,
  4. Alba Lopez-Montoyo1,
  5. Marcelo Demarzo3,4,
  6. Paola Herrera-Mercadal1,
  7. Alberto Barcelo-Soler1,5,
  8. Javier Garcia-Campayo1,5
  1. 1Primary Care Prevention and Health Promotion Research Network (RedIAPP), Zaragoza, Spain
  2. 2La Plana University Hospital, Castellón, Spain
  3. 3Department of Preventive Medicine, Mente Aberta – Brazilian Center for Mindfulness and Health Promotion, Universidade Federal de São Paulo, UNIFESP, São Paulo, Brazil
  4. 4Hospital Israelita Albert Einstein, São Paulo, Brazil
  5. 5Institute of Health Research of Aragon (IIS), Zaragoza, Spain
  1. Correspondence to Dr Mayte Navarro-Gil; maytenavarrogil{at}gmail.com

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

  • RCT
  • MBSR
  • ABCT
  • depression
  • anxiety
  • adjustment

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors JG-C and CC-N conceptualised and designed the study. JM-M and CC-N wrote the first draft of the protocol. JM-M developed the statistical analysis plan. MN-G, AL-M, MD, PH-M and AB-S reviewed the manuscript content. All authors read and approved the final manuscript.

  • Funding The project received funding from DGA group (B17-17R) and the Network for Prevention and Health Promotion in Primary Care (RD16/0007/0005) grant from the Carlos III Health Institute of the Spanish Ministry of Economy and Competitiveness, cofinanced with European Union ERDF funds.

  • Disclaimer The sources of funding have no influence on the study design; collection, management, analysis and interpretation of the data; or writing of the report and the decision to submit the report for publication; and they will not have authority over any of these activities during the conducting of the trial.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Approval was obtained from the Ethics Committee of the General University Hospital of Castellón, Spain (7/2017).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement A data sharing plan has been updated in the corresponding registry record. In accordance with the International Committee of Medical Journal Editors (ICMJE), the data generated by this trial will be made available upon reasonable request to researchers i) who provide a methodologically sound proposal and ii) whose proposed use of the data has been approved by an independent ethical review committee. The data sharing plan includes all of the individual anonymized and completely de-identified participant data collected during the trial, as well as other related documents such as the study protocol, the statistical analysis plan and the data dictionary with descriptive labels. Data will become available immediately following each publication with no end date and for any analytical purpose that is related to achieve aims in the original approved proposal. The database will be encrypted and password protected. Passwords will be provided by the corresponding author to interested researchers that meet the both previously described criteria. The plan and all related documents will be downloadable at: http://doi.org/10.3886/E110024V1.

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