Skip to main content
Top
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Morita therapy for depression and anxiety (Morita Trial): study protocol for a pilot randomised controlled trial

Authors: Holly Victoria Rose Sugg, David A. Richards, Julia Frost

Published in: Trials | Issue 1/2016

Login to get access

Abstract

Background

Morita Therapy, a psychological therapy for common mental health problems, is in sharp contrast to established western psychotherapeutic approaches in teaching that undesired symptoms are natural features of human emotion rather than something to control or eliminate. The approach is widely practiced in Japan, but untested and little known in the UK. A clinical trial of Morita Therapy is required to establish the effectiveness of Morita Therapy for a UK population. However, a number of methodological, procedural and clinical uncertainties associated with such a trial first require addressing.

Methods/Design

The Morita Trial is a mixed methods study addressing the uncertainties associated with an evaluation of Morita Therapy compared with treatment as usual for depression and anxiety. We will undertake a pilot randomised controlled trial with embedded qualitative study. Sixty participants with major depressive disorder, with or without anxiety disorders, will be recruited predominantly from General Practice record searches and randomised to receive Morita Therapy plus treatment as usual or treatment as usual alone. Morita Therapy will be delivered by accredited psychological therapists. We will collect quantitative data on depressive symptoms, general anxiety, attitudes and quality of life at baseline and four month follow-up to inform future sample size calculations; and rates of recruitment, retention and treatment adherence to assess feasibility. We will undertake qualitative interviews in parallel with the trial, to explore people’s views of Morita Therapy. We will conduct separate and integrated analyses on the quantitative and qualitative data.

Discussion

The outcomes of this study will prepare the ground for the design and conduct of a fully-powered evaluation of Morita Therapy plus treatment as usual versus treatment as usual alone, or inform a conclusion that such a trial is not feasible and/or appropriate. We will obtain a more comprehensive understanding of these issues than would be possible from either a quantitative or qualitative approach alone.

Trial registration

Current Controlled Trials ISRCTN17544090 registered on 23 July 2015.
Appendix
Available only for authorised users
Literature
1.
go back to reference Andrews G, Sanderson K, Slade T, Issakidis C. Why does the burden of disease persist? Relating the burden of anxiety and depression to effectiveness of treatment. Bull World Health Organ. 2000;78:446–54.PubMedPubMedCentral Andrews G, Sanderson K, Slade T, Issakidis C. Why does the burden of disease persist? Relating the burden of anxiety and depression to effectiveness of treatment. Bull World Health Organ. 2000;78:446–54.PubMedPubMedCentral
3.
go back to reference Layard R. The depression report: A new deal for depression and anxiety disorders, (No. 15). Centre for Economic Performance, LSE; 2006. Layard R. The depression report: A new deal for depression and anxiety disorders, (No. 15). Centre for Economic Performance, LSE; 2006.
4.
go back to reference Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, et al. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013;10(11):e1001547.CrossRefPubMedPubMedCentral Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, et al. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013;10(11):e1001547.CrossRefPubMedPubMedCentral
5.
go back to reference Andrews G, Henderson S, Hall W. Prevalence, comorbidity, disability and service utilisation Overview of the Australian National Mental Health Survey. Br J Psychiatry. 2001;178:145–53.CrossRefPubMed Andrews G, Henderson S, Hall W. Prevalence, comorbidity, disability and service utilisation Overview of the Australian National Mental Health Survey. Br J Psychiatry. 2001;178:145–53.CrossRefPubMed
6.
go back to reference Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). Jama. 2003;289:3095–105.CrossRefPubMed Kessler RC, Berglund P, Demler O, Jin R, Koretz D, Merikangas KR, et al. The epidemiology of major depressive disorder: results from the National Comorbidity Survey Replication (NCS-R). Jama. 2003;289:3095–105.CrossRefPubMed
7.
go back to reference O'Brien M, Singleton N, Bumpstead R, Office For National Statistics LSSD. Psychiatric morbidity among adults living in private households, 2000. London (United Kingdom): The Stationery Office; 2001. O'Brien M, Singleton N, Bumpstead R, Office For National Statistics LSSD. Psychiatric morbidity among adults living in private households, 2000. London (United Kingdom): The Stationery Office; 2001.
8.
go back to reference Keller MB. Long-term treatment of recurrent and chronic depression. J Clin Psychiatry. 2001;62:3–5.CrossRefPubMed Keller MB. Long-term treatment of recurrent and chronic depression. J Clin Psychiatry. 2001;62:3–5.CrossRefPubMed
9.
go back to reference Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593–602.CrossRefPubMed Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005;62:593–602.CrossRefPubMed
10.
go back to reference National Institute for Health and Clinical Excellence. Depression: Management of depression in primary and secondary care, National Institute for Health and Clinical Excellence; 2009. National Institute for Health and Clinical Excellence. Depression: Management of depression in primary and secondary care, National Institute for Health and Clinical Excellence; 2009.
11.
go back to reference National Collaborating Centre for Mental Health. Generalised Anxiety Disorder in Adults: Management in Primary, Secondary and Community Care, Leicester and London, The British Psychological Society and the Royal College of Psychiatrists (NICE Clinical Guidelines, No. 113); 2011. National Collaborating Centre for Mental Health. Generalised Anxiety Disorder in Adults: Management in Primary, Secondary and Community Care, Leicester and London, The British Psychological Society and the Royal College of Psychiatrists (NICE Clinical Guidelines, No. 113); 2011.
12.
go back to reference Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, et al. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004;25:119–42.CrossRefPubMed Rush AJ, Fava M, Wisniewski SR, Lavori PW, Trivedi MH, Sackeim HA, et al. Sequenced treatment alternatives to relieve depression (STAR*D): rationale and design. Control Clin Trials. 2004;25:119–42.CrossRefPubMed
14.
go back to reference Clark DM, Layard R, Smithies R, Richards DA, Suckling R, Wright B. Improving access to psychological therapy: Initial evaluation of two UK demonstration sites. Behav Res Ther. 2009;47:910–20.CrossRefPubMedPubMedCentral Clark DM, Layard R, Smithies R, Richards DA, Suckling R, Wright B. Improving access to psychological therapy: Initial evaluation of two UK demonstration sites. Behav Res Ther. 2009;47:910–20.CrossRefPubMedPubMedCentral
15.
go back to reference Hollon SD, Munoz RF, Barlow DH, Beardslee WR, Bell CC, Bernal G, et al. Psychosocial intervention development for the prevention and treatment of depression: promoting innovation and inreasing access. Biol Psychiatry. 2002;52:610–30.CrossRefPubMed Hollon SD, Munoz RF, Barlow DH, Beardslee WR, Bell CC, Bernal G, et al. Psychosocial intervention development for the prevention and treatment of depression: promoting innovation and inreasing access. Biol Psychiatry. 2002;52:610–30.CrossRefPubMed
16.
go back to reference Morita M, Kondō A, LeVine P. Morita Therapy and the True Nature of Anxiety-Based Disorders. Albany: State University of New York Press; 1998. Morita M, Kondō A, LeVine P. Morita Therapy and the True Nature of Anxiety-Based Disorders. Albany: State University of New York Press; 1998.
17.
go back to reference Nakamura K, Kitanishi K, Maruyama S, Ishiyama FI, Ito K, Tatematsu K, et al. Guidelines for practising outpatient morita therapy. Tokyo: Japanese Society for Morita Therapy; 2010. Nakamura K, Kitanishi K, Maruyama S, Ishiyama FI, Ito K, Tatematsu K, et al. Guidelines for practising outpatient morita therapy. Tokyo: Japanese Society for Morita Therapy; 2010.
18.
go back to reference Ogawa B. Desire For Life: The Practitioner’s Introduction to Morita Therapy for the Treatment of Anxiety Disorders. Indiana: XLibris Publ; 2013. Ogawa B. Desire For Life: The Practitioner’s Introduction to Morita Therapy for the Treatment of Anxiety Disorders. Indiana: XLibris Publ; 2013.
19.
go back to reference Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Br Med J. 2008;337:a1655.CrossRef Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Br Med J. 2008;337:a1655.CrossRef
20.
21.
go back to reference Richards DA, Hill JJ, Gask L, Lovell K, Chew-Graham C, Bower P, et al. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. Br Med J. 2013;347:f4913.CrossRef Richards DA, Hill JJ, Gask L, Lovell K, Chew-Graham C, Bower P, et al. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. Br Med J. 2013;347:f4913.CrossRef
22.
go back to reference Wiles N, Thomas L, Abel A, Ridgway N, Turner N, Campbell J, et al. Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial. Lancet. 2013;381:375–84.CrossRefPubMed Wiles N, Thomas L, Abel A, Ridgway N, Turner N, Campbell J, et al. Cognitive behavioural therapy as an adjunct to pharmacotherapy for primary care based patients with treatment resistant depression: results of the CoBalT randomised controlled trial. Lancet. 2013;381:375–84.CrossRefPubMed
23.
go back to reference Rhodes S, Richards DA, Ekers D, McMillan D, Byford S, Farrand PA, et al. Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial. Trials. 2014;15:29.CrossRefPubMedPubMedCentral Rhodes S, Richards DA, Ekers D, McMillan D, Byford S, Farrand PA, et al. Cost and outcome of behavioural activation versus cognitive behaviour therapy for depression (COBRA): study protocol for a randomised controlled trial. Trials. 2014;15:29.CrossRefPubMedPubMedCentral
24.
go back to reference Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. 2nd ed. Thousan Oaks: Sage Publications, Inc.; 2011. Creswell JW, Plano Clark VL. Designing and conducting mixed methods research. 2nd ed. Thousan Oaks: Sage Publications, Inc.; 2011.
25.
go back to reference Borglin G. The value of mixed methods for researching complex interventions. In: Richards DA, Hallberg IR, editors. Complex Interventions in Health: An overview of research methods. Oxon: Routledge; 2015. p. 29–45. Borglin G. The value of mixed methods for researching complex interventions. In: Richards DA, Hallberg IR, editors. Complex Interventions in Health: An overview of research methods. Oxon: Routledge; 2015. p. 29–45.
26.
go back to reference Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995;14:1933–40.CrossRefPubMed Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995;14:1933–40.CrossRefPubMed
27.
go back to reference Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The Mini-Cog: a cognitive ‘vital signs’ measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000;15:1021–7.CrossRefPubMed Borson S, Scanlan J, Brush M, Vitaliano P, Dokmak A. The Mini-Cog: a cognitive ‘vital signs’ measure for dementia screening in multi-lingual elderly. Int J Geriatr Psychiatry. 2000;15:1021–7.CrossRefPubMed
28.
go back to reference Whooley MA, Avins AL, Miranda J, Browner WS. Case-finding instruments for depression. J Gen Intern Med. 1996;12:439–45.CrossRef Whooley MA, Avins AL, Miranda J, Browner WS. Case-finding instruments for depression. J Gen Intern Med. 1996;12:439–45.CrossRef
29.
go back to reference First MB, Williams JBW, Spitzer RL, Gibbon M. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Clinical Trials Version (SCID-CT). New York: Biometrics Research, New York State Psychiatric Institute; 2007. First MB, Williams JBW, Spitzer RL, Gibbon M. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Clinical Trials Version (SCID-CT). New York: Biometrics Research, New York State Psychiatric Institute; 2007.
33.
go back to reference LeVine P. Morita‐Based Therapy and Its Use Across Cultures in the Treatment of Bulimia Nervosa. J Counsel Dev. 1993;72(1):82–90.CrossRef LeVine P. Morita‐Based Therapy and Its Use Across Cultures in the Treatment of Bulimia Nervosa. J Counsel Dev. 1993;72(1):82–90.CrossRef
34.
go back to reference LeVine P. Classic Morita Therapy: Consciousness, Nature and Trauma, State University of New York Press, USA. (In Press) LeVine P. Classic Morita Therapy: Consciousness, Nature and Trauma, State University of New York Press, USA. (In Press)
35.
go back to reference Ogawa B. A River to Live By: The 12 Life Principles of Morita Therapy. Philadelphia: Xlibris/Random House; 2007. Ogawa B. A River to Live By: The 12 Life Principles of Morita Therapy. Philadelphia: Xlibris/Random House; 2007.
36.
go back to reference Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–7.CrossRefPubMed
37.
go back to reference Ware JE, Kosinski M, Dewey JE, Gandek B. SF-36 health survey: manual and interpretation guide. Lincoln: Quality Metric Inc; 2000. Ware JE, Kosinski M, Dewey JE, Gandek B. SF-36 health survey: manual and interpretation guide. Lincoln: Quality Metric Inc; 2000.
38.
go back to reference Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRefPubMed Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRefPubMed
39.
go back to reference Richards DA, Mullan EG, Ishiyama FI, Nakamura K. Developing an Outcome Framework for Measuring the Impact of Morita Therapy: A Report from a Consensus Development Process. J Morita Ther. 2011;22:165–73. Richards DA, Mullan EG, Ishiyama FI, Nakamura K. Developing an Outcome Framework for Measuring the Impact of Morita Therapy: A Report from a Consensus Development Process. J Morita Ther. 2011;22:165–73.
40.
go back to reference Taylor M. Interviewing. In: Holloway I, editor. Qualitative Research in Health Care. Maidenhead: Open University Press; 2011. p. 29–55. Taylor M. Interviewing. In: Holloway I, editor. Qualitative Research in Health Care. Maidenhead: Open University Press; 2011. p. 29–55.
41.
go back to reference Hill JJ, Kuyken W, Richards DA. Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial. Trials. 2014;15:452.CrossRefPubMedPubMedCentral Hill JJ, Kuyken W, Richards DA. Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial. Trials. 2014;15:452.CrossRefPubMedPubMedCentral
43.
go back to reference Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1.CrossRef Lancaster GA. Pilot and feasibility studies come of age! Pilot Feasibility Stud. 2015;1(1):1.CrossRef
45.
go back to reference Ritchie J, Spencer L, O’Connor W. Qualitative research practice: A guide for social science students and researchers. London: Sage; 2003. Ritchie J, Spencer L, O’Connor W. Qualitative research practice: A guide for social science students and researchers. London: Sage; 2003.
46.
go back to reference Thorne S. Data analysis in qualitative research. Evid Based Nurs. 2000;3:68–70.CrossRef Thorne S. Data analysis in qualitative research. Evid Based Nurs. 2000;3:68–70.CrossRef
47.
go back to reference Miles MB, Huberman AM. Qualitative data analysis: An expanded sourcebook. London: Sage; 1994. Miles MB, Huberman AM. Qualitative data analysis: An expanded sourcebook. London: Sage; 1994.
48.
go back to reference Dingwall R, Murphy E, Watson P, Greatbatch D, Parker S. Catching goldfish: quality in qualitative research. J Health Serv Res Policy. 1998;3(3):167–72.PubMed Dingwall R, Murphy E, Watson P, Greatbatch D, Parker S. Catching goldfish: quality in qualitative research. J Health Serv Res Policy. 1998;3(3):167–72.PubMed
49.
go back to reference O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.CrossRef O’Cathain A, Hoddinott P, Lewin S, Thomas KJ, Young B, et al. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers. Pilot Feasibility Stud. 2015;1:32.CrossRef
50.
go back to reference World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for edical research involving human subjects. Bull World Health Organ. 2001;79:373. World Medical Association. World Medical Association Declaration of Helsinki. Ethical principles for edical research involving human subjects. Bull World Health Organ. 2001;79:373.
52.
go back to reference Department of Health. Mental Capacity Act. London: HMSO; 2005. Department of Health. Mental Capacity Act. London: HMSO; 2005.
55.
go back to reference The National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) glossary: The National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) Q8 glossary. http://www.netscc.ac.uk/glossary/. Accessed 25 Sep 2015. The National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) glossary: The National Institute for Health Research Evaluation Trials and Studies Coordinating Centre (NETSCC) Q8 glossary. http://​www.​netscc.​ac.​uk/​glossary/​. Accessed 25 Sep 2015.
56.
go back to reference Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.CrossRefPubMedPubMedCentral Arain M, Campbell MJ, Cooper CL, Lancaster GA. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010;10:67.CrossRefPubMedPubMedCentral
57.
go back to reference O’Cathain A, Murphy E, Nicholl J. The quality of mixed methods studies in health services research. J Health Serv Res Policy. 2008;13:92–8.CrossRefPubMed O’Cathain A, Murphy E, Nicholl J. The quality of mixed methods studies in health services research. J Health Serv Res Policy. 2008;13:92–8.CrossRefPubMed
58.
go back to reference O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. British Medical Journal Open. 2013, 3. doi: 10.1136/bmjopen-2013-002889 O’Cathain A, Thomas KJ, Drabble SJ, Rudolph A, Hewison J. What can qualitative research do for randomised controlled trials? A systematic mapping review. British Medical Journal Open. 2013, 3. doi: 10.​1136/​bmjopen-2013-002889
Metadata
Title
Morita therapy for depression and anxiety (Morita Trial): study protocol for a pilot randomised controlled trial
Authors
Holly Victoria Rose Sugg
David A. Richards
Julia Frost
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1279-3

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue