1. Research Plan The effect of Dialectical Behavioural Therapy (DBT) in the treatment of refractory depression in New Zealand.

2. Why? Topic – I chose this topic as I have an interest in depression, and am planning on going into mental health nursing. I quite often read literature about mental illness, and am aware of the gap in research.

3. Aim: To find out whether DBT is a successful treatment option in those aged 20-65 who suffer from refractory depression in New-Zealand. Research Question: Is DBT + drug treatment more effective at treating refractory depression in New Zealand than drug treatment alone? Methodology: I will use quantitative methodology. This method would enable me to analyze my data by verifying them on a specific set of data. Because my hypothesis is value-free, the process should be concrete and tangible, following deductive reasoning whereby I will mention my theory, hypothesis, observation and outcome. Due to controlled observations, it would enable high levels of reliability.

4. Sample: The sample used in this research plan is a randomized control study, specifically a parallel study, where there is a control group being treated with their current antidepressant medication, and a group which is manipulated/receiving the intervention of dialectical behavioural therapy as well as their current medication. The participants have been randomly assigned to each group by a computer randomisation programme, which allows for multiple perspectives from different age groups, cultures and ethnicities. Participants are randomly assigned to either the medication-only group (control group) or the medication + DBT group. There will be 35 participants per group, 70 in total. Ideally, 5 participants from each mental health community team assigned to both the control group, and the medication + DBT group. The DBT group consisting of 35 participants will be split into three separate sub-groups: one with 11 participants and two with twelve participants. The reason behind this is to provide smaller groups for client privacy and close therapeutic environment. The core skills of DBT will be introduced and practiced using the same method in all three DBT groups to minimize bias and protect rigour. I chose 5 participants from each mental health community team because although treatment-resistant depression has become a prominent health issue, sufferers of this condition may not use community mental health teams, so there will be a limited amount of available candidates for this study.

5. Inclusion criteria: Participants will be recruited from within the Waitemata District Health Board community mental health teams, through referral from their individual primary psychiatrists. This includes North team 1 and 2, West team 1 and 2 and Rodney team. It also includes MOKO which is the Maori mental health team based on the North Shore and Waitakere City, and Isa Lei which is the Pacific mental health service. This is to ensure no cultural bias. Older adults are excluded as previous research has indicated success with DBT. To be eligible for this study, participants have to be between the ages of 20-65 and have a diagnosis of current unipolar major depression according to DSM-IV, and are diagnosed as treatment-resistant. The definition of treatment-resistant depression is “A lack of satisfactory response after trial of two antidepressants given sequentially at an adequate dose for an adequate time (with or without psychological therapy)” (New Zealand Guidelines Group, 2008). Participants are required to have ongoing consultations with their psychologist/psychotherapist throughout the study, and are required to be taking a stable dose of current antidepressant (up to 8 weeks before the study entry).

6. Exclusion criteria: This excludes those with bipolar disorder, those with psychotic symptoms and those trialing ECT. In addition, participants with active suicidal ideation and those experiencing severe hospitalization episodes are excluded.

7. Instrument: Before commencement of the study, participants are each required to attend an individual interview held by their assigned psychiatrist affiliated with their community mental health team, to determine eligibility, and record their first baseline diagnostic evaluation in the form of a Hamilton Rating Scale for Depression (Ham-D), and the Beck Depression Inventory (BDI, BDI-II). The DBT group will meet each week at a community venue for two and a half hours, to learn new skills such as mindfulness, interpersonal effectiveness, emotional regulation and distress tolerance. Each skill will take three weeks, a full cycle taking twelve weeks. This cycle will then be repeated for reinforcement, bringing the total hours per skill to 15 hours in total throughout the 24 weeks. There will be 3 DBT groups in total, to suit community mental health team geographical placement, but all will use the same core course material to decrease bias.

8. Each individual in both groups are scored by the Ham-D and the BDI, BDI-II in the initial interview and again at week four, eight, twelve and sixteen, twenty and twenty-four of the DBT. A follow up consultation with scoring will take place approximately 3 months and 6 months after DBT to measure efficacy or relapse. The DBT group will meet each week at a community venue for two and a half hours, to learn new skills such as mindfulness, interpersonal effectiveness, emotional regulation and distress tolerance. Each skill will take three weeks, a full cycle taking twelve weeks. This cycle will then be repeated for reinforcement, bringing the total hours per skill to 15 hours in total throughout the 24 weeks. There will be 3 DBT groups in total, to suit community mental health team geographical placement, but all will use the same core course material to decrease bias.

9. Data Collection: Participants who are eligible to be part of this research are required to complete the BDI at their individual interview. Their assigned psychiatrist is also responsible for completing their HAM-D. This will be repeated throughout the research to evaluate change in mood, at week four, eight, twelve and sixteen, twenty and twenty-four of the DBT. A follow up consultation with scoring will take place approximately 3 months and 6 months after DBT to measure efficacy or relapse. The Beck Depression Inventory is a self-report inventory which consists of 21 groups of statements, whereby the participant chooses one statement in each group that best describes the way they have been feeling over the previous two week, including the day of the Beck questionnaire. The groups include sadness, pessimism, past failure, loss of pleasure, guilty feelings, punishment feelings, self-dislike, self-criticalness, suicidal thoughts or wishes, crying, agitation, loss of interest, indecisiveness, worthlessness, loss of energy, changes in sleeping pattern, irritability, changes in appetite, concentration difficulty, tiredness or fatigue, and loss of interest in sex. The participant is to choose from the numbers 0-3 whereby 0 scores low for depression and 3 scores higher (Te Pou, 2010).

10. The Hamilton rating scale for depression is a clinician-administered scale which consists of 21 groups of statements, whereby the participant chooses one statement in each group that best describes the way they are currently feeling. There are 3-5 possible responses which increase in severity indicating depression. The groups which consist of these responses include depressed mood, feelings of guilt, suicide, insomnia early, insomnia middle, insomnia late, work and activities, retardations: psychomotor, agitation, anxiety (psychological), anxiety somatic, somatic symptoms (gastrointestinal), somatic symptoms general, genital symptoms, hypochondriasis, loss of weight, insight, diurnal variation, depersonalization and derealisation, paranoid symptoms, obsessive and compulsive symptoms. The medication-only group will continue to see their MHCT key-worker weekly if that is what they are used to, so as to not compromise their mental wellbeing. Participants in the medication + DBT group will be involved in weekly group DBT sessions lasting 2 and a half hours, will have weekly phone calls with their assigned psychotherapist and will continue to see their MHCT key-worker weekly.

11. The DBT group consists of their assigned psychiatrist, psychologist and a psychotherapist, (one per community mental health team), all whom have been trained in DBT. There are two components in DBT, one being weekly telephone contact with each participant where they have time to discuss anything they like with their psychotherapist, usually depression-related daily concerns. The second component is the DBT group, where participants work collaboratively through skill based modules encapsulating core mindfulness, interpersonal effectiveness, emotional regulation and distress tolerance. Mindfulness skills help participants to live in the moment, experiencing emotions in perspective. Distress tolerance helps participants accept and cope with distressing events, without intense reactions. Emotional regulation helps the participants increase mindfulness to emotions and learn distress tolerance techniques. Interpersonal effectiveness help participants by learning strategies to cope with interpersonal conflict, as well as understanding what one needs and saying no when necessary.

12. Using the HAM-D and BDI will ensure rigour, as the specific questions will exclude possibility of misinterpreting data. The DBT professional team will help ensure rigour, as the participants are assigned the same psychiatrist, psychologist and psychotherapist throughout the whole research study. I have ensured concurrent validity, as Ham-D and BDI are previous validated measures. The size of the subject population as well as the time given for DBT group to allow therapeutic effects to become instilled in the participants is forms of validity. I have ensured reliability in using the alternative form method, with both Ham-D and BDI. This enables reliability in relatively consistent results in comparison with each scoring method throughout the research.

13. Cultural Issues: It is also mandatory to consult with Nga kai Tataki/Maori Regional Research to ensure safe practice. Research should meet the rights, needs and interests of Maori and consideration must be made to the impact of research on Maori, under the Treaty of Waitangi (WDHB Knowledge Centre, 2007).

14. Ethical Issues: Before this research is commenced, it must be registered with the WDHB Knowledge Centre, where the research plan is proposed to the managers of the service. This includes completing the WDHB Approval of Research/Audit form, and obtaining an organisational sign-off and locality assessment where researchers are assessed in assuring the research will meet established ethical standard, as well as whether the researcher has made appropriate local study arrangements. Also mandatory is the completion of the National application form for ethical approval of a research project, also known as NAF-2009-v1 (WDHB Knowledge Centre, 2008). This research plan must also be submitted to the New Zealand Health and Disability Ethics Committee, in particular X and Y committees who are responsible for reviewing proposals in Auckland. The role of these committees are to protect humans involved in research by preventing potentially harmful research, and ensuring the participants have given informed consent and are aware of what their participation will involve (New Zealand Health and Disability Ethics Committees, 2010)

15. The Privacy Act (1993) is important in ensuring the collection, use, storage, retention and disclosure of personal information (Privacy Commissioner, 2010). Informed consent is a priority before research is commenced, ensuring that adequate information is provided to enable informed choice, that the information provided is in a manner that would be understood by each participant, and that the consent is voluntary in that it is not by coercion (Ministry of Health, 2009). Confidentiality will be maintained by using the first and last letters of their name (their initials), for example Lizzie Jansen will become LJ. If at any time during the course of this research a participant experiences worsening depression, it is up to their discretion whether they wish to continue, and the researcher will work in collaboration with the participant to ensure they receive the appropriate care.

16. Data Analysis: Throughout this research study, scoring from both the Ham-D and BDI will be analyzed. This includes looking at both the control group, and the medication + DBT group’s scores for week 4, 8, 12, 16, 20, and 24, and again 4 months and 6 months after DBT. I will use descriptive statistics to analyze this research data. The scores will be used to measure the central tendency – the mean, the median, and the mode. The mean is the middle score and will also be calculated to acknowledge extreme scores. The median is the numeric value separating the higher half of a sample from the lower half. The mode is the frequently occurring score. The mean, median and mode will then be used to work out measures of dispersion, such as the range, interquartile range, variation ratio, and standard deviation. The range is the difference between the highest and lowest score; the interquartile range is the spread of the middle 50% of scores. The variation ratio is the proportion of scores obtained which are not at the modal value. The standard deviation is a measure of dispersal that is of special relevance to the normal distribution; it is the square root of the variance. It takes account of every score, and is a sensitive dispersion measure (Social Research Methods, 2006). Once these statistics are worked out, I would then create a graph for both the control group and the DBT + medication group, showing the monthly difference, and to clearly see the efficacy/relapse.

17. Expected Outcomes/Application to Practice: This research will confirm the need for DBT in mental health today, and will increase the awareness of the use of DBT in treatment-resistant depression. Although a small study sample is used, it will help cement future larger-scale research incorporating all community mental health teams in New Zealand. This study will improve professional practice by reinforcing the clinical use of Beck Depression Inventory and the Hamilton rating scale for depression, as well as raising awareness of treatment-resistant depression, in the aim of decreasing the statistics for this illness.

18. References Brassington, J., Krawitz, R. (2006). Australasian dialectical behavioural therapy pilot outcome study: effectiveness, utility and feasibility. Royal Australian and New Zealand College of Psychiatrists. Australasian Psychiatry, 14 (3), 313-319 Dewe, C., Krawitz, R. (2007). Component analysis of dialectical behavior therapy skills training.The Royal Australian and New Zealand College of Psychiatrists. Australasian Psychiatry,15 (3), 222-225 Hamilton M. A (1960). A rating scale for depression. J Neurol Neurosurg Psychiatry, 23:56–62. Retrieved March 22, 2010, from: http://www.servier.com/App_Download/Neurosciences/Echelles/HDRS.pdf Harley, R., Sprich, S., Safren, S., Jacobo, M., Fava, M. (2008). Adaptation of Dialectical Behavior Therapy Skills Training Group for Treatment- Resistant Depression.The Journal of Nervous and Mental Disease, 196 (2), 136-143 Lau, A. M., McMain, F.S. (2005). Integrating Mindfulness Meditation With Cognitive and Behavioural Therapies: The Challenge of Combining Acceptance- and Change-Based Strategies.Can J Psychiatry, 50 (13), 863-869 Lynch, R.T., Morse, Q.J., Mendelson, T., Robins, J.C. (2003).Dialectical Behavior Therapy for Depressed Older Adults: A Randomized Pilot Study. Am J Geriatr Psychiatry, 11 (1), 33-45 Ministry of Health. (2009). Data and Statistics: Informed Consent. Retrieved March 22, 2010, from:http://www.moh.govt.nz/moh.nsf/indexmh/dataandstatistics-survey-info#informedconsent

19. New Zealand Guidelines Group. (2008).Algorithm 2a Management of severe depression in adults in primary care. Retrieved March 22, 2010, from: http://www.nzgg.org.nz/guidelines/0152/NZG92_Summary_web.pdf New Zealand Health and Disability Ethics Committees. (2010). Northern X and Y Committees: Jurisdiction. Retrieved March 21, 2010, from:http://www.ethicscommittees.health.govt.nz/moh.nsf/indexcm/ethics-about-northern?Open&m_id=2.2 Privacy Commissioner. (2010). The Privacy Act and Codes. Retrieved March 21, 2010, fromhttp://www.privacy.org.nz/the-privacy-act-and-codes/ Te Pou. (2010). The National Centre of mental health research, information and workforce development: Symptom rating scales: Beck Depression Inventory. Retrieved March 20, 2010, from: http://www.tepou.co.nz/file/Information-Programme/beck.pdf Wagner, W.A., Rizvi, L.S., Harned, S.M. (2007). Applications of Dialectical Behavior Therapy to the Treatment of Complex Trauma-Related Problems: When One Case Formulation Does Not Fit All. Journal of Traumatic Stress, 20 (4), 391-400 Waitemata District Health Board. (2008). Knowledge centre: Approval Process: Conducting Research at Waitemata DHB. Retrieved March 21, 2010, from http://www.knowledgecentre.co.nz/ApprovalProcess/tabid/57/language/en-NZ/Default.aspx Waitemata District Health Board. (2008). Knowledge centre: Cultural consultation process. Retrieved March 21, 2010, from: http://www.knowledgecentre.co.nz/ApprovalProcess/NgaKaiTatakiMRRC/tabid/67/language/en-NZ/Default.aspx World Health Organization (2010). Depression. Retrieved March 21, 2010, from http://www.who.int/mental_health/management/depression/definition/en/ World Health Organization Regional Office for Europe’s Health Evidence Network (HEN) (2005) What are the most effective diagnostic and therapeutic strategies for the management of Depression in specialist care? Copenhagen, Denmark: Möller, H.J., Henkel, V.