1. Lisa A. Uebelacker Butler Hospital Alpert Medical School of Brown University

2. Outline Where I’m coming from How I became involved in yoga research What is depression? Why might yoga be helpful for depression? Why conduct randomized clinical trials? Previous research Elements of good study design Ongoing studies Key challenges

3. Where I’m coming from: Clinical psychologist Trained in quantitative research methods Depression researcher Psychotherapist and psychotherapy researcher Yoga practitioner

4. How I became involved in yoga research…. 1998: MBSR class 2004: Began practicing yoga Limitations of cognitive therapy Trends in psychotherapy research Concerns about sitting meditation 2005: Convened a small group to talk about yoga research Many grant submissions later….

5. What is depression? The mustard seed

6. What is depression? Presence of at least 5 of the following symptoms, most of the day, nearly every day, for at least 2 weeks: Sad mood Loss of interest Insomnia or excessive sleep Increased or decreased appetite Low energy Worthlessness or guilt Decreased concentration or ability to make decisions Psychomotor agitation or retardation Suicidality Ranges from mild to severe

7. Why might yoga be helpful for depression? Decreased stress reactivity Regulation of relevant neurotransmitters Improved sleep Physical activity; conditioning the body Decreased rumination and increased focus on present moment Decreased “fusion” with thoughts; cultivation of observer self Enjoyment of the practice and increased self-efficacy Increased energy or increased flow of prana Sense of interconnectedness of life Feeling a part of a community Other?

8. Why conduct randomized clinical trials on yoga for depression? Influence public health policy Provide an alternative to other depression treatments Understand impact on other outcomes specifically in depressed individuals (e.g., pain) Begin to understand biological and cognitive mechanisms by which yoga may have an impact on depression Document safety

9. Previous Research 7 randomized controlled trials (RCTs) of yoga for depression + 1 controlled trial Some evidence that yoga is useful for depression Studies varied a lot in terms of research designs Most studies provided few details on methodology and had several weaknesses in study design In sum, previous research hopeful but not conclusive (Uebelacker et al., 2010)

10. Elements of good study design: How can we show yoga “works?” Random assignment to groups Careful thought about the control group Clear documentation of randomization procedures Clear explanation of intervention (manual) Documentation that instructors adhered to the manual Blind evaluation of outcome Utilization of a validated outcome measure Follow-up to examine whether gains are maintained

11. Prenatal yoga for depression Pregnant women Need more depression treatment options Want treatments that involve movement and that feel healthy Have lots of aches and pains, and a constantly growing and changing body Treatment development study (NIMH R34; PI: Battle) Objectives: Develop and refine a treatment manual that focuses on: Attention to baby and the present moment Preparing for birth Safety Assess feasibility and acceptability of classes Prepare for larger clinical trial

12. Holistic Approaches to Depression Randomized controlled trial (NINR R01; PI: Uebelacker) Targets individuals who are taking an antidepressant medication but continue to have symptoms and are yoga-naïve. Compares 10 weeks of twice-weekly yoga to a twice-weekly health education group Hatha yoga class are moderately vigorous and involve breathing exercises, asana series, and short guided meditation Primary outcome: depression Secondary outcomes: work and family functioning; physical health Mechanisms: Biological markers of inflammation, stress hormone levels, rumination, mindfulness 12 people enrolled so far; target = 150

13. Key challenges What questions do we ask? (What should the control group be?) Does the personality of the teacher have an effect? What style of yoga do we use? Does it matter if class sizes are (very) small? What if we don’t find differences between groups?

14. Collaborators Ana Abrantes Cynthia Battle Courtney Beard Julie Cloutier Jennifer DeAngelis Gary Epstein-Lubow Nicole Ford Brandon Gaudiano Tom Gillette Susan Hagan Patricia Hottel Morganne Kraines Richard Liu Joanne Matthew Gretchen Mayhew Ivan Miller Tracy Ramos Jennifer Spaziano David Strong Kaeli Sutton Geoff Tremont Audrey Tyrka Amy Uber Vanessa Weiner Amy Weintraub