Objective adherence and study methods for VETMIND: A mindfulness meditation RCT for combat veterans with PTSD

1. Objective adherence and study methods for VETMIND:A mindfulness meditation RCT for combat veterans with PTSD Helan� Wahbeh, ND Assistant Professor Oregon Health & Science University April 16, 2011 1

2. Brief background Vet Mind study methods Study progress Objective adherence and iMINDr 2

3. What is Mindfulness? Central element: attention in the current moment Focus on internal (on bodily sensations, breath, thoughts, emotions) Focus on external (on sights, sounds, smell) Continually return attention to target whenever mind wanders Non-judgmental acceptance Skills taught independently of the religious/cultural traditions 3

4. Mindfulness Instruction and Practice Sitting Meditation 4 In general mindfulness based therapies incorporate various exercises like a guided body scan where attention is brought to each part of the body Or a guided sitting meditation where participants focus on a target like thoughts floating by on a movie screen or like clouds in the sky. Some mindfulness classes include gentle Hatha yoga poses to focus participants attention. There also daily activities like describing pleasant and unpleasant events and reactions to them. In general mindfulness based therapies incorporate various exercises like a guided body scan where attention is brought to each part of the body Or a guided sitting meditation where participants focus on a target like thoughts floating by on a movie screen or like clouds in the sky. Some mindfulness classes include gentle Hatha yoga poses to focus participants attention. There also daily activities like describing pleasant and unpleasant events and reactions to them.

5. Clinical Application Meditation 2106 Mindfulness meditation 529 Used successfully in a variety of populations including veterans with PTSD (Finucane, 2006) Positive clinical outcomes from meditation therapy for a variety of mental and physical illnesses (Grossman, 2004) Depressive symptoms or relapse (Teasdale, 2000) Anxiety (Miller, 1995) Suicidal behavior (Williams, 2006) Sleep disturbances (Carlson, 2005) Stress, quality of life and cortisol levels (Carlson, 2007) 5

6. How is mindfulness eliciting clinical effects? Potential mechanistic pathways 6

7. Why PTSD? PTSD is a serious and costly health issue Combat veterans are a rapidly growing group Pathophysiology reduces ceiling effect 7

8. Study Design 100 combat veterans with PTSD randomized into one of four groups Six �training� sessions (1x/week) 20 minutes daily home practice 8

9. Trainings Mindfulness Meditation- Body Scan Slow Breathing Mindfulness plus Slow Breathing Sitting Quietly 9

10. Measures pre- and post-training Primary Outcomes Autonomic Nervous system-Hyper-arousal symptoms, Heart rate, HRV, Blood pressure Frontal Lobe Activity-Attention Network Task, EEG event-related negativity, Intrusive Thoughts Scale HPA Function-Awakening cortisol Secondary/Exploratory Outcomes Psychological-General Self-efficacy, Expectancy, Absorption, Life Events, Personality, Depression, Mood, Perceived Stress, Sleep, Mindfulness Genotyping-5HTTLRP, hsCRP Cognitive Measures-memory, verbal fluency, executive function Ecological Momentary Assessment 10

11. Ecological Momentary Assessment Randomly assessed 4x/24 hr period 30 second voice recording Where are you, who are you with, what are you doing Five 6 pt Likert scale questions How sleepy are you right now? (Wide awake-almost asleep) How do you currently feel? (Fully calm-fully nervous/stressed) What kind of situation are you currently in? (Fully relaxed-fully demanding) How well are you coping with the current situation? (Fully overwhelmed-fully coping Where is the main focus of your current thoughts? (Fully in the present-fully in the future or past) Go No-Go- sustained attention 11

12. Adherence Elucidates whether actually doing the intervention moderates outcomes Drug trials regularly use Medication Event Monitoring Systems and pill counts No such standards exist in mind-body medicine research 12

13. Adherence Mind-body medicine: two aspects Class Instruction Easily collected through attendance records Rarely reported Meta-analysis-relationship class hours/effect size Home Practice Usually through self-report Rarely reported Self-report diaries easily altered 13

14. Objective Adherence Results must be interpreted with caution Uncertainty due to the unknown parameter of how much they practiced at home Prior to this work, no mind-body clinical trial had reported using objective methods to measure home practice 14

15. Objective Adherence: Take One iPod Nano, 7 copies same track Play count, last played date, and last played time was collected through iTunes 7 participants used this method Limitations Did not play correct track Recorded only beginning time track was last played If ppt did not turn of iPod, excessive play counts 15

16. Objective Adherence: Take Two iMINDr-custom software application developed with engineer for iTouch Research assistant sets up iMINDr icon appears leads to meditation Program records data, uploaded each visit Date, time, action [start, stop, pause, volume change] Export to a Microsoft Excel file with raw data, daily summary statistics, and study summary statistics for each participant 16

17. Objective Adherence 17

18. Recruitment 18

19. Participants All male Era OEF/OIF: 32% Vietnam: 62% Other: 5% Marital Status -Married 54% Race Caucasian 89% Asian 5% Hispanic 3% Native American 5% Age 51 � 13.8 Education <12: 3% 12-14: 57% 15-16: 27% >16: 13% 19

20. Participant Reactions Participants rated the trainings as logical (1-9, 9 very logical) Mindfulness Meditation 6.2 � 2.1 Slow Breathing 6.3 � 2.0 Mindfulness and Slow Breathing 6.5 � 1.9 Book on tape 5.7 � 2.4 ns 20

21. Participant Reactions Participants felt they would improve their PTSD symptoms by 32-42% Mindfulness Meditation 40% � 25% Slow Breathing 36% � 26% Mindfulness and slow breathing 42% � 25% Book on tape 34% � 31% ns No adverse events have been reported. 21

22. Adherence Results Lab visit attendance: 5 � 1 out of 6 Home practice: 22 � 5 days out of 36 iMINDr-8 ppts; subjective 522 min �162; objective 472 min �134; .88 correlation 22

23. Thank you! Jennifer Bishop Roger Ellingson Wyatt Webb Irina Fonareva Elena Goodrich Barry Oken NIH T32 AT002688, K01 AT004951, U19 AT002656 and UL1 RR024140 23

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