Objective adherence and study methods for VETMIND: A mindfulness meditation RCT for combat veterans...
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Objective adherence and study methods for VETMIND: A mindfulness meditation RCT for combat veterans with PTSD Helané Wahbeh, ND Assistant Professor Oregon
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
Slide 2
Brief background Vet Mind study methods Study progress
Objective adherence and iMINDr 2
Slide 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 Paying attention in a particular way, on purpose, in the
present moment, and non-judgmentally Jon Kabat-Zinn 3
Slide 4
Mindfulness Instruction and Practice Sitting Meditation Body
scan Mindfulness of daily activities Hatha Yoga 4
Slide 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
Slide 6
How is mindfulness eliciting clinical effects? Potential
mechanistic pathways Frontal Cortex Activity Autonomic Nervous
System Downstream (HPA) Mindfulness Slow Breathing Mindfulness and
Slow Breathing 6
Slide 7
Why PTSD? PTSD is a serious and costly health issue Combat
veterans are a rapidly growing group Pathophysiology reduces
ceiling effect 7
Slide 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
Slide 9
Trainings Mindfulness Meditation- Body Scan Slow Breathing
Mindfulness plus Slow Breathing Sitting Quietly 9
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
Slide 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 Wahbeh, H., Zwickey, H., Oken, B.
One method for objective adherence measurement in mind-body
medicine. J Altern Complement Med. 2011 Feb;17(2):175-7.
Slide 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 Carmody J, Baer RA. J Behav Med. 2008
Feb;31(1):23-33; Wahbeh H, The Open Complementary Medicine Journal.
2009;1:25-34; Sannes TS, J Altern Complement Med. 2008
Jul;14(6):645-53; Flegal KE, BMC Complement Altern Med. 2007 Nov
9;7(1):37; Osterberg L, N Engl J Med. 2005 Aug
4;353(5):487-97.
Slide 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
Slide 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
Slide 16
Objective Adherence: Take Two iMINDr-custom software
application developed with engineer for iTouch 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
Slide 17
Objective Adherence 17
Slide 18
Recruitment Telephone Screening 151 Consented/Screened 49
Randomized 41 Completed Study 33 Still in trainings 5
Excluded/Declined 102 Excluded/Declined 8 Withdrew 3 18
Slide 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 16: 13% 19
Slide 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
Slide 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. No adverse
events have been reported. 21
Slide 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
Slide 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
