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WHEN SOCIAL PSYCHOLOGY AND NEUROSCIENCE RESEARCH MERGE The case of PTSD

WHEN SOCIAL PSYCHOLOGY AND NEUROSCIENCE RESEARCH MERGE The case of PTSD. Julius Landwirth Yale Interdisciplinary Center for Bioethics. Emergence of PTSD. Wartime problem : Civil war-Korea Shell shock War neurosis Battle fatigue Symptoms thought to disappear after discharge

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WHEN SOCIAL PSYCHOLOGY AND NEUROSCIENCE RESEARCH MERGE The case of PTSD

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  1. WHEN SOCIAL PSYCHOLOGY AND NEUROSCIENCE RESEARCH MERGEThe case of PTSD Julius Landwirth Yale Interdisciplinary Center for Bioethics

  2. Emergence of PTSD Wartime problem : Civil war-Korea • Shell shock • War neurosis • Battle fatigue Symptoms thought to disappear after discharge Vietnam: Chronic mental health disease

  3. Diagnostic Criteria DSM-3 , 1980 (“Official disease”) Traumatic experience (not just war) Re-experience (nightmares,flashbacks) Avoidance (of topic,of people) Hyper-arousal (startle, poor sleep,memory,concentration)

  4. Research impact: International Society for Traumatic Stress Studies Journal of Traumatic Stress

  5. Current criteria • DSM-4-TR (2000) Intrusive recollection (dreams, flashes) Avoidance/numbing (memory, concentration, disinterest,detachment) Hyper-arousal (sleep, outbursts, startle, hyper-vigilance) Duration ( > 1 month) Functional significance

  6. “Conceptual bracket creep” ? Criterion A: Stressor “ The person has experienced, witnessed, or been confronted with an event or events that involve actual or threatened death or serious injury, or a threat to the physical integrity of oneself or others” Disease vs medicalization of normal distress reactions ?

  7. Epidemiology/public health Combat veterans ( Iraq, Afghanistan): Health surveys of 88,235 active and reserve soldiers, upon deployment and 3-6 months later. PTSD symptoms increased 11.8-16.7% in active group 12.7-24.5% in reserve group Milliken CS, et al. JAMA 2007 ;298:2141-2148 ************ VA cost for PTSD: $4.3 billion in 2004

  8. Epidemiology/public health General Public - About 7% may develop PTSD during lifetime - 20 years of active symptoms - 1 day/week work impairment - 19 % suicide risk - $3 billion annual productivity loss Cited in Kolber AM, Vanderbilt Law Review 2006;59:1561-1625

  9. Emotionally charged memories Hippocampus, amygdala Consolidation, re-consolidation Hypothalamic-pituitary-adrenal axis

  10. “ Each time you retrieve a memory it must be restored. When you activate a memory in the presence of a drug that prevents the storage of the memory, the next day the memory is not as accessible” Joseph LeDoux, NYU neuroscientist

  11. The Quest to Forget R.A. Henig, NY Times, April 4, 2004 A Pill to fade traumatic memories ? Doctors are working on it M. Marchione, Assoc Press, Jan 14, 2006

  12. Research on humans 37 people received either drug (propanolol) or placebo prior to stimulus exposure Slides telling 2 stories: 1) Boy on way to hospital to visit father sees car accident. Sees ER drill 2) Boy injured, ER works on shattered legs

  13. Results 1 week later, subjects asked to recall details, also measured heart rates In story # 1 (non-arousal), no difference In story #2 (arousal), those on placebo remembered gory details, faster heart rate (facts of stories not changed)

  14. Ethical issues Treating 100% within 6 hours to prevent 30% Presidents Commission on Bioethics (2003) - may interfere with coming to terms with trauma - tampering with identity; false sense of happiness - demeans genuinness of human life experience

  15. Ethical issues - forgetting events we are obliged to remember - inure us against pain of others

  16. Legal issues • Tampering with socially valuable information ( evidence) • Mitigation of emotional injury damages

  17. Research ethics concerns • Vulnerability • Informed consent • Psychological challenge study - How to justify enrolling participants into study in which potentially harmful response is intentionally induced

  18. APA Task Force on Research Ethics ( 2006) “ Research strategies that may prolong or exacerbate symptoms can be justified when practicable alternative research strategies have been carefully considered and found scientifically inadequate and when clear plans are developed to minimize negative effects and to ensure the safety of research participants “

  19. Which means… • Prelim data • Screening for susceptability • Potential for minor injury • Potential for transient injury • Availability of treatment • Withdrawal from study • Monitor for fluctuating cognition - etc

  20. Questions to ponder What ethical issues might arise from the availability of drugs that can blunt traumatic memories ? What ethical issues might arise in the conduct of research testing such drugs on human subjects ?

  21. The EndThanks

  22. Case study The use of Propanolol to block memory reconsolidation in PTSD

  23. Research plan Participant recruitment flyer: “ Do you have upsetting memories from combat in Iraq or Afghanistan ? Male veterans from Operations OIF/OEF are needed for research using one day’s dose of a beta-block medication (propanolol) to see if it has an effect on upsetting combat memories. Payment up to $400 for a total of 4 visits”

  24. Study design 30 participants randomly assigned to 3 grps 1) Propanolol for traumatic memory;placebo for neutral 2) Placebo for traumatic memory;propanolol for neutral memory 3) Placebo for traumatic and neutral memory

  25. Research design Visit # 1: -Consent form -Screen for incl/excl (urine, cardiac, history, physical) -Standard questionnaires to confirm PTSD and severity –Audio-taped interviews (80 min) to ascertain neutral (daily life) and traumatic memory cues

  26. Research design Visit #2 ( first memory session): -Repeat drug screen -Attach psychophysio monitors (hr,skin conduct,facial emg), baseline recordings -30-sec neutral tape, 30-sec recall -40 mg Propanolol immediately, 60 mg 2 hrs later or placebo depending on group assignment

  27. Research design Visit # 3 (second memory session): -Same procedure using traumatic memory cues -Propanolol or placebo per group assignment

  28. Research design Visit # 4 ( 2 week follow-up) -Repeat drug screen -All groups hear their traumatic memory cue again -Standard questionnaire to assess change in PTSD symptoms

  29. Respect for persons social value scientific merit informed consent (ongoing) respect for participants

  30. Beneficence Favorable risk-benefit ratio Minimizing risk of harm Independent review

  31. Risk/benefit “ Participation in this study exposes the participants to greater than minimal risk….participants will contribute toward further understanding of the biological mechanisms underlying PTSD and its treatments….may benefit the individual…great benefit to society…risks posed by this study are reasonable when weighed against these potential contributions…”

  32. Minimizing risk “…risk associated with participation…will be minimized by close monitoring…the apprehension some individuals may feel during the memory reactivation test is slight and short-lived. Participants will be reminded that they can stop the study at any time’

  33. Justice Fair subject selection (military personnel ?)

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