1. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP A pragmatic unblinded randomised controlled trial and economic evaluation of an occupational therapy-led lifestyle approach and routine GP care of the treatment of Panic Disorder presenting in primary care AM P pproach toanicifestyle L anaging by Rod Lambert, Ian Harvey and Fiona Poland

2. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Supported by: NHS R&D Primary Care Researcher Development Award Fellowship National Coordinating Centre for Research Capacity Development And NHS R&D Eastern Region, Health Services and Public Health Research Scheme Grant

3. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Background Prevalence Altered Sensitivities Misinterpretation of bodily sensation Lifestyle influences

4. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Inclusion/exclusion Age range 18-65 years Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) Stable medication

5. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Similar baseline profiles in each arm Baseline comparisons LifestyleGP Care Mean Beck Anxiety Inventory29.529.4 Beck Depression Inventory24.323.1 Fear Questionnaire61.461.8 Lifestyle Behaviour Index LBI General fluid2.42.0 LBI Caffeine1.00.8 LBI Diet1.61.7 LBI Physical exercise1.51.6 LBI Alcohol2.12.2 LBI Smoking4.14.0 EQ-5D EuroQol EQ-5D Anxiety/depression2.12.0 EQ-5D Pain/discomfort1.5 EQ-5D Usual activities1.41.5 EQ-5D Self-care1.0 EQ-5D Mobility1.2 EQ-5D EuroQol: Health valuation/10060.864.2 Number of full panic attacks/last month7.48.5 No of GP Practice appointments in last 3 months3.42.8 Lifestyle Arm GP Care Arm Gender Male1831.6%1931.7% Female3968.4%4168.3% Age40.1 38.6

6. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Lifestyle approach Up to 10 treatment sessions (total 7 hours) over 16 weeks Gradual tapering of treatments to minimise dependence 4 stages – 1. Lifestyle review (Self-report lifestyle and mood diaries) 2. Educational component 3. Negotiated lifestyle change 4. Monitoring and review Routine GP care Monitored, but unrestricted.

7. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Intended vs Actual study size 31 Lifestyle arm 36 GP Care arm

8. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP P<0.001P= 0.167 BAI LS GP Base 29.5 29.4 20w 9.2 17.2 10 m 13.3 16.4 Favours GP arm Favours Lifestyle arm ANCOVA for results of BAI showing mean difference and 95% CI’s

9. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP

10. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Scatterplots of the relationship between LBI Original Total score and BAI Total score at baseline, 20 weeks and 10 month follow-ups GP arm Lifestyle arm Total population BAI Total score LBI Original Total score Baseline Pearsons R=0.243 p=0.005 20 weeks R=0.386 p=0.001 10 months R=0.1 p=0.431

11. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP

12. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Economic evaluation From the perspective of the health care provider (GP practice) Cost-effectiveness analysis Incremental cost-effectiveness ratio

13. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP The Cost-Effectiveness plane Increased costs Decreased costs Improved outcomes Worse outcomes 4. Trial treatment dominates with improved outcome and lower cost 1. Trial treatment has worse outcome and higher cost 3. Trial treatment has improved outcome but higher cost Costs may outweigh benefits 2. Trial treatment has worse outcome but lower cost Worse outcome may outweigh lower cost

14. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP The Cost-Effectiveness plane for the BAI of a Lifestyle approach to the treatment of Panic Disorder compared with Routine GP Care between baseline and 20 weeks, and baseline and 10 months £50 0 £100 £150 £200 £250 -£250 -£200 -£150 -£100 -£50 -£300 £300 Effects 1 23456 -6 -5-4-3-2 78 -8-7 BAI ICER Baseline to 10 months - 48.51/-3.71 = -13.08 BAI ICER Baseline to 20 weeks 270.95/-8.43 = 32.14 Higher lifestyle arm cost Lower lifestyle arm cost

15. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Conclusions The study procedures provided equivalent groups at baseline. A relationship between lifestyle and anxiety was observed. After Bonferroni correction, significant between-group differences were observed using the primary outcome measure (BAI) at 20 weeks, but not 10-months. Nearly 8 times more GP care arm patients than lifestyle arm patients reported negative BAI changes. Just under 70% of lifestyle arm patients were panic-free at 10 months compared with just under 50% in the GP care arm. The lifestyle intervention provided non-significant cost savings and improved clinical outcomes compared with routine GP care.

16. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP Implications for Research and Practice Implications for Primary Care - Lifestyle review can identify factors that influence anxiety - More research is required to establish a more standardised assessment for lifestyle review - Individual and group applications of the lifestyle approach with patients with anxiety conditions requires further examination Implications for Panic Disorder - The findings indicate another potentially cost-effective treatment - Complex relationships have been identified in the potential genesis and maintenance of panic. These relationships appear to be additive and involve genetic predisposition, neurotransmitter systems and body systems, cognitive and memory systems and environmental factors and life events. More research is required to explore these relationships. - A larger, multi-centre trial of the lifestyle approach is required to obtain greater statistical power and reliability

17. School of Allied Health Professions & School of Medicine, Health Policy & Practice LAMP