A pragmatic, unblinded randomised controlled trial comparing an occupational therapy-led lifestyle approach and routine GP care for panic disorder treatment in primary care

Background: Treated anxiety increased in the UK by over 30% since 1994. Medication and psychological treatment is most common, but outcomes are sometimes poor, with high relapse rates. Lifestyle has a potential role in treatment, but is not considered in clinical guidelines. Panic disorder is potentially influenced by lifestyle factors. Methods: 16 week unblinded pragmatic randomised controlled trial in 15 East of England primary care practices (2 Primary Care Trusts). Participants met DSM-IV criteria for panic disorder with/without agoraphobia. Follow-up at 20 weeks and 10 months. Control arm, unrestricted routine GP care. Trial Arm, Occupational therapy-led lifestyle treatment comprising: lifestyle review of fluid intake, diet pattern, exercise, caffeine, alcohol and nicotine; negotiation of positive lifestyle changes; monitoring and review of impact of changes. Primary outcome measure: Beck Anxiety Inventory. Data analysis: Intention-to-treat analysis provided between-group comparisons using analysis of co-variance. Bonferroni method to adjust p-values. Results: From 199 referrals, 36 GP care and 31 lifestyle arm patients completed to final follow-up. Significantly lower lifestyle arm BAI scores at 20 weeks (p < 0.001), non-significant (p = 0.167) at 10 months after Bonferroni correction. 63.6% lifestyle arm, and 40% GP arm patients (p = 0.045) panic-free at 20 weeks; 67.7% and 48.5% (p = 0.123) respectively at 10 months. Limitations: Final study size/power calls for caution in interpreting findings. Conclusions: A lifestyle approach may provide a clinically effective intervention at least as effective as routine GP care, with significant improvements in anxiety compared with routine GP care at the end of treatment. Further study is required before suggesting practice changes. (c) 2006 Elsevier B.V. All rights reserved.