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Research report
School of Allied Health Professions, University of East Anglia, Norwich, Norfolk, England, NR4 7TJ, UK
b
School of Medicine, Health Policy and Practice, University of East Anglia, Norwich, UK
c
School of Allied Health Professions, University of East Anglia, Norwich, UK
Received 19 June 2006; received in revised form 8 August 2006; accepted 11 August 2006
Available online 2 October 2006
Abstract
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 b 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.
2006 Elsevier B.V. All rights reserved.
Keywords: Clinical trial; Panic disorder; Lifestyle; Primary care; Occupational therapy; Pragmatic
The main results from this research were presented at the 33rd
North American Primary Care Research Group Meeting held in
Quebec City on October 15th18th 2005.
Corresponding author. Tel.: +44 1603 593096; fax: +44 1603 593166.
E-mail address: r.lambert@uea.ac.uk (R.A. Lambert).
1
Clinical Trial Registration details: Controlled-trials.com
ISRCTN51562655 http://www.controlled-trials.com/isrctn/search.asp.
0165-0327/$ - see front matter 2006 Elsevier B.V. All rights reserved.
doi:10.1016/j.jad.2006.08.026
1. Introduction
In England, the cost of mental illness is estimated at
over 77 billion, including the costs of care provided by
the NHS, local authorities, privately funded services,
family and friends; lost output in the economy caused by
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Table 1
Baseline demographic and clinical characteristics
Lifestyle arm
N
Gender (female)
Age
No. of children
Mean
68.4
41/60
60
56
38.6
1.3
S.D.
Mean
3.0
2.0
2.7
1.0
46
59
2.8
1.5
3.0
1.0
1.9
0.9
7.4
15.6
5.5
5.9
29.5
24.3
5.0
8.0
6.0
6.0
29.0
23.5
6.4
19.5
2.1
1.9
11.3
10.5
59
56
59
58
58
58
8.5
8.7
5.4
5.1
29.4
23.1
5.0
6.0
6.0
5.0
27.0
23.0
9.0
10.3
2.3
1.7
13.5
12.3
54
54
21.1
61.4
22.0
59.5
8.2
23.1
57
57
21.8
61.8
22.0
62.0
8.1
24.9
54
54
53
54
54
53
53
54
82.2
60.2
41.6
53.3
32.8
59.7
25.2
42.2
90.0
75.0
42.0
52.0
30.0
62.5
0.0
42.0
19.8
40.8
10.1
15.4
19.0
24.2
33.9
15.1
59
59
59
57
59
59
59
59
80.5
59.3
43.0
54.5
36.5
60.8
36.2
45.3
90.0
75.0
44.0
57.0
35.0
62.5
33.3
48.0
23.6
41.5
10.0
17.6
20.6
28.9
40.7
17.7
53
53
0.6
60.8
0.7
60.0
0.3
18.8
59
58
0.7
64.2
0.8
67.5
0.2
18.1
52
54
54
54
53
54
52
52
4.1
2.1
1.5
1.6
1.0
2.4
9.3
12.8
2.0
2.0
1.0
2.0
1.0
2.0
9.0
13.0
4.1
1.7
1.2
1.3
0.9
1.3
51.0
5.0
58
58
58
58
58
58
58
58
4.0
2.2
1.6
1.7
0.8
2.0
9.4
12.3
1.0
2.0
1.0
2.0
1.0
2.0
8.0
10.5
43.0
1.7
1.5
1.5
0.7
1.4
6.3
7.1
39/57
57
55
40.1
1.7
Mean
39
54
3.4
1.7
55
52
55
55
54
54
Median
Mean
%
68.3
Median
S.D.
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Fig. 2. Lifestyle arm paired t-test for lifestyle behaviour index (Baselineassessment period).
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Fig. 4. Difference in BAI total score between baseline and end of treatment and baseline and follow-up.
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