Working with medically unexplained symptoms Professor Chris Williams University of Glasgow
Overview of session Why Cognitive Behavioural Therapy? Applying CBT to MUS Results of an RCT Working with processes that keep symptoms going/worsen things Resources and tools to widen access
Guided Self-Help For Functional ( Psychogenic ) Symptoms in neurological out-patients: A RCT Edinburgh: Michael Sharpe, Alan Carson, Jane Walker, Izzy Butcher, Gordon Murray, Jon Stone, Sharon Smith Glasgow: Chris Williams, Jonathan Cavanagh, Rod Duncan,
MUS in Neurology Patients Common: 1/3 new patient attenders have symptoms classified as not at all or somewhat explained by organic disease Chronic illness: Half report feeling the same or worse at 12 month follow-up
Guided Self-Help Intervention Support matters (NICE 2009, Gellatly et al 2007) Guidance: Maximum 4 sessions over 3 months CBT nurse therapist
Trial Design 130 neurology patients with medically unexplained symptoms 65 usual care 65 usual care + intervention
Sample Patients recruited from 2 centres over 1 year New (then all) outpatients attending general neurology outpatient clinics rated for organicity
To what extent can the patient s symptoms be explained by organic disease? Not at all Somewhat Largely Completely MUS
Sample Patients with symptoms rated not at all or somewhat explained then assessed for eligibility by a psychiatrist Exclusion criteria: Patient unable to participate in intervention significant cognitive impairment problems with written English Intervention not appropriate for patient s needs under 18 serious psychiatric illness or actively suicidal receiving psychiatric / psychological treatment presenting solely with chronic daily headache
Measures Primary Outcome: CGI (Clinical Global Improvement Scale) at 3 months Secondary Outcomes: Change in presenting symptoms (Likert scale) Total symptom burden Physical function (SF-12 subscale) HADS-depression HADS-anxiety
CGI- We would like you to think about the past few months, since your first appointment at the Neurology Outpatient Clinic. Please indicate how your health compares with the time that you first attended the neurology clinic? Much worse Worse Have not changed Better Much better Your general health o o o o o The symptoms for which you came to the clinic o o o o o
Recruitment 3056 rated for organicity 365 excluded: 126 refused 239 did not meet inclusion criteria 492 Symptoms Not at all / Somewhat explained 2564 Symptoms completely / largely explained 127 randomised 63 assigned to Usual Care 64 assigned to Usual Care + Intervention 62 received intervention 0 lost to follow up at 3 months 2 lost to follow up at 3 months 63 included in 3 month analysis 62 included in 3 month analysis
Characteristics of the Sample Variable N=127 Age Mean (SD) 42.5 (11.7) Sex Male 37 (29%) Marital status Married / partner 68 (54%) Single 34 (27%) Divorced / separated 25 (20%) Employment Working 69 (54%) Not working (health) 56 (44%) Not working (other) 2 (2%) Symptom duration < 1 year 28 (22%) 1-5 years 62 (49%) >5 years 37 (29%)
Characteristics of the Sample Variable N=127 Symptom Burden HADSdepression HADSanxiety SF12 physical function Panic disorder Mean (SD) number of symptoms 14.1 (5.8) Mean (SD) 6.6 (4.4) Mean (SD) 8.4 (4.4) Mean (SD) 51.8 (38.1) All diagnosed 82 (65%) With agoraphobia 7 (6%) GAD 48 (38%) MDD 24 (19%)
Characteristics of the Sample Top Ten Symptoms: Paralysis or weakness of an arm or leg Pain in arms, legs or joints Lack of co-ordination or balance Dizziness Headaches Problems with memory or concentration Loss of sensation, numbness or tingling Nausea, gas or indigestion Feeling tired or having low energy Trouble sleeping
Adherence to Treatment 62/64 (97%) patients received at least 1 session of support Average number of guidance sessions: 3 (range 0-4) Average duration of guidance sessions: 30 mins All guidance sessions recorded and rated independently for adherence to treatment protocol: 23/25 (92%) adhered
Primary Outcome: CGI at 3 months 40 35 30 25 20 usual care usual care+intervention 15 10 5 0 much worse worse not changed better much better
Primary Outcome: CGI at 3 months Usual Care (n= 63) Usual Care + Intervention (n=64) Intervention effect (95% CI) P value N Mean (95% CI) N Mean (95% CI) 63 2.9 (2.6, 3.1) 62 3.2 (3.0, 3.4) 0.35 (0.08, 0.63) 0.013
Secondary Outcomes Variable Usual Care (n= 63) Usual Care + Intervention (n=64) Difference P- value Change in presenting symptoms (adjusted for organicity and centre) N=63 2.9 (2.7, 3.1) N=62 3.3 (3.1, 3.5) 0.40 (0.10, 0.71) 0.010 Change in symptom burden from baseline N=62-0.6 (-1.7, 0.4) N=61-2.7 (-3.7, -1.7) -2.08 (-3.51, -0.65) 0.005 HADS depression (adjusted for baseline) N=61 7.1 (6.3, 7.8) N=61 6.3 (5.5, 7.0) -0.79 (-1.85, 0.26) 0.139 HADS anxiety (adjusted for baseline) N=61 8.4 (7.5, 9.3) N=61 7.3 (6.4, 8.2) -1.12 (-2.36, 0.12) 0.077 SF12 Physical Function (adjusted for baseline) N=62 53.6 (48.0, 59.2) N=60 57.5 (51.8, 63.2) 3.88 (-4.15, 11.91) 0.340
Sustainability of treatment effect at 6 months 35 30 25 20 15 usual care usual care+intervention 10 5 0 much worse worse not changed better much better
Sustainability of treatment effect CGI (at 3 and 6 months): treatment effect is sustained (P=0.019) At 6 months: Change in presenting symptoms: still significantly better (P=0.018) Change in symptom burden: no longer significantly different HADS-depression: no difference (as at 3 months) HADS-anxiety: now significantly better (P=0.024) SF12 physical function: now significantly better (P=0.007)
Limitations Sample Exclusions by neurologists Symptom duration varied Intervention delivery: skilled CBT qualified nurse Self-rated primary outcome
Summary of Results Patients receiving usual care + Intervention had: Better outcomes on CGI & change in presenting symptoms at 3 & 6 months Less symptom burden at 3 months only Better anxiety & physical function scores at 6 months only
Does CBT work in functional disorders? (Functional disorder = Pain, weakness, dizziness etc. unexplained by organic disorder.) CBT can reduce the symptoms, distress and disability in patients with functional disorders = conclusion of review of RCT s (Kroenke K. (2007) Efficacy of treatment for somatoform disorder: a review of randomised controlled trials. Psychosomatic Medicine, 69, 881-888). But access to CBT is limited
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