1. Illness cognitions and socialization to the treatment model: Mechanisms of change in an RCT for the treatment of CFS/ME
Jo Roos
2gether NHS Foundation Trust, Gloucestershire
Alison Wearden
School of Psychological Sciences University of Manchester

2. Chronic Fatigue Syndrome/ME
Principal complaint of severe fatigue, lasting at least 6 months
Unexplained by medical or psychiatric conditions
Fluctuating symptoms, may be unpredictable
Diagnosis by history and exclusion
Patients may feel disbelieved
Substantial disability, health care and economic costs
Condition remains poorly understood

3. Illness cognitions in CFS/ME
Common patterns of illness cognitions
Strong illness identity
Chronic timeline
Severe consequences
Little control over illness
Somatic cause
Predictors of outcome
Perceived low levels of control
Attributing to CFS/ME to physical cause
CFS/ME chronic condition
Symptom focus
Only two studies reporting on change

4. So what changes when people get better?
Are there changes in beliefs about illness?
Change in personal control over illness associated
with better outcomes?
Is there a change in symptom focusing?
Reduction in symptom focusing mediated
improvement in exercise therapy study (Moss-Morris et al., 2005)
Does this relate to change in understanding
of CFS/ME through treatment?
Socialization to the model

5. Socialization to the model
Socialization increases likely benefit from therapy (Orne & Wender, 1968)
Importance of socialization recognised
(Beck, 1995; Wells 1997)
Outlined as intergral part of therapy in clinical manuals (Westbrook et al. 2007; Wells 2007)
Evolving collaborative conceptualization
serves key functions in therapy to achieve
goals (Kuyken et al. 2010)

6. What is socialization to the model?
“ The process by which a shared understanding is negotiated between patient and clinician. Clinician presents a hypothesis and a formulation of the patients symptoms and experience in terms of the model to be used for intervention.
The clinician provides information concerning the practical implications of the chosen model to allow the patient to fully engage with and understand both the therapeutic process and the rationale for the intervention”
(Roos & Wearden, 2009)

7. Study Hypotheses Socialization to the treatment model Reduced fatigue
Improved functioning
(Change in activity)
Increased personal control
Decreased symptom focussing

8. Fatigue Intervention by Nurse Evaluation (FINE)
Randomised Control Trial of treatments for
Chronic Fatigue Syndrome (CFS/ME)
(The FINE Trial; Wearden et al., 2010, BMJ)
Pragmatic
Rehabilitation (PR)
Supportive
Listening
Treatment as usual
by GP
Sub-study:
Mechanisms of change in the treatment of CFS/ME
ISRCTN

9. Pragmatic Rehabilitation (PR)
Model of physiological dysregulation provides
rationale for:
Program of graded return to activity
Regularization of sleep patterns
Relaxation address somatic symptoms of anxiety
Socialization process in PR:
Evidence-based model presented session 1
Collaborative development and implementation of
a tailored rehabilitation programme congruent
with the PR model
Enables patient to develop a coherent model of CFS/ME from which to base an intervention which follows from this model but is individually tailored.

10. Collaboratively agreed Rehabilitation plan
PR presentation
provides coherent
model of CFS/ME
Collaboratively agreed
Rehabilitation plan
Improved CV condition
Stronger muscles
Sleep regularised
Less anxious
Beliefs about meaning of
or focus on symptoms,
controllability of illness
Less fatigue and pain
Functioning improved
Behaviour change:
Implementing
rehabilitation plan
Effects of excessive rest in healthy individuals
Cardiovascular deconditioning
reduced exercise tolerance
muscle pain (may be delayed) on activity
weakness, dizziness, postural hypotension
changes to body temperature regulation
loss of concentration and motivation

11. Methods Participants all fulfilled Oxford CFS criteria*
50 patients allocated to pragmatic rehabilitation
Measures of socialization, personal control, symptom focusing
Derived from therapy tapes
First session after delivery of model
Last pre-discharge face-to-face therapy session
Relevant utterances extracted from tapes
and transcribed
*Sharpe et al, 1991

12. Outcomes Fatigue (Chalder fatigue scale; 0-33)
Physical functioning (SF-36; %)
Change calculated baseline (T1) to post-treatment (T2)

13. Developing the measures
Socialization to the model constructs derived
from a Delphi study (Roos & Wearden, 2009)
Count of utterances providing evidence of:
Concordance
Explicit understanding
Evidence of applying the principles
Active planning
Ratings combined into overall socialization
scale (alphas T1 = .72; T2 = .82)
Illness cognitions and socialization measured by extracting and coding utterances within the therapy tapes. Manual developed to code data derived from the recordings.

14. Measure of personal control over CFS/ME
Did the speaker believe that s/he could influence or change the expression or course of the illness?
Symptom focussing operationalised as count
of all mentions of own physical symptoms
Inter-rater reliability for both extraction of utterances and coding was satisfactory (kappas .79 to .92)

15. Summary of mediator measures
Socialization to the model at T1 and T2
Change in socialization to the model
Personal control at T1 and T2
Change in personal control
Symptom focussing at T1 and T2
Change in symptom focussing

16. Findings Scores on each variable at the two
time points highly correlated – we did not capture change
We were unable to show consistent associations between changes in variables.
Correlations between variables were
in expected directions

17. Change in socialization to the model was associated with change in perceived personal control (r=.420, p=.002)
Personal control at T2 associated with an improvement in physical functioning (r=.280, p=.049)

18. Socialization to the model at T2 associated with a reduction in fatigue scale scores (r=-.344, p=.015)
Symptom focussing was not related to either outcome

19. We were unable to test any mediation model

20. Summary and discussion (1)
Some findings consistent with hypotheses,
but some weak associations
Socialization to the model was associated
with reduced fatigue
Socialization in PR vs. CBT
Symptom focussing
Differences between study and Moss-Morris et al.
Problems with our measure?

21. Summary and discussion (2)
Strength of study that measures derived from what patient said during therapy
But measures difficult to derive and operationalise
Development of patient/therapist measure of socialization
CBT treatment trial, replicate findings
Median duratiob was 74 months, IQR 24, 111, maybe early intervention in CFS ME may be a better measure of the socialization to the model
Heterogenous clinical population - would work better with those say in panic disorder

22. The role of socialization in the CSM?
Coping procedures
(action plans)
Appraisal
Illness experience /
Somatic stimuli
Socialization process: integrating a coherent model of illness and plan of intervention
External information
e.g. television, friends’ experience,
Medical input
Interpretation of illness experience
Cognitive representation of illness
Illness identity–Timeline–Consequences–Cause-Control