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

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

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

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

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)

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)

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

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 74156610

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.

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

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

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

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.

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)

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

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

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)

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

We were unable to test any mediation model

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?

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

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