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High Intensity Comparators: Active Psychotherapy

High Intensity Comparators: Active Psychotherapy. Denise E. Wilfley, Andrea E. Kass, & Rachel P. Kolko Department of Psychiatry Washington University School of Medicine. Friday, June 24 th , 2011. R29MH051384; R01MH064153; K24MH070446; T32HL00745626. Disclosures. Research Support

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High Intensity Comparators: Active Psychotherapy

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  1. High Intensity Comparators: Active Psychotherapy Denise E. Wilfley, Andrea E. Kass, & Rachel P. Kolko Department of Psychiatry Washington University School of Medicine Friday, June 24th, 2011 R29MH051384; R01MH064153; K24MH070446; T32HL00745626

  2. Disclosures • Research Support • Shire Pharmaceuticals • Advisory/Consultant • GlaxoSmithKline Consumer Healthcare • Minnesota Obesity Consortium • United Health Group, Childhood Obesity Initiative • Wellspring Healthy Living Academy

  3. Competing Treatments: Going Head to Head

  4. Overview • Present an evolution of treatment research evaluating high-intensity, active comparators in contrast to IPT in the treatment of binge eating

  5. Rationale for Selecting an Active Comparator • To contrast two or more conceptually-competing interventions • To evaluate the varied effects of different treatments • Short- and long-term efficacy • To examine moderators and mediators of treatment outcome

  6. RCT #1: Initial Efficacy Study Comparison of IPT, CBT, and WL Control • Investigate whether IPT is as effective as CBT (“gold-standard”) for the treatment of recurrent binge eating • Distinguish specificity between two models of symptom maintenance • Test the applicability of results from a separate study team (Fairburn et al., 1991) in a different population • Design:56 women randomized to IPT, CBT, or WL control Wilfley et al. (1993 ), J Clin Consult Psychiatry

  7. Comparison of IPT, CBT, and WL Control: Results • Results support the efficacy of IPT for binge eating • No differential active treatment effects • Similar to previous findings (Fairburn et al., 1991) WL vs. CBT: d = 0.82 WL vs. IPT: d = 1.47 CBT vs. IPT: d = 0.38 Group X Time Interaction: p<0.003 Wilfley et al. (1993 ), J Clin Consult Psychiatry

  8. Lingering Questions from the Initial Efficacy Comparison Trial • Is equivalency due to weak power (small sample size)? • Were the assessment measures unreliable?

  9. RCT #2: Large-Scale Comparison of IPT and CBT • Compare short and long-term treatment effectiveness within a large sample (N=162) using state-of-the-art measures • Evaluate both treatment effectiveness and scope of outcome effects • Assess mode specificity • Identify mechanisms of effect and predictors of outcome • Examine time course of changes in outcome • Will lead to more efficient and effective treatments and provide information about treatment matching • Evaluate reliability of prior findings (Wilfley et al., 1993) Wilfley et al. (2002), Arch Gen Psychiatry

  10. Large-Scale Comparison of IPT and CBT:Design Considerations • Theory and empirical findings suggest IPT and CBT are ideal for comparison ensure specificity of effects • Differ markedly on specific aspects (i.e., theories, assumptions, and procedures) • Comparable on many nonspecific elements (e.g., credibility to patients, duration, therapist attention) • No WL control condition • CBT and IPT have demonstrated superiority to WL condition • No scientific, ethical, or clinical reason to include • No placebo psychotherapy condition • Sufficient power to detect differences between CBT and IPT; less cost to implement Wilfley et al. (2002), Arch Gen Psychiatry

  11. RCT #2: Large-Scale Comparison of IPT and CBT • Recovery rates: • Equivalent • Specificity of effects: • Differential time course for reductions in dietary restraint • Treatment integrity: • 100% rater accuracy for modality • Significantly differentiated treatment-specific indices • Patient confidence in treatment: • Equivalent • Dropout, compliance, or completion of follow-up: • Equivalent Wilfley et al. (2002), Arch Gen Psychiatry

  12. RCT #3: Comparison of IPT, BWL, and CBT-GSH • Research Question:Do patients with BED require specialty treatments? • Investigate the long-term effectiveness of three treatments for BED • Test differential efficacy across levels of negative affect (moderator) • Examine mechanisms of therapeutic change • Assess therapist and therapy variables • Design: 205 women and men across three sites • Includes largest sample size to date, valid measurement of binge eating, and long-term follow-up • Evaluates generalizability by testing across sites Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry

  13. Rationale for the Treatment Approaches • IPT: Specialty treatment • Addresses negative affect (moderator analysis) • May be highly acceptable to the majority of practicing therapists • BWL:Nonspecialty treatment • Does not specifically target binge eating • More easily disseminable than IPT; requires less intensive training and therapeutic expertise • CBT-GSH:Minimal treatment effectiveness comparison • Controls for many of the nonspecific influences that affect outcome • Less costly and more disseminable than BWL Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry

  14. Differential Treatment Outcomes for Dietary Restraint F(1,193) = 5.3 p=.006 BWL > GSH Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry

  15. RCT #3: Comparison of IPT, BWL, and CBT-GSH • Recovery rates: • IPT and CBT-GSH > BWL • Patient report of suitability: • IPT significantly more suitable • Dropout: • IPT significantly lower rate • Treatment Allegiances:* • No evidence of “allegiance bias” – no differential site X treatment effects • No individual therapist effects emerged in IPT or CBT-GSH BWL vs. CBT-GSH: OR = 2.3* BWL vs. IPT: OR = 2.6* CBT-GSH vs. IPT: OR = 1.2 *p<0.05 Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry *Wilson, Wilfley, Agras, & Bryson (2011), ClinPsycholSciPrac

  16. Moderators at 2-year Follow-up • Global EDE, W(1) = 4.4, p < .036 • Self-esteem, W(1) = 4.6, p < 0.032 Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry

  17. Remission Rates: Low Self-Esteem and Global Eating Pathology Wilson, Wilfley, Agras, & Bryson (2010), Arch Gen Psychiatry

  18. Summary • IPT is an efficacious treatment for binge eating disorder • Using high-intensity comparators demonstrates treatment efficacy • Enhances ability to detect treatment matching and specificity of effects • Important considerations: • Interpretation of effect sizes: likely to yield minimal differences • Rests on strict adherence to protocol

  19. Future Directions • Design considerations: • Tests of non-inferiority, equivalence, and superiority • Patient-centered outcome research • Assessing for patient preference and satisfaction throughout treatment research process • Dissemination and implementation science research

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