Treatment Expectations and Pain-Related Outcomes in Clinical Trials of Digital Cognitive Behavioral Therapy for Youth with Chronic Pain.

Treatment expectations (TE) are predictive of patient outcomes in clinical practice and suggested to moderate treatment responses in chronic pain clinical trials. However, evidence is mainly derived from studies conducted with adult populations with musculoskeletal pain, primarily focused on pharmacological treatments and a few alternative intervention modalities (e.g., acupuncture). We examined the role of pretreatment TE in youth participating in two randomized controlled trials of digital cognitive-behavioral therapy (CBT) for chronic pain-the WebMAP2 Trial of youth with chronic primary pain (n = 273) and the iCC-SCD Trial of youth with sickle cell pain (n = 111). Specifically, we tested: 1) whether controlling for TE enhanced the detection of treatment efficacy, 2) the main effect of TE in predicting pain-related outcomes over time (regardless of treatment assignment), and 3) the effect of TE in moderating treatment efficacy (digital CBT vs education control). Findings indicated that adjusting for pretreatment TE did not enhance the ability to detect treatment efficacy. In the WebMAP2 Trial, higher pretreatment TE were associated with greater reductions in anxiety and lower CBT efficacy (relative to education control) in improving depressive and anxiety symptoms. In the iCC-SCD Trial, higher pretreatment TE were associated with greater improvement in mobility and enhanced CBT efficacy (relative to education control) for improving mobility. Overall, higher pretreatment TE were associated with better functioning over time, though the specific domains of improvement and the moderating effects on treatment efficacy somewhat differed between youth with primary and sickle cell-related chronic pain. PERSPECTIVE: Incorporating TE into clinical assessments and ensuring consistent collection, reporting, and analysis in clinical trials are crucial for identifying potential heterogeneous treatment responses. Standardizing TE measures for youth with chronic pain and considering population characteristics are important for understanding TE's role in treatment responses.