Unwanted or negative treatment reactions in digital psychological interventions for adolescents with chronic pain.

Objective: Reports of pain clinical trials evaluating psychological treatments often lack sufficient details on the potential and actual harm resulting from intervention. We aimed to understand how frequent and intense treatment reactions, conceptualized as unwanted symptoms, were in three clinical trials of digital Cognitive Behavioral Therapy (CBT) for adolescents with: (1) chronic primary pain, (2) sickle cell disease, and (3) chronic pancreatitis. We also aimed to understand any differences by demographic and clinical variables.

Method: Analyses were conducted with 246 youths (12-18 years old) experiencing chronic pain and one of their caregivers. 66% of the total sample was female. The number, intensity, and type of treatment reactions experienced were assessed post treatment. T-tests and Chi-squared tests were conducted to explore whether certain treatment reactions were more frequent as a function of baseline or clinical characteristics.

Results: 9% of participants experienced some negative treatment reaction. The average intensity of those events was very low on a 0-3 scale (M = 0.1, SD = 0.4). There were no differences in the prevalence or intensity as a function of participant's sex, age, race, or baseline pain intensity. However, baseline anxiety [t = -2.4 (244); p < .05] and baseline pain interference [t = -2.2 (223); p < .05] were significantly higher in those who experienced negative treatment reactions.

Conclusions: A small number of participants reported experiencing negative treatment reactions, with a low intensity level. Those experiencing negative treatment reactions showed higher baseline anxiety and pain interference. Future research may build from our example to standardize collection of harms data in trials of psychological interventions.