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) primary pain, (2) sickle cell, and (3) chronic pancreatitis. We also
aimed to understand any differences by demographic and clinical variables.
Method: Analyses were conducted with 246 youth (12-18 years old) experiencing
chronic pain and one of their caregivers. Sixty-six percent of the total sample was female.
The number, intensity and type of treatment reactions experienced was assessed at posttreatment. T-tests and Chi-Squares were conducted to explore whether certain treatment
reactions were more frequent as a function of baseline or clinical characteristics.
Results: Nine percent of participants experienced some negative treatment reaction. The
average intensity of those events was very low on a 0 to 3 scale (M=0.1, SD=0.4). There
were no differences in prevalence or intensity as a function of participant’s sex, age, race
or baseline pain intensity. However, baseline anxiety (t=-2.4 (244); P<0.05) and baseline
pain interference (t=-2.2 (223); P<0.05) 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.
