Background & Aims

Reports of pain clinical trials evaluating psychological treatments, often lack sufficient details on the potential and actual harm resulting from intervention [5]. This is partly due to the lack of regulations, guidelines, and well-established definitions of unwanted events and reactions associated with such interventions [3]. This is even more concerning when trials are conducted with vulnerable populations, such as children, or in the case of self-guided digital interventions, where there is often no direct contact with participants [2]. Consequently, little is known about the frequency of such reactions and whether they are related to participants’ characteristics. We aimed to test a self-report assessment tool to understand how frequent and intense treatment reactions were in 3 clinical trials of digital interventions 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

Methods

Analyses were conducted with data from 3 randomized controlled trials of digital Cognitive Behavioral Therapy (CBT) for youth (12-18 years old) experiencing chronic pain. Sample 1 comprised mostly White youth with primary chronic pain (n = 85), Sample 2 consisted of mostly Black youth with sickle cell pain (n = 111), and Sample 3 included mostly White youth with chronic pancreatitis (n = 90). Sixty-five percent of the total sample was female. The number, intensity and type of treatment reactions experienced was assessed at post-treatment using a questionnaire developed for the study (asking about anxiety or tension at home). Baseline pain intensity was assessed with a 0-10 Numerical Rating Scale, pain interference was assessed with the CALI-9 [1], and anxiety was assessed using the PROMIS pediatric Anxiety 8a scale [4]. 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

Of the 276 participants that provided post-treatment data, 23 (8.3%) experienced some type of negative treatment reaction. The average intensity of those events, in a 0 (“did not affect me at all”) to 3 (“affected me very negatively”) scale, was 1.4 (SD = 0.7). There were no significant differences in experienced treatment reactions as a function of participant’s sex, age or race. Negative treatment reactions were not different based on baseline pain intensity. However, baseline anxiety was significantly higher in those who experienced negative treatment reactions (t = -2.4 (244); P < 0.05) and baseline pain interference was higher in that group as well (t = -2.2 (223); P < 0.05) compared to those who did not experience negative treatment reactions.

Conclusions

In conclusion, among the included youth with chronic pain, a small number (8.3%) reported experiencing negative treatment reactions, with a low intensity level and most commonly increased anxiety. Interestingly, no significant differences in treatment reactions were observed based on participants’ sex, age, or race. However, we found that those experiencing negative treatment reactions showed higher baseline anxiety and increased pain interference. These findings underscore the importance of considering baseline psychological factors in delivering psychological interventions in a safe and effective manner, highlighting potential areas for targeted intervention and personalized care.
Systematically assessing treatment reactions will facilitate making informed clinical decisions by weighing benefits and risks, influencing healthcare policies, and fostering the understanding of treatment mechanisms, including potential moderating or mediating effects of negative treatment reactions.

References

[1] Holley AL, Zhou C, Wilson AC, Hainsworth K, Palermo TM. The CALI-9: A brief measure for assessing activity limitations in children and adolescents with chronic pain. Pain 2017. doi:10.1097/j.pain.0000000000001063.
[2] de la Vega R, Palermo TM. Assessing and Reporting Treatment Reactions and Adverse Events in Psychological Interventions and Clinical Trials: Current Challenges and Guidelines for Good Practice. Reference Module in Neuroscience and Biobehavioral Psychology. Elsevier, 2020. doi:10.1016/B978-0-12-818697-8.00051-0.
[3] Linden M. How to define, find and classify side effects in psychotherapy: From unwanted events to adverse treatment reactions. Clin Psychol Psychother 2013;20:286–296. doi:10.1002/cpp.1765.
[4] Northwestern University. PROMIS Scoring Manuals. n.d. Available: https://www.healthmeasures.net/promis-scoring-manuals.
[5] Palermo TM, Slack K, Loren D, Eccleston C, Jamison RN. Measuring and reporting adverse events in clinical trials of psychological treatments for chronic pain. Pain 2020;161:713–717. doi:10.1097/j.pain.0000000000001772.

Presenting Author

Rocío de la Vega

Poster Authors

Rocío De la Vega, Ph.D.

PhD

University of Málaga

Lead Author

Kristen Daniels

MsC

Seattle Children's Research Institute

Lead Author

Tonya Palermo

Tonya Palermo

Lead Author

Topics

  • Pain in Special Populations: Adolescents