Evidence map›Paper›PMID 39679534›Full record

ArticleJournal of pediatric psychology2025

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

Rocío de la Vega, Kaylee Yokoyama, Kristen Daniels, Tonya M Palermo

Abstract read
In one paragraph

Article in Journal of pediatric psychology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Rocío de la VegaDepartment of Personality, Assessment, and Psychological Treatment, Faculty of Psychology and Speech Therapy, University of Málaga, Málaga, Spain.ORCID 0000-0002-2517-6948
Kaylee YokoyamaCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Kristen DanielsCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.
Tonya M PalermoCenter for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, WA, United States.ORCID 0000-0001-6036-6715

Funding

Year 9 Administrative Supplement to INSPPIRE 2U01DK108334 · NIDDK · UNIVERSITY OF IOWA · PI MARK E. LOWE, Aliye Uc · 2015 to 2026
$10.5M
A Randomized Trial of a Web-based Non-Pharmacological Pain Intervention for Pediatric Chronic PancreatitisR01DK118752 · NIDDK · UNIVERSITY OF IOWA · PI PALERMO, TONYA M, UC, ALIYE · 2018 to 2022
$3.0M
iCanCope with Sickle Cell DiseaseR01HD086978 · NICHD · SEATTLE CHILDREN'S HOSPITAL · PI DAMPIER, CARLTON, PALERMO, TONYA M · 2016 to 2020
$2.4M
Role of sleep deficiency in self-management of pediatric chronic painR21NR017312 · NINR · SEATTLE CHILDREN'S HOSPITAL · PI PALERMO, TONYA M · 2018 to 2019
$427k
Eunice Kennedy Shriver National Institute of Child Health and Human DevelopmentNICHD NIH HHS R01 HD086978NIDDK NIH HHS R01 DK118752NIDDK NIH HHS R01DK118752NIDDK NIH HHS U01 DK108334NIH HHSNIH HHS R01HD086978NINR NIH HHS R21 NR017312Spanish Ministry of Science and Innovation RYC2018-024722-I
6 · The paper itself

Abstract

objectiveReports 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.

methodAnalyses 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.

results9% 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.

conclusionsA 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.

Indexed as

Anemia, Sickle CellChronic PainCognitive Behavioral TherapyPancreatitis, ChronicAdolescentAnxietyChildFemaleHumansMaleAdverse Eventsharmspediatric painpsychological interventionstreatment reactions

Identifiers

PMID39679534
PMCPMC12448297

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.