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Consensus statement on defining and measuring negative effects of Internet interventions
Open accessAbstract
Internet interventions have great potential for alleviating emotional distress, promoting mental health, and enhancing well-being. Numerous clinical trials have demonstrated their efficacy for a number of psychiatric conditions, and interventions delivered via the Internet will likely become a common alternative to face-to-face treatment. Meanwhile, research has paid little attention to the negative effects associated with treatment, warranting further investigation of the possibility that some patients might deteriorate or encounter adverse events despite receiving best available care. Evidence from research of face-to-face treatment suggests that negative effects afflict 5–10% of all patients undergoing treatment in terms of deterioration. However, there is currently a lack of consensus on how to define and measure negative effects in psychotherapy research in general, leaving researchers without practical guidelines for monitoring and reporting negative effects in clinical trials. The current paper therefore seeks to provide recommendations that could promote the study of negative effects in Internet interventions with the aim of increasing the knowledge of its occurrence and characteristics. Ten leading experts in the field of Internet interventions were invited to participate and share their perspective on how to explore negative effects, using the Delphi technique to facilitate a dialog and reach an agreement. The authors discuss the importance of conducting research on negative effects in order to further the understanding of its incidence and different features. Suggestions on how to classify and measure negative effects in Internet interventions are proposed, involving methods from both quantitative and qualitative research. Potential mechanisms underlying negative effects are also discussed, differentiating common factors shared with face-to-face treatments from those unique to treatments delivered via the Internet. The authors conclude that negative effects are to be expected and need to be acknowledged to a greater extent, advising researchers to systematically probe for negative effects whenever conducting clinical trials involving Internet interventions, as well as to share their findings in scientific journals.
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“A differential perspective may also highlight potential negative impacts of interventions or the absence of positive impacts in some participants (Rozental et al., 2014).”
From A Mindfulness-Based Intervention: Differential Effects on Affective and Processual Evolution (2018) · cites this paper as Rozental et al., 2014
In the citing paper
“Perspective is important because in contrast to face-to-face psychotherapy, aversive effects and non-response may be overlooked in distant program delivery (Rozental et al., 2014).”
From A Mindfulness-Based Intervention: Differential Effects on Affective and Processual Evolution (2018) · cites this paper as Rozental et al., 2014
In the citing paper
“Due to the latest recommendations, adverse events will be investigated twofold. First is using our questionnaire outcome measures—to determine the number of patients who deteriorated and those who did not respond to the treatment. Second is using a self-report measure to detect adverse events administered post-treatment (described above) [85].”
From Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder—study protocol for a randomized controlled trial (2023) · cites this paper as [85]
In the citing paper
“It has been shown that IMIs can have negative side effects [103–105], but those have been understudied so far [104].”
In the citing paper
“Additionally, negative treatment effects may occur in the context of internet interventions, and therefore, need to be acknowledged and systematically assessed.73”
From Development, evaluation and implementation of a digital behavioural health treatment for chronic pain: study protocol of the multiphase DAHLIA project (2022) · cites this paper as [73]
In the citing paper
“As recommended by Rozental et al. [51], we have included a question to identify any possible negative effects of the intervention. Deterioration between pre and post treatment will be reported, and the self-report question: ‘What, if any, positive or negative effects caused by the programme/being in the control group did you experience?’ will be asked.”
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Čepukienė, V., & Pakrosnis, R. (2018) · International Journal of Psychology a Biopsychosocial Approach · doi:10.7220/2345-024x.22.1 · Cited by 1
Learning how to recover from stress-related disorders via internet-based interventions
Asplund, R. P. (2021) · Linköping studies in behavioural science · doi:10.3384/diss.diva-172685 · Cited by 1
Bregenzer, A., & Jiménez, P. (2018) · Springer Reference Wirtschaft · doi:10.1007/978-3-658-17975-5_30-1 · Cited by 1
Bregenzer, A., & Jiménez, P. (2021) · Springer eBooks · doi:10.1007/978-3-658-17782-9_30 · Cited by 1
Schaeuffele, C., Heinrich, M., Behr, S., Fenski, F., Hammelrath, L., Zagorscak, P., Jansen, A., Pohl, S., Boettcher, J., & Knaevelsrud, C. (2022) · doi:10.31234/osf.io/ugwsx · Cited by 1
Self-citationYoshinaga, N., Thew, G. R., Hayashi, Y., Tanoue, H., Nakai, M., & Clark, D. M. (2024) · Trials · doi:10.1186/s13063-024-08303-6
“Mediation models will examine candidate mediators of the relationship between randomisation (treat-ment arm) and post-treatment LSAS scores following the procedure described by Freeman et al. [32].”
MethodInternet-based Treatment of Depression in Primary Care: Effectiveness and Feasibility
Kivi, M. (2015) · Gothenburg University Publications Electronic Archive (Gothenburg University)
Fobia społeczna – sposoby terapii z zastosowaniem internetu
Kozłowska, M. K. (2016) · Ogrody Nauk i Sztuk · doi:10.15503/onis2016.175.185
Boots, L. M. M. (2016) · doi:10.26481/dis.20160701lb · Cited by 5
Metadata
- Authors
- Rozental, A., Andersson, G., Boettcher, J., Ebert, D. D., Cuijpers, P., Knaevelsrud, C., Ljótsson, B., Kaldo, V., Titov, N., & Carlbring, P.
- Affiliations
- Stockholm University (SE)
- Linköping University (SE)
- Freie Universität Berlin (DE)
- Philipps University of Marburg (DE)
- Vrije Universiteit Amsterdam (NL)
- Karolinska Institutet (SE)
- Macquarie University (AU)
- Corresponding author
- Rozental, Alexander
- ORCID
- Venue
- Internet Interventions
- Publisher
- Elsevier BV
- Published
- 2014-03
- Volume
- 1
- Issue
- 1
- Pages
- 12-19
- ISSN
- 2214-7829 (ISSN-L)
- OpenAlex
- W2105822909
- Cited by
- 371
- References
- 82
- Citations by year
- 2026: 12 · 2025: 9 · 2024: 28 · 2023: 16 · 2022: 28 · 2021: 66 · 2020: 27 · 2019: 23 · 2018: 36 · 2017: 30 · 2016: 43 · 2015: 32 · 2014: 21
- FWCI
- 65.02
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Internet Interventions (publishedVersion, cc-by-nc-nd)
- VU Research Portal (publishedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UCL Discovery (University College London) (submittedVersion)
- Multilingual Matters (Channel View Publications) (submittedVersion, cc-by-nc-nd)
- Data Archiving and Networked Services (DANS) (submittedVersion, other-oa)
- Funders
- Swedish Research Council for Health, Working Life and Welfare (FORTE 2013-1107)
- Topics
- Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
- Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Telemedicine and Telehealth Implementation
- Keywords
- adverse outcomes, adverse events, treatment deterioration, psychotherapy research, clinical trials, adverse event reporting, psychotherapy
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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