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 highlight potential negative impacts or absence of positive impacts in some participants.
“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 contrast to face-to-face psychotherapy, aversive effects and non-response may be overlooked in distant program delivery.
“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
Adverse events will be investigated using questionnaire outcome measures to determine deterioration and non-response, and using a self-report measure to detect adverse events post-treatment.
“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]
It has been shown that IMIs can have negative side effects.
“It has been shown that IMIs can have negative side effects [103–105], but those have been understudied so far [104].”
Negative treatment effects may occur in the context of internet interventions and need to be acknowledged and systematically assessed.
“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]
As recommended by Rozental et al., a question to identify possible negative effects of the intervention was included, and deterioration between pre and post treatment will be reported.
“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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“Negative effects related to treatment were also measured, in two of the ways suggested by Rozental et al. (2014): by measuring deterioration and by asking a simple open-ended question about adverse events post-treatment.”
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“[46].”
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Self-citationInternet-Delivered Cognitive-Behavior Therapy for Tinnitus: A Randomized Controlled Trial
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Self-citationExperiences of non-adherence to Internet-delivered cognitive behavior therapy: a qualitative study
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Self-citationWorking on self-compassion online: a proof of concept and feasibility study
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Self-citationClinicians' Perspectives on Negative Effects of Psychological Treatments
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Self-citationWeb-based individual Mindfulness-Based Cognitive Therapy for cancer-related fatigue — A pilot study
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Internet-Based Interventions in Chronic Somatic Disease
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Internet-Delivered Cognitive Behavior Therapy for Anxiety Disorders Is Here to Stay
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Self-citation
- 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
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