| 1. |
- Carlbring, Per, et al.
(författare)
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Consensus statement on defining and measuring negative effects of Internet interventions
- 2014
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Konferensbidrag (refereegranskat)abstract
- Background: Internet interventions have great potential for alleviating emotional distress, promoting mental health, and enhancing well-being. Numerous clinical trials have demonstrated their effectiveness 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.Objective: 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 study therefore sought out 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.Methods: Ten 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 dialogue 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.Results: 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.Conclusions: We 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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| 2. |
- de Graaff, Anne M., et al.
(författare)
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Scalable psychological interventions for Syrian refugees in Europe and the Middle East : STRENGTHS study protocol for a prospective individual participant data meta-analysis
- 2022
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Ingår i: BMJ Open. - : BMJ. - 2044-6055. ; 12:4
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Tidskriftsartikel (refereegranskat)abstract
- Introduction The World Health Organization's (WHO) scalable psychological interventions, such as Problem Management Plus (PM+) and Step-by-Step (SbS) are designed to be cost-effective non-specialist delivered interventions to reduce symptoms of common mental disorders, such as anxiety, depression and post-traumatic stress disorder (PTSD). The STRENGTHS consortium aims to evaluate the effectiveness, cost-effectiveness and implementation of the individual format of PM+ and its group version (gPM+), as well as of the digital SbS intervention among Syrian refugees in seven countries in Europe and the Middle East. This is a study protocol for a prospective individual participant data (IPD) meta-analysis to evaluate (1) overall effectiveness and cost-effectiveness and (2) treatment moderators of PM+, gPM+ and SbS with Syrian refugees. Methods and analysis Five pilot randomised controlled trials (RCTs) and seven fully powered RCTs conducted within STRENGTHS will be combined into one IPD meta-analytic dataset. The RCTs include Syrian refugees of 18 years and above with elevated psychological distress (Kessler Psychological Distress Scale (K10>15)) and impaired daily functioning (WHO Disability Assessment Schedule 2.0 (WHODAS 2.0>16)). Participants are randomised into the intervention or care as usual control group, and complete follow-up assessments at 1-week, 3-month and 12-month follow-up. Primary outcomes are symptoms of depression and anxiety (25-item Hopkins Symptom Checklist). Secondary outcomes include daily functioning (WHODAS 2.0), PTSD symptoms (PTSD Checklist for DSM-5) and self-identified problems (PSYCHLOPS). We will conduct a one-stage IPD meta-analysis using linear mixed models. Quality of evidence will be assessed using the GRADE approach, and the economic evaluation approach will be assessed using the CHEC-list. Ethics and dissemination Local ethical approval has been obtained for each RCT. This IPD meta-analysis does not require ethical approval. The results of this study will be published in international peer-reviewed journals.
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| 3. |
- Fenski, Friederike, et al.
(författare)
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Negative effects in internet-based interventions for depression : A qualitative content analysis
- 2021
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Ingår i: Internet Interventions. - : Elsevier. - 2214-7829. ; 26
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Tidskriftsartikel (refereegranskat)abstract
- An increasing number of studies is proving the efficacy of Internet-based interventions (IBI) for treating depression. While the focus of most studies is thereby lying on the potential of IBI to alleviate emotional distress and enhance well-being, few studies are investigating possible negative effects that might be encountered by participants. The current study was therefore exploring self-reported negative effects of participants undergoing a cognitive-behavioral IBI targeting mild to moderate depression over 6 weeks. Data from the client pool of a German insurance company (n = 814, 68% female) revealed that 8.6% of the participants reported the experience of negative effects. Qualitative content analysis yielded two broad categories and five subcategories for the nature of participants' experiences of negative effects: participant-related negative effects (insight and symptom) and program-related negative effects (online format, contact, and implementation). By using both, qualitative and quantitative methods, results did not only shed light on the characteristics of negative effects but analyses also found that working alliance was a predictor for the experience of negative effects. Monitoring the occurrences of negative effects as well as working alliance throughout treatment was considered essential to help prevent negative effects and attrition among participants undergoing IBI for depression.
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| 4. |
- Furukawa, Toshi A., et al.
(författare)
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Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression : a systematic review and component network meta-analysis using individual data
- 2021
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Ingår i: Lancet psychiatry. - London, United Kingdom : Elsevier. - 2215-0374 .- 2215-0366. ; 8:6, s. 500-511
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Forskningsöversikt (refereegranskat)abstract
- Findings We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42.0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1.83 [95% credible interval (CrI) -2.90 to -0.80]) and that relaxation might be harmful (1.20 [95% CrI 0.17 to 2.27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0.32 [95% CrI 0.13 to 0.93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components. 511
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| 5. |
- Karyotaki, Eirini, et al.
(författare)
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Internet-Based Cognitive Behavioral Therapy for Depression : A Systematic Review and Individual Patient Data Network Meta-analysis
- 2021
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Ingår i: JAMA psychiatry. - : American Medical Association. - 2168-6238 .- 2168-622X. ; 78:4, s. 361-371
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Forskningsöversikt (refereegranskat)abstract
- IMPORTANCE: Personalized treatment choices would increase the effectiveness of internet-based cognitive behavioral therapy (iCBT) for depression to the extent that patients differ in interventions that better suit them.OBJECTIVE: To provide personalized estimates of short-term and long-term relative efficacy of guided and unguided iCBT for depression using patient-level information.DATA SOURCES: We searched PubMed, Embase, PsycInfo, and Cochrane Library to identify randomized clinical trials (RCTs) published up to January 1, 2019.STUDY SELECTION: Eligible RCTs were those comparing guided or unguided iCBT against each other or against any control intervention in individuals with depression. Available individual patient data (IPD) was collected from all eligible studies. Depression symptom severity was assessed after treatment, 6 months, and 12 months after randomization.DATA EXTRACTION AND SYNTHESIS: We conducted a systematic review and IPD network meta-analysis and estimated relative treatment effect sizes across different patient characteristics through IPD network meta-regression.MAIN OUTCOMES AND MEASURES: Patient Health Questionnaire-9 (PHQ-9) scores.RESULTS: Of 42 eligible RCTs, 39 studies comprising 9751 participants with depression contributed IPD to the IPD network meta-analysis, of which 8107 IPD were synthesized. Overall, both guided and unguided iCBT were associated with more effectiveness as measured by PHQ-9 scores than control treatments over the short term and the long term. Guided iCBT was associated with more effectiveness than unguided iCBT (mean difference [MD] in posttreatment PHQ-9 scores, -0.8; 95% CI, -1.4 to -0.2), but we found no evidence of a difference at 6 or 12 months following randomization. Baseline depression was found to be the most important modifier of the relative association for efficacy of guided vs unguided iCBT. Differences between unguided and guided iCBT in people with baseline symptoms of subthreshold depression (PHQ-9 scores 5-9) were small, while guided iCBT was associated with overall better outcomes in patients with baseline PHQ-9 greater than 9.CONCLUSIONS AND RELEVANCE: In this network meta-analysis with IPD, guided iCBT was associated with more effectiveness than unguided iCBT for individuals with depression, benefits were more substantial in individuals with moderate to severe depression. Unguided iCBT was associated with similar effectiveness among individuals with symptoms of mild/subthreshold depression. Personalized treatment selection is entirely possible and necessary to ensure the best allocation of treatment resources for depression.
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| 7. |
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| 8. |
- Rozental, Alexander, et al.
(författare)
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Consensus statement on defining and measuring negative effects of Internet interventions
- 2014
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Ingår i: Internet Interventions. - : Elsevier BV. - 2214-7829. ; 1:1, s. 12-19
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Tidskriftsartikel (refereegranskat)abstract
- 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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| 9. |
- Rozental, Alexander, et al.
(författare)
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Consensus statement on defining and measuring negative effects of Internet interventions
- 2014
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Ingår i: Oral Abstracts from the 7th Scientific Meeting of the International Society for Research on Internet Interventions. ; , s. 39-39
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Purpose: Internet interventions provide a potential for promoting mental health and alleviating emotional distress. A large number of clinical trials have demonstrated their efficacy for several psychiatric conditions, and Internet interventions will likely become a common and valuable alternative within the regular health care. In the meantime, research has paid little attention to the possibility that some treatments might be associated with different types of negative effects. Evidence from face-to-face treatments suggests that 5-10% of all patients deteriorate despite receiving best available care. In addition, other forms of negative effects may exist as well, e.g., social stigmatization, interpersonal difficulties, and decreased self-esteem. However, a lack of agreement on how to define and measure negative effects has left researchers without practical guidelines for monitoring and reporting deterioration and adverse events in clinical trials, warranting a consensus for conducting research on negative effects.Method: The objective of the current paper is to provide recommendations that could promote the study of negative effects in Internet interventions. 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 dialogue and reach an agreement.Results: The importance of conducting further research on negative effects is discussed, and suggestions on how to classify and measure negative effects are provided, involving methods from quantitative and qualitative research. Potential mechanisms underlying negative effects are also presented, differentiating factors shared with face-to-face treatments from those unique to treatments delivered via the Internet.Conclusion: Negative effects should be expected and need to be recognized to a greater extent, and researchers are advised 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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| 10. |
- Sommer, Daniel, et al.
(författare)
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Challenger accepted?! Ergebnisse der Pilotierung einer App für Menschen mit sozialen Ängsten
- 2016
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Ingår i: 34. Symposium der Fachgruppe Klinische Psychologie und Psychotherapie der Deutschen Gesellschaft für Psychologie, Bielefeld 2016. ; , s. 201-202
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Hintergrund: Die Behandlung der sozialen Angststörung (SAS) durch internetbasierte kognitive Verhaltenstherapie (iKVT) verfügt bereits über breite Evidenz. Angesichts zunehmender Fokussierung auf internetfähige mobile Endgeräte für psychologische Interventionen überrascht es daher, dass bislang keine wissenschaftlich evaluierte Smartphone-Anwendung (App) für SAS in App-Stores erhältlich ist. Wir präsentieren Ergebnisse einer ersten randomisiert-kontrollierten Evaluierung der deutschen Version von „Challenger“ – einer speziell für Menschen mit sozialen Ängsten konzipierten, frei zugänglichen App. Ergänzend zu KVT- und Achtsamkeitselementen, generiert Challenger auf User zugeschnittene „Challenges“ - Expositionsübungen, Gedanken- und Verhaltensexperimente sowie Psychoedukation. Interaktive (peer-support) und innovative (Echtzeitanpassung an User-Umwelt mittels GPS) Elemente werden durch ein auf „Gamification“-Prinzipien beruhendes Konzept miteinander verknüpft. Methode: 77 sozial ängstliche Studierende wurden zwei Gruppen (6-wöchiger Zugang zur App oder Warteliste) randomisiert zugeteilt. Daten zu Nutzungsverhalten sowie Benutzerfreundlichkeit wurden erhoben. Soziale Ängstlichkeit wurde mit dem Social Phobia Inventory gemessen, sekundäre Maße umfassten allgemeine Ängstlichkeit, depressive und globale Symptombelastung. Ergebnisse: Die Auswertung der Nutzungsdaten ergab eine klare Präferenz für nicht-konfrontative Challenges, die ohne Beteiligung Dritter absolviert werden konnten. Zufriedenheits- und Benutzerfreundlichkeitsratings der App fielen gemischt aus. Analysen der Completer-Stichprobe zeigten eine signifikante Reduktion sozialer Ängste (Effektstärke PRÄ-POST innerhalb der Interventionsgruppe: d = - 0.94; zwischen Gruppen: d = 0.61), jedoch nicht-signifikante Verbesserungen auf sekundären Ergebnismaßen. Analysen nach Multipler Imputation fehlender Werte ergaben keine signifikanten Unterschiede. Diskussion: Zukünftige Herausforderungen in der Weiterentwicklung der App bestehen in einer Erhöhung der Nutzungsintensität wirksamer Elemente. Aufgrund des hohen Dropouts und Besonderheiten von Studiendesign und Stichprobe, erscheinen endgültige Schlüsse hinsichtlich der Wirksamkeit von Challenger verfrüht.
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