What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports

Christina Schulte; Theresa Sextl-Plötz; Harald Baumeister; Ingrid Titzler; Lasse B Sander; Cedric Sachser; Lena Steubl; Anna-Carlotta Zarski

doi:10.1016/j.invent.2024.100710

What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports

Internet Interv. 2024 Jan 24:35:100710. doi: 10.1016/j.invent.2024.100710. eCollection 2024 Mar.

Authors

Christina Schulte¹, Theresa Sextl-Plötz¹, Harald Baumeister², Ingrid Titzler³, Lasse B Sander⁴, Cedric Sachser⁵, Lena Steubl², Anna-Carlotta Zarski^{1

3

6}

Affiliations

¹ Technical University of Munich, Department of Sports and Health Sciences, Professorship Psychology and Digital Mental Health Care, Georg-Brauchle-Ring 60, 80992 Munich, Germany.
² Ulm University, Department of Clinical Psychology and Psychotherapy, Lise-Meitner-Str. 16, 89081 Ulm, Germany.
³ Friedrich-Alexander-Universität Erlangen-Nürnberg, Department of Clinical Psychology and Psychotherapy, Nägelsbachstr. 25a, 91052 Erlangen, Germany.
⁴ Medical Psychology and Medical Sociology, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
⁵ Ulm University, Department of Child and Adolescent Psychiatry and Psychotherapy, Steinhövelstraße 1, 89075 Ulm, Germany.
⁶ Philipps-University Marburg, Department of Clinical Psychology, Division of eHealth in Clinical Psychology, Schulstraße 12, 35032 Marburg, Germany.

Abstract

Background: Despite severely burdened individuals, often being excluded from research studies on internet- and mobile-based interventions (IMIs), negative events (NEs) including suicidal thoughts and behaviors (STBs) can still occur during a trial. NEs require monitoring and adequate safety measures. However, study protocols frequently lack comprehensive descriptions of procedures for managing NEs.

Aims: This study aimed to illustrate the assessment, monitoring, and procedures for addressing NEs in two studies on IMIs in adults and youth using case reports, to identify strengths and weaknesses of the NE management approaches, and to derive key learnings and recommendations.

Methods: Two case reports were drawn from two distinct IMI studies. The first study, PSYCHOnlineTHERAPY, evaluates the combination of an IMI with on-site psychotherapy for anxiety and depressive disorders in adults (adult blended study). The second study evaluates a standalone, therapist-guided IMI for post-traumatic stress disorder (PTSD) in youth (youth standalone study). Potential NEs were predefined depending on the study sample. The case studies thoroughly document the systematic recording and ongoing monitoring of NEs through self-report and observer-based assessments during the interventions. The cases illustrate a variety of NE management strategies, including automated and personalized approaches, adapted to the specific nature and severity of the NEs. The NE management approaches are visualized using decision trees.

Results: In the adult blended case study, online questionnaires detected STBs and triggered automated support information. As on-site therapy had already ended, a telephone consultation session allowed for the identification and discussion of the heightened intensity of suicidal thoughts, along with the development of specific additional help options. In the youth standalone case study, heightened tension in an adolescent with PTSD during trauma processing could be addressed in a telephone therapeutic session focusing on resource activation and emotion regulation. The referral to on-site treatment was supported. Overall, advantages of the NE management included automated procedures, multimodal assessment of a wide range of NEs, and standardized procedures tailored to different severity levels. Weaknesses included the use of single-item assessments for STBs and lack of procedures in case of deterioration or nonresponse to treatment.

Conclusion: This study provides practical insights and derives key learnings and recommendations regarding the management of NEs in different IMI contexts for both adults and youth.

Keywords: Case report; Internet intervention; Negative events; Suicidal thoughts and behaviors; eMental Health.