Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder: A mixed methods study and analysis plan for the TECTO trial

Linea Pretzmann*, Sofie Heidenheim Christensen, Anne Bryde Christensen, Camilla Funch Uhre, Valdemar Uhre, Christine Lykke Thoustrup, Iben Thiemer Clemmesen, Tin Aaen Gudmandsen, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Markus Harboe Olsen, Line Katrine Harder Clemmensen, Jane Lindschou, Christian Gluud, Per Hove Thomsen, Signe Vangkilde, Julie Hagstrøm, Alexander Rozental, Pia JeppesenFrank Verhulst, Katja Anna Hybel, Nicole Nadine Lønfeldt, Kerstin Jessica Plessen, Stig Poulsen, Anne Katrine Pagsberg

*Corresponding author af dette arbejde

Publikation: Bidrag til tidsskriftArtikelForskningpeer review

Abstract

BACKGROUND: Knowledge on adverse events in psychotherapy for youth with OCD is sparse. No official guidelines exist for defining or monitoring adverse events in psychotherapy. Recent recommendations call for more qualitative and quantitative assessment of adverse events in psychotherapy trials. This mixed methods study aims to expand knowledge on adverse events in psychotherapy for youth with OCD.

METHODS: This is an analysis plan for a convergent mixed methods study within a randomized clinical trial (the TECTO trial). We include at least 128 youth aged 8-17 years with obsessive-compulsive disorder (OCD). Participants are randomized to either family-based cognitive behavioral therapy (FCBT) or family-based psychoeducation and relaxation training (FPRT). Adverse events are monitored quantitatively with the Negative Effects Questionnaire. Furthermore, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured qualitative interviews with all youths and their parents on their experience of adverse events in FCBT or FPRT. For the mixed methods analysis, we will merge 1) a qualitative content analysis with descriptive statistics comparing the types, frequencies, and severity of adverse events; 2) a qualitative content analysis of the perceived causes for adverse events with prediction models for adverse events; and 3) a thematic analysis of the participants' treatment evaluation with a correlational analysis of adverse events and OCD severity.

DISCUSSION: The in-depth mixed methods analysis can inform 1) safer and more effective psychotherapy for OCD; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data.

TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

OriginalsprogEngelsk
Artikelnummer101173
TidsskriftContemporary Clinical Trials Communications
Vol/bind34
DOI
StatusUdgivet - aug. 2023

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