TY - JOUR

T1 - Adverse events in cognitive behavioral therapy and relaxation training for children and adolescents with obsessive-compulsive disorder

T2 - A mixed methods study and analysis plan for the TECTO trial

AU - Pretzmann, Linea

AU - Christensen, Sofie Heidenheim

AU - Bryde Christensen, Anne

AU - Funch Uhre, Camilla

AU - Uhre, Valdemar

AU - Thoustrup, Christine Lykke

AU - Clemmesen, Iben Thiemer

AU - Gudmandsen, Tin Aaen

AU - Korsbjerg, Nicoline Løcke Jepsen

AU - Mora-Jensen, Anna Rosa Cecilie

AU - Ritter, Melanie

AU - Olsen, Markus Harboe

AU - Clemmensen, Line Katrine Harder

AU - Lindschou, Jane

AU - Gluud, Christian

AU - Thomsen, Per Hove

AU - Vangkilde, Signe

AU - Hagstrøm, Julie

AU - Rozental, Alexander

AU - Jeppesen, Pia

AU - Verhulst, Frank

AU - Hybel, Katja Anna

AU - Lønfeldt, Nicole Nadine

AU - Plessen, Kerstin Jessica

AU - Poulsen, Stig

AU - Pagsberg, Anne Katrine

N1 - Publisher Copyright: © 2023 The Authors

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adverse effects

KW - Child

KW - Cognitive behavioral therapy

KW - Obsessive-compulsive disorder

KW - Randomized clinical trial

U2 - 10.1016/j.conctc.2023.101173

DO - 10.1016/j.conctc.2023.101173

M3 - Journal article

C2 - 37497354

AN - SCOPUS:85164460028

VL - 34

JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

M1 - 101173

ER -