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

20 Pages Posted: 7 Feb 2023

See all articles by Linea Pretzmann

Linea Pretzmann

Copenhagen University - Child and Adolescent Mental Health Centre

Sofie Heidenheim Christensen

Copenhagen University - Child and Adolescent Mental Health Centre

Anne Bryde Christensen

University of Copenhagen - Mental Health Centre Ballerup

Camilla Uhre

Copenhagen University - Child and Adolescent Mental Health Centre

Valdemar Uhre

Copenhagen University - Child and Adolescent Mental Health Centre

Christine Lykke Thoustrup

Copenhagen University - Child and Adolescent Mental Health Centre

Iben Thiemer Clemmesen

Copenhagen University - Child and Adolescent Mental Health Centre

Tin Aaen Gudmandsen

Copenhagen University - Child and Adolescent Mental Health Centre

Nicoline Løcke Jepsen Korsbjerg

Copenhagen University - Child and Adolescent Mental Health Centre

Anna-Rosa Cecilie Mora-Jensen

Copenhagen University - Child and Adolescent Mental Health Centre

Melanie Ritter

Copenhagen University - Child and Adolescent Mental Health Centre

Markus Harboe Olsen

University of Copenhagen - Copenhagen University Hospital

Line Katrine Harder Clemmensen

Technical University of Denmark

Jane Lindschou

University of Copenhagen - Copenhagen University Hospital

Christian Gluud

Copenhagen University Hospital - Copenhagen Trial Unit

Per Hove Thomsen

Aarhus University - Aarhus University Hospital

Signe Vangkilde

Copenhagen University - Child and Adolescent Mental Health Centre

Julie Hagstrøm

Copenhagen University - Child and Adolescent Mental Health Centre

Alexander Rozental

Karolinska Institutet - Centre for Psychiatry Research

Pia Jeppesen

Copenhagen University - Child and Adolescent Mental Health Centre

Frank Verhulst

Copenhagen University - Child and Adolescent Mental Health Centre

Katja Anna Hybel

Aarhus University - Aarhus University Hospital

Nicole Nadine Lønfeldt

Copenhagen University - Child and Adolescent Mental Health Centre

Kerstin J. Plessen

Copenhagen University - Child and Adolescent Mental Health Centre

Stig Poulsen

University of Copenhagen

Anne Katrine Pagsberg

University of Copenhagen

Abstract

Background: No official guidelines or validated instruments exist for defining or monitoring adverse events in psychotherapy for children and adolescents. This study aims to investigate if and how adverse events relate to family-based cognitive behavioral therapy (FCBT) versus family-based psychoeducation and relaxation therapy (FPRT) for youth (<18 years) with obsessive-compulsive disorder (OCD). We outline a mixed methods analysis plan of adverse events in a randomized clinical trial.

Methods: This is a convergent mixed methods study within the TECTO trial. We include at least 128 youth aged 8 to 17 years with OCD. Participants are randomized to either FCBT or FPRT and adverse events are monitored quantitatively with the Negative Effects Questionnaire. Further, we assess psychiatric symptoms, global functioning, quality of life, and family factors to investigate predictors for adverse events. We conduct semi-structured interviews with all youths and their parents on their experience of 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 CBT; 2) instruments and guidelines for monitoring adverse events; and 3) patient information on potential adverse events. The main limitation is risk of missing data.

Note:

Funding Declaration: This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. This TECTO sub-study is financed by the Research Unit at the Child and Adolescent Mental Health Centre in the Capital Region of Denmark. Funding for the entire TECTO trial is published in the study protocol [33].

Conflict of Interest: No authors have declared competing financial or non-financial interests.

Ethical Information: Data collection for the mixed methods study received approval from The Ethics Committee of the Capital Region of Denmark (H-18010607) and The Knowledge Centre on Data Protection Compliance in The Capital Region of Denmark (VD-2018-263, I-Suite no.: 6502) as part of the TECTO trial protocol [33]. Participants consent to participate in this sub-study when entering the TECTO trial and can withdraw consent to participate at any time.

Trial Registration: ClinicalTrials.gov identifier: NCT03595098. Registered on July 23, 2018.

Keywords: adverse effects, obsessive-compulsive disorder, cognitive behavioral therapy, Child, Adolescent

Suggested Citation

Pretzmann, Linea and Christensen, Sofie Heidenheim and Christensen, Anne Bryde and Uhre, Camilla and Uhre, Valdemar and Thoustrup, Christine Lykke and Clemmesen, Iben Thiemer and Gudmandsen, Tin Aaen and Korsbjerg, Nicoline Løcke Jepsen and Mora-Jensen, Anna-Rosa Cecilie and Ritter, Melanie and Olsen, Markus Harboe and Clemmensen, Line Katrine Harder and Lindschou, Jane and Gluud, Christian and Thomsen, Per Hove and Vangkilde, Signe and Hagstrøm, Julie and Rozental, Alexander and Jeppesen, Pia and Verhulst, Frank and Hybel, Katja Anna and Lønfeldt, Nicole Nadine and Plessen, Kerstin J. and Poulsen, Stig and Pagsberg, Anne Katrine, 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. Available at SSRN: https://ssrn.com/abstract=4333986 or http://dx.doi.org/10.2139/ssrn.4333986

Linea Pretzmann (Contact Author)

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Sofie Heidenheim Christensen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Anne Bryde Christensen

University of Copenhagen - Mental Health Centre Ballerup ( email )

Camilla Uhre

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Valdemar Uhre

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Christine Lykke Thoustrup

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Iben Thiemer Clemmesen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Tin Aaen Gudmandsen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Nicoline Løcke Jepsen Korsbjerg

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Anna-Rosa Cecilie Mora-Jensen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Melanie Ritter

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Markus Harboe Olsen

University of Copenhagen - Copenhagen University Hospital ( email )

Line Katrine Harder Clemmensen

Technical University of Denmark ( email )

Jane Lindschou

University of Copenhagen - Copenhagen University Hospital ( email )

Christian Gluud

Copenhagen University Hospital - Copenhagen Trial Unit ( email )

Copenhagen, 2100
Denmark

Per Hove Thomsen

Aarhus University - Aarhus University Hospital ( email )

Signe Vangkilde

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Julie Hagstrøm

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Alexander Rozental

Karolinska Institutet - Centre for Psychiatry Research ( email )

Pia Jeppesen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Frank Verhulst

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Katja Anna Hybel

Aarhus University - Aarhus University Hospital ( email )

Nicole Nadine Lønfeldt

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Kerstin J. Plessen

Copenhagen University - Child and Adolescent Mental Health Centre ( email )

Stig Poulsen

University of Copenhagen ( email )

Anne Katrine Pagsberg

University of Copenhagen ( email )

Nørregade 10
Copenhagen, DK-1165
Denmark

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