Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan
Background: Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an i...
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| Format: | Article |
| Language: | English |
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Elsevier
2025-02-01
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| Series: | Contemporary Clinical Trials Communications |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865424001558 |
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| author | Christine Lykke Thoustrup Camilla Uhre Valdemar Uhre Melanie Ritter Signe Vangkilde Janus Engstrøm Jane Lindschou Christian Gluud Anne Katrine Pagsberg Markus Harboe Olsen |
| author_facet | Christine Lykke Thoustrup Camilla Uhre Valdemar Uhre Melanie Ritter Signe Vangkilde Janus Engstrøm Jane Lindschou Christian Gluud Anne Katrine Pagsberg Markus Harboe Olsen |
| author_sort | Christine Lykke Thoustrup |
| collection | DOAJ |
| description | Background: Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD. Methods: Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses. Conclusion: This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias. |
| format | Article |
| id | doaj-art-235486414f7248dcacfcb4a17c64ab02 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-235486414f7248dcacfcb4a17c64ab022025-01-12T05:25:29ZengElsevierContemporary Clinical Trials Communications2451-86542025-02-0143101408Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis planChristine Lykke Thoustrup0Camilla Uhre1Valdemar Uhre2Melanie Ritter3Signe Vangkilde4Janus Engstrøm5Jane Lindschou6Christian Gluud7Anne Katrine Pagsberg8Markus Harboe Olsen9Child and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, Denmark; Corresponding author. Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark.Child and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Center for Clinical Neuropsychology, Children and Adolescents, Copenhagen University Hospital, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, DenmarkChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital - Amager and Hvidovre, Kettegård Allé 30, Afsnit 714, 2650, Hvidovre, DenmarkChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, DenmarkChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Department of Psychology, University of Copenhagen, Center for Sundhed og Samfund, Øster Farimagsgade 2A, 1353, Copenhagen, DenmarkCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Regional Health Research, The Faculty of Health Sciences, University of Southern Denmark, Odense, DenmarkChild and Adolescent Mental Health Center, Copenhagen University Hospital, Mental Health Services CPH, Gentofte Hospitalsvej 3A, 1. Sal, 2900, Hellerup, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Blegdamsvej 3B, 2200, Copenhagen, DenmarkCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark; Department of Neuroanaesthesiology, The Neuroscience Centre, Copenhagen University Hospital, Rigshospitalet, Copenhagen, DenmarkBackground: Research on improving psychotherapy for youths with obsessive-compulsive disorder (OCD), including cognitive behavioral therapy (CBT), should explore what works for whom and how by examining baseline moderators and potential mechanisms of change. Emotion dysregulation is proposed as an intermediate therapy factor in a transdiagnostic framework. This study investigates emotion dysregulation as an outcome, mechanism, and moderator of psychotherapy in youths aged 8–17 years with OCD. Methods: Data are from a randomized clinical trial and a parallel prospective study of healthy controls. Participants with OCD (n = 130; 121 in this study) were randomized to 14 sessions of either family-based CBT with exposure and response prevention versus family-based psychoeducation and relaxation training. We will; 1) assess if emotion dysregulation, measured by the Difficulties in Emotion Regulation Scale (DERS), decreases from baseline to end-of-treatment; 2) compare the proportion of participants with normative emotion regulation to a 90% reference interval from healthy controls (n = 90); 3) use linear regression to examine if baseline emotion dysregulation moderates treatment effects measured by the Children's Yale-Brown Obsessive-Compulsive Scale; 4) investigate if changes in emotion dysregulation mediate treatment effects; and 5) investigate the stability of emotion regulation over time in the healthy controls. Analyses 1–4 will be conducted for all OCD participants and separately for the two treatment groups. Two independent investigators will perform the analyses. Conclusion: This protocol and statistical analysis plan are presented to enhance analytical transparency and limit bias.http://www.sciencedirect.com/science/article/pii/S2451865424001558 |
| spellingShingle | Christine Lykke Thoustrup Camilla Uhre Valdemar Uhre Melanie Ritter Signe Vangkilde Janus Engstrøm Jane Lindschou Christian Gluud Anne Katrine Pagsberg Markus Harboe Olsen Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan Contemporary Clinical Trials Communications |
| title | Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan |
| title_full | Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan |
| title_fullStr | Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan |
| title_full_unstemmed | Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan |
| title_short | Emotion dysregulation in youths with obsessive-compulsive disorder and its implication for treatment - An exploratory study from the TECTO trial: A protocol and statistical analysis plan |
| title_sort | emotion dysregulation in youths with obsessive compulsive disorder and its implication for treatment an exploratory study from the tecto trial a protocol and statistical analysis plan |
| url | http://www.sciencedirect.com/science/article/pii/S2451865424001558 |
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