Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents:protocol for a randomised clinical trial (the TECTO trial)
| Autor: | Anne Katrine Pagsberg, Camilla Uhre, Valdemar Uhre, Linea Pretzmann, Sofie Heidenheim Christensen, Christine Thoustrup, Iben Clemmesen, Amanda Aaen Gudmandsen, Nicoline Løcke Jepsen Korsbjerg, Anna-Rosa Cecilie Mora-Jensen, Melanie Ritter, Emilie D. Thorsen, Klara Sofie Vangstrup Halberg, Birgitte Bugge, Nina Staal, Helga Kristensen Ingstrup, Birgitte Borgbjerg Moltke, Anne Murphy Kloster, Pernille Juul Zoega, Marie Sommer Mikkelsen, Gitte Sommer Harboe, Katrin Frimann Larsen, Line Katrine Harder Clemmensen, Jane Lindschou, Janus Christian Jakobsen, Janus Engstrøm, Christian Gluud, Hartwig Roman Siebner, Per Hove Thomsen, Katja Hybel, Frank Verhulst, Pia Jeppesen, Jens Richardt Møllegaard Jepsen, Signe Vangkilde, Markus Harboe Olsen, Julie Hagstrøm, Nicole Nadine Lønfeldt, Kerstin Jessica Plessen |
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| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Obsessive-Compulsive Disorder
Youth Cognitive Behavioral Therapy Adolescent Obsessive-Compulsive Disorder/psychology Cognitive Behavioral Therapy/methods Cognitive behavioural therapy Relaxation Therapy Adolescents behavioral disciplines and activities Randomised clinical trial Treatment effects Psychiatry and Mental health Treatment Outcome SDG 3 - Good Health and Well-being Psycho-education and relaxation training mental disorders Outcome Assessment Health Care Obsessive-compulsive disorder Humans Family Therapy Child Children Randomized Controlled Trials as Topic |
| Zdroj: | Pagsberg, A K, Uhre, C, Uhre, V, Pretzmann, L, Christensen, S H, Thoustrup, C, Clemmesen, I, Gudmandsen, A A, Korsbjerg, N L J, Mora-Jensen, A-R C, Ritter, M, Thorsen, E D, Halberg, K S V, Bugge, B, Staal, N, Ingstrup, H K, Moltke, B B, Kloster, A M, Zoega, P J, Mikkelsen, M S, Harboe, G S, Larsen, K F, Clemmesen, L K H, Lindschou, J, Jakobsen, J C, Engstrøm, J, Gluud, C, Siebner, H R, Thomsen, P H, Hybel, K, Verhulst, F, Jeppesen, P, Jepsen, J R M, Vangkilde, S, Olsen, M H, Hagstrøm, J, Lønfeldt, N N & Plessen, K J 2022, ' Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents : protocol for a randomised clinical trial (the TECTO trial) ', BMC Psychiatry, vol. 22, no. 1, 204 . https://doi.org/10.1186/s12888-021-03669-2 Pagsberg, A K, Uhre, C, Uhre, V, Pretzmann, L, Christensen, S H, Thoustrup, C, Clemmesen, I, Gudmandsen, A A, Korsbjerg, N L J, Mora-Jensen, A R C, Ritter, M, Thorsen, E D, Halberg, K S V, Bugge, B, Staal, N, Ingstrup, H K, Moltke, B B, Kloster, A M, Zoega, P J, Mikkelsen, M S, Harboe, G S, Larsen, K F, Clemmesen, L K H, Lindschou, J, Jakobsen, J C, Engstrøm, J, Gluud, C, Siebner, H R, Thomsen, P H, Hybel, K, Verhulst, F, Jeppesen, P, Jepsen, J R M, Vangkilde, S, Olsen, M H, Hagstrøm, J, Lønfeldt, N N & Plessen, K J 2022, ' Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents : protocol for a randomised clinical trial (the TECTO trial) ', BMC Psychiatry, vol. 22, 204 . https://doi.org/10.1186/s12888-021-03669-2 Pagsberg, A K, Uhre, C, Uhre, V, Pretzmann, L, Christensen, S H, Thoustrup, C, Clemmesen, I, Gudmandsen, A A, Korsbjerg, N L J, Mora-Jensen, A-R C, Ritter, M, Thorsen, E D, Halberg, K S V, Bugge, B, Staal, N, Ingstrup, H K, Moltke, B B, Kloster, A M, Zoega, P J, Mikkelsen, M S, Harboe, G S, Larsen, K F, Clemmensen, L K H, Lindschou, J, Jakobsen, J C, Engstrom, J, Gluud, C, Siebner, H R, Thomsen, P H, Hybel, K, Verhulst, F, Jeppesen, P, Jepsen, J R M, Vangkilde, S, Olsen, M H, Hagstrom, J, Lonfeldt, N N & Plessen, K J 2022, ' Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents: protocol for a randomised clinical trial (the TECTO trial) ', BMC Psychiatry, vol. 22, no. 1, 204 . https://doi.org/10.1186/s12888-021-03669-2 |
| Popis: | Background Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias. Methods This is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial (RCT). Outcome assessors, data managers, statisticians, and conclusion drawers are blinded. From child and adolescent mental health services we include patients aged 8–17 years with a primary OCD diagnosis and an entry score of ≥16 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We exclude patients with comorbid illness contraindicating trial participation; intelligence quotient Discussion In our trial design we aim to reduce risk-of-bias, enhance generalisability, and broaden the outcome measures by: 1) conducting an investigator-initiated, independently funded RCT; 2) blinding investigators; 3) investigating a representative sample of OCD patients; 3) using an active control intervention (FPRT) to tease apart general and specific therapy effects; 4) using equal dosing of interventions and therapist supervision in both intervention groups; 5) having therapists perform both interventions decided by randomisation; 6) rating fidelity of both interventions; 7) assessing a broad range of benefits and harms with repeated measures. The primary study limitations are the risk of missing data and the inability to blind participants and therapists to the intervention. Trial registration ClinicalTrials.gov: NCT03595098, registered July 23, 2018. |
| Databáze: | OpenAIRE |
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