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Rigshospitalet - a part of Copenhagen University Hospital

TECTO Trial: Treatment Effects of Family Based Cognitive Therapy in Children and Adolescents with Obsessive Compulsive Disorder

Project: Types of projectsProject

  • Pagsberg, Anne Katrine (Project Manager, organisational)
  • Siebner, Hartwig R. (Project Manager, academic)
  • Verhulst, Frank (Project participant)
  • Vangkilde, Signe Allerup (Project participant)
  • Thomsen, Per Hove (Project participant)
  • Gluud, Christian (Project participant)
  • Jakobsen, Janus Christian (Project participant)
  • Lindschou, Jane (Project participant)
  • Staal, Nina (Project participant)
  • Plessen , Kerstin J (Project participant)
  • Lønfeldt, Nicole Nadine (Project participant)
  • Baladi Nejad, Ayna (Project participant)
  • Baaré, William Frans Christian (Project participant)
  • Andersen, Kasper Winther (Project participant)
  • Uhre, Camilla Funch (Project participant)
  • Pretzmann, Linea (Project participant)
  • Hagstrøm, Julie (Project participant)
  • Clemmesen, Iben (Project participant)
  • Aaen Gudmandsen, Amanda (Project participant)
  • Sommer Harboe, Gitte (Project participant)
  • Hybel, Katja, Aarhus University Hospital, Denmark (Project participant)
  • Jørgensen, Niklas Rye (Project participant)
  • Clemmensen, Line, Denmark Technical University, DTU Compute, Denmark (Project participant)
  • Bugge, Birgitte (Project participant)
  • Christensen, Sofie Heidenheim (Project participant)
  • Uhre, Valdemar Funch (Project participant)
  • Thoustrup, Christine (Project participant)
  • Korsbjerg, Nicoline (Project participant)
  • Mora-Jensen, Cecilie (Project participant)
  • Damløv Thorsen, Emilie (Project participant)
  • Ritter, Melanie (Project participant)
  • Espensen, Frederik Ganci (Project participant)
  • Hougaard, Anton Harald (Project participant)
  • Ingstrup, Helga (Project participant)
  • Halberg, Klara Sofie Vangstrup (Project participant)
  • Larsen, Katrin Frimann (Project participant)
  • Lydolff, Anne (Project participant)
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Cognitive behavioural therapy is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder. Evidence concerning beneficial and harmful effects compared with other interventions, and the underlying neurobiological, neurocognitive, and emotional mechanisms of action, have not yet been determined. Combining randomised clinical trials with neuroimaging methodology allows the determination of specific mediators of cognitive behavioural therapy. Such a design controls for potential non-specific therapeutic effects gained from factors such as attention to symptoms, and regular visits with a therapist. Objectives: To investigate the benefits and harms, and the neural, neurocognitive, neuroendocrine, and emotional mediators of treatment response, in family-based cognitive behavioural therapy versus family-based psychoeducation and relaxation training in children and adolescents with obsessive compulsive disorder. We aim to conduct this investigation in an optimal trial design with the lowest possible risk of bias.

This trial is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial with blinded outcome assessment. The trial is combined with a case-control study, applying magnetic resonance imaging scans of the brain, immunoassays of salivary oxytocin, and neuropsychological and psychophysiological testing to participants with obsessive-compulsive disorder pre-, during, and post-treatment.

Results (expected):
Results from this trial, positive, negative as well as inconclusive, will be published in peer-reviewed scientific journals and presented at national and international congresses and workshops as soon as the data are analysed.

Discussion/Impact (expected):
Our systematic review of CBT trials in paediatric OCD showed that the overall ROB in previous randomised trials was significantly high. Even though certain elements of bias cannot be avoided due to the nature of psychotherapeutic intervention, others can be addressed and reduced (attrition bias, balancing interventions and avoiding competing interests). Futhermore, the question of how CBT treatment effects the central nervous system and mediates the response is not known. Therefore, it is ethically justifiable to investigate CBT as the experimental intervention in this trial. It is imperative to include children and adolscents in OCD trials because models of OCD etiology and of treatment mechanisms in CBT for OCD proposed in adults cannot necessarily be extended to children and adolescents. Although OCD symptomatology is similar in children, adolescents and adults, there are important differences in developmental psychopathology. Children with OCD may not perceive their symptoms as excessive and unrealistic, which may affect motivation for treatment. Furthermore, children are more likely to suffer from comorbid disorders, have poorer frustration tolerance and coping abilities, and parents are more likely to be involved in the childs’ symptoms. OCD symptoms of children can affect the functional level of the family, and parents and close family members should therefore be involved in the treatment. To address these issues, it is necessary for research in psychotherapy to target younger age groups. The need for developmentally adapted treatment is reflected in the guidelines for treatment of OCD, in which they distinguish between recommendations of treatment for children and adolescents and treatment for adults. The differences between children and adults with OCD can also be seen neurologically, which gives rise to believe that a possible neural effect of psychotherapy may differ between children and adults. It is therefore important to investigate neurobiological, neurocognitive, and emotional mediators of psychotherapy for children. As OCD often develops in childhood and can become chronic if left untreated, early intervention is crucial.

ID: 61797921