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)

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 MikkelsenGitte Sommer Harboe, Katrin Frimann Larsen, Line Katrine Harder Clemmesen, 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

*Corresponding author for this work

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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 < 70; or treatment with CBT, PRT, antidepressant or antipsychotic medication within the last 6 months prior to trial entry. Participants are randomised 1:1 to the experimental intervention (FCBT) versus the control intervention (FPRT) each consisting of 14 75-min sessions. All therapists deliver both interventions. Follow-up assessments occur in week 4, 8 and 16 (end-of-treatment). The primary outcome is OCD symptom severity assessed with CY-BOCS at end-of-trial. Secondary outcomes are quality-of-life and adverse events. Based on sample size estimation, a minimum of 128 participants (64 in each intervention group) are included. 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: NCT03595098, registered July 23, 2018.

Original languageEnglish
Article number204
JournalBMC Psychiatry
Number of pages15
Publication statusPublished - 19. Mar 2022

Bibliographical note

Publisher Copyright:
© 2022, The Author(s).


  • Adolescents
  • Children
  • Cognitive behavioural therapy
  • Obsessive-compulsive disorder
  • Psycho-education and relaxation training
  • Randomised clinical trial
  • Treatment effects
  • Youth
  • Humans
  • Treatment Outcome
  • Randomized Controlled Trials as Topic
  • Relaxation Therapy
  • Family Therapy
  • Adolescent
  • Obsessive-Compulsive Disorder/psychology
  • Cognitive Behavioral Therapy/methods
  • Outcome Assessment, Health Care
  • Child


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