TY - JOUR

T1 - Family-based cognitive behavioural therapy versus family-based relaxation therapy for obsessive-compulsive disorder in children and adolescents

T2 - protocol for a randomised clinical trial (the TECTO trial)

AU - Pagsberg, Anne Katrine

AU - Uhre, Camilla

AU - Uhre, Valdemar

AU - Pretzmann, Linea

AU - Christensen, Sofie Heidenheim

AU - Thoustrup, Christine

AU - Clemmesen, Iben

AU - Gudmandsen, Amanda Aaen

AU - Korsbjerg, Nicoline Løcke Jepsen

AU - Mora-Jensen, Anna-Rosa Cecilie

AU - Ritter, Melanie

AU - Thorsen, Emilie D

AU - Halberg, Klara Sofie Vangstrup

AU - Bugge, Birgitte

AU - Staal, Nina

AU - Ingstrup, Helga Kristensen

AU - Moltke, Birgitte Borgbjerg

AU - Kloster, Anne Murphy

AU - Zoega, Pernille Juul

AU - Mikkelsen, Marie Sommer

AU - Harboe, Gitte Sommer

AU - Larsen, Katrin Frimann

AU - Clemmesen, Line Katrine Harder

AU - Lindschou, Jane

AU - Jakobsen, Janus Christian

AU - Engstrøm, Janus

AU - Gluud, Christian

AU - Siebner, Hartwig Roman

AU - Thomsen, Per Hove

AU - Hybel, Katja

AU - Verhulst, Frank

AU - Jeppesen, Pia

AU - Jepsen, Jens Richardt Møllegaard

AU - Vangkilde, Signe

AU - Olsen, Markus Harboe

AU - Hagstrøm, Julie

AU - Lønfeldt, Nicole Nadine

AU - Plessen, Kerstin Jessica

N1 - © 2022. The Author(s).

PY - 2022

Y1 - 2022

N2 - 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: ClinicalTrials.gov : NCT03595098, registered July 23, 2018.

AB - 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: ClinicalTrials.gov : NCT03595098, registered July 23, 2018.

KW - Adolescent

KW - Child

KW - Cognitive Behavioral Therapy/methods

KW - Family Therapy

KW - Humans

KW - Obsessive-Compulsive Disorder/psychology

KW - Outcome Assessment, Health Care

KW - Randomized Controlled Trials as Topic

KW - Relaxation Therapy

KW - Treatment Outcome

U2 - 10.1186/s12888-021-03669-2

DO - 10.1186/s12888-021-03669-2

M3 - Journal article

C2 - 35305587

VL - 22

JO - B M C Psychiatry

JF - B M C Psychiatry

SN - 1471-244X

IS - 1

M1 - 204

ER -