Clinical trial NCT05037344: iCBT for Children and Adolescents With Obsessive-compulsive Disorder II
Official title: Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotherapy Intervention Evaluation
Keywords: cognitive-behavioral psychotherapy
obsessive-compulsive disorder
internet-based
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.

Detailed description: In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).

Eligibility criteria: Inclusion Criteria:

* Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
* German-speaking (child \& caretakers)
* Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone
* written informed content of the child and his caretaker
* OCD as highest treatment priority

Exclusion Criteria:

* IQ below 70
* not speaking and understanding German
* A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Primary outcomes:
measure: Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Child Behavior Checklist (CBCL/6-18R)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Youth Self-Report (YSR/11-18R)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Depression Inventory for Children and Adolescents (DIKJ)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Junior temperament and character inventory (JTCI)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Clinical Global Impressions-Severity (CGI-S)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Clinical Global Impressions-Improvement (CGI-I)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Impairment by OCD symptoms
timeFrame: Every day throughout the therapy process
measure: Change in Extend of avoidance behavior
timeFrame: Every day throughout the therapy process
measure: Change in Daily mood
timeFrame: Every day throughout the therapy process
measure: Change in How the day has been
timeFrame: Every day throughout the therapy process
measure: Change in How strong OCD is
timeFrame: Every day throughout the therapy process
measure: Change in How the week has been
timeFrame: weekly throughout the therapy process
measure: Change in Anxiety ratings during exposures
timeFrame: Every exposure throughout the therapy process
measure: Change in Heart rate variability
timeFrame: Every day throughout the therapy process
measure: Change in time the OCD takes
timeFrame: Every day throughout the therapy process
measure: Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in Engagement- Fragebogen
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
measure: Change in How convinced the patient of his/her OCD thoughts is
timeFrame: every exposure
measure: Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
timeFrame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Secondary outcomes:
Other outcomes:
measure: Trauma History Questionaire (THQ)
timeFrame: baseline
measure: Essener Trauma Inventory for Children and Adolescents (ETI-KJ)
timeFrame: baseline
measure: Childhood trauma questionaire (CTQ)
timeFrame: baseline
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: Department of Child and Adolescent Psychiatry University of Tübingen
name: Annette Conzelmann, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hollmann K, Hohnecker CS, Haigis A, Alt AK, Kuhnhausen J, Pascher A, Worz U, App R, Lautenbacher H, Renner TJ, Conzelmann A. Internet-based cognitive behavioral therapy in children and adolescents with obsessive-compulsive disorder: A randomized controlled trial. Front Psychiatry. 2022 Oct 18;13:989550. doi: 10.3389/fpsyt.2022.989550. eCollection 2022.
citation: Conzelmann A, Hollmann K, Haigis A, Lautenbacher H, Bizu V, App R, Nickola M, Wewetzer G, Wewetzer C, Ivarsson T, Skokauskas N, Wolters LH, Skarphedinsson G, Weidle B, de Haan E, Torp NC, Compton SN, Calvo R, Lera-Miguel S, Alt A, Hohnecker CS, Allgaier K, Renner TJ. Internet-based psychotherapy in children with obsessive-compulsive disorder (OCD): protocol of a randomized controlled trial. Trials. 2022 Feb 21;23(1):164. doi: 10.1186/s13063-022-06062-w.