iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II

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.

Study Overview

• Status: Completed
• Conditions: Psychotherapy Intervention Evaluation
• Intervention / Treatment: Behavioral: Cognitive-behavioral psychotherapy

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Tuebingen, Germany
    • University Hospital Tuebingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Internet-based psychotherapy; 16 weeks of internet-based cognitive behavioral therapy	Behavioral: Cognitive-behavioral psychotherapy; The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.
ACTIVE_COMPARATOR: Internet-based psychotherapy waiting group; 16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks	Behavioral: Cognitive-behavioral psychotherapy; The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)	Clinical interview for psychiatric disorders for children and parents.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	Interview/questionnaire for obsessive-compusive disorders.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Global Assessment Scale (CGAS)	The CGAS is a measure of level of functioning in children and adolescents.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Behavior Checklist (CBCL/6-18R)	A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)	A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)	A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Youth Self-Report (YSR/11-18R)	A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Depression Inventory for Children and Adolescents (DIKJ)	The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Junior temperament and character inventory (JTCI)	The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)	The SCARED assesses DSM-IV anxiety symptoms.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Severity (CGI-S)	A clinical 7-point rating scale of symptom severity.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Improvement (CGI-I)	A clinical 7-point rating scale of symptom severity.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Impairment by OCD symptoms	Children and parents indicate impairment by OCD via app.	Every day throughout the therapy process
Change in Extend of avoidance behavior	Children and parents indicate extend of avoidance behavior via app.	Every day throughout the therapy process
Change in Daily mood	Children indicate their mood via app.	Every day throughout the therapy process
Change in How the day has been	Children indicate how good the day has been via app.	Every day throughout the therapy process
Change in How strong OCD is	Children and parants indicate how strong OCD is via app.	Every day throughout the therapy process
Change in How the week has been	Children and parants indicate how the week has been via app.	weekly throughout the therapy process
Change in Anxiety ratings during exposures	Children indicate how high anxiety was during exposures via app.	Every exposure throughout the therapy process
Change in Heart rate variability	Heart rate variability as an indicator of stress levels is assessed with wristbands.	Every day throughout the therapy process
Change in time the OCD takes	Children and parants indicate how much time OCD takes via app.	Every day throughout the therapy process
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)	This questionnaire assesses the core personality traits of children.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Engagement- Fragebogen	Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in How convinced the patient of his/her OCD thoughts is	assessed by App	every exposure
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)	Questionnaire to life quality of parents related to the impairment through the illness of the child.	baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma History Questionaire (THQ)	This is a 5-point scale and 28 items that measures trauma experience such as sexual abuse or emotional neglect.	baseline
Essener Trauma Inventory for Children and Adolescents (ETI-KJ)	This questionnaire measures posttraumatic symptoms.	baseline
Childhood trauma questionaire (CTQ)	This is a 24-item measure to traumatic events.	baseline

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2019
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ACTUAL): April 30, 2022

Study Registration Dates

• First Submitted: July 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (ACTUAL): September 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: obsessive-compulsive disorder; internet-based; cognitive-behavioral psychotherapy
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: AZ 53-5400.1-004/44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We share study matterial and statistical outputs.
• IPD Sharing Time Frame: Any time before and after completion of the study for 10 years.
• IPD Sharing Access Criteria: Upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No