iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

NCT05037344 | Completed

• 1 other identifier: AZ 53-5400.1-004/44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotherapy Intervention Evaluation

Keywords

cognitive-behavioral psychotherapy; obsessive-compulsive disorder; internet-based

Outcome Measures

Primary Outcomes (25)

• 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 Outcomes (3)

• Trauma History Questionaire (THQ)

  baseline

• Essener Trauma Inventory for Children and Adolescents (ETI-KJ)

  baseline

• Childhood trauma questionaire (CTQ)

  baseline

Study Arms (2)

Internet-based psychotherapy

EXPERIMENTAL

16 weeks of internet-based cognitive behavioral therapy

Behavioral: Cognitive-behavioral psychotherapy

Internet-based psychotherapy waiting group

ACTIVE COMPARATOR

16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks

Behavioral: Cognitive-behavioral psychotherapy

Interventions

Cognitive-behavioral psychotherapy BEHAVIORAL

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.

Internet-based psychotherapy; Internet-based psychotherapy waiting group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University Hospital Tuebingen

Tübingen, Germany

Location

Related Publications (2)

• 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.

  PMID: 36329915 DERIVED

• 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.

  PMID: 35189937 DERIVED

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Annette Conzelmann, Phd

  Department of Child and Adolescent Psychiatry University of Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Annette Conzelmann

Study Record Dates

• First Submitted: July 31, 2021
• First Posted: September 8, 2021
• Study Start: March 4, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Any time before and after completion of the study for 10 years.
• Access Criteria: Upon request.

Locations

DE (1)