iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Psychotherapy Intervention Evaluation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05037344
• Other study ID #: AZ 53-5400.1-004/44
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: July 2022
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder
• Psychotherapy Intervention Evaluation

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Essener Trauma Inventory for Children and Adolescents (ETI-KJ)	This questionnaire measures posttraumatic symptoms.	baseline
Other	Childhood trauma questionaire (CTQ)	This is a 24-item measure to traumatic events.	baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change in Impairment by OCD symptoms	Children and parents indicate impairment by OCD via app.	Every day throughout the therapy process
Primary	Change in Extend of avoidance behavior	Children and parents indicate extend of avoidance behavior via app.	Every day throughout the therapy process
Primary	Change in Daily mood	Children indicate their mood via app.	Every day throughout the therapy process
Primary	Change in How the day has been	Children indicate how good the day has been via app.	Every day throughout the therapy process
Primary	Change in How strong OCD is	Children and parants indicate how strong OCD is via app.	Every day throughout the therapy process
Primary	Change in How the week has been	Children and parants indicate how the week has been via app.	weekly throughout the therapy process
Primary	Change in Anxiety ratings during exposures	Children indicate how high anxiety was during exposures via app.	Every exposure throughout the therapy process
Primary	Change in Heart rate variability	Heart rate variability as an indicator of stress levels is assessed with wristbands.	Every day throughout the therapy process
Primary	Change in time the OCD takes	Children and parants indicate how much time OCD takes via app.	Every day throughout the therapy process
Primary	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
Primary	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
Primary	Change in How convinced the patient of his/her OCD thoughts is	assessed by App	every exposure
Primary	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