iCBT for Children and Adolescents With Obsessive-compulsive Disorder

Psychotherapy Intervention Evaluation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02973932
• Other study ID #: F.1331477
• Status: Not yet recruiting
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 25, 2016
• Start date: November 2016

Study information

• Verified date: November 2016
• Source: University Hospital Tuebingen
• Contact: Annette Conzelmann, PhD
• Phone: 004970712987513
• Email: annette.conzelmann[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 7 to 17 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 17 Years

Eligibility

Inclusion Criteria:

• Children and adolescents (ages 7-17) 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

Exclusion Criteria:

• IQ below 70

• A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality that requires acute treatment, and psychosis

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder
• Psychotherapy Intervention Evaluation

Intervention

Behavioral:
• Cognitive-bahavioral psychotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)		beginning of the study and end therapy (about 16 weeks)	No
Primary	The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)		beginning of the study and end therapy (about 16 weeks)	No
Primary	Children's Global Assessment Scale (CGAS)		beginning of the study and end therapy (about 16 weeks)	No
Primary	Child Behavior Checklist (CBCL)		beginning of the study and end therapy (about 16 weeks)	No
Primary	Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)		beginning of the study and end therapy (about 16 weeks)	No
Primary	Impairment by OCD symptoms	assessed by App	Every day throughout the therapy process (14 weeks)	No
Primary	Extend of avoidance behavior	assessed by App	Every day throughout the therapy process (14 weeks)	No
Primary	Daily mood	assessed by App	Every day throughout the therapy process (14 weeks)	No
Primary	How the day was	assessed by App	Every day throughout the therapy process (14 weeks)	No
Primary	How strong OCD is	assessed by App	Every week throughout the therapy process (14 weeks)	No
Primary	How Every week throughout the therapy processgood e progress was with specific treatment goals	assessed by App	Every week throughout the therapy process (14 weeks)	No
Primary	Anxiety ratings during exposures	assessed by App	Every week three days beginning with session 4 up to 14	No
Primary	Heart rate variability	assessed with wristband	Every day throughout the therapy (14 weeks)	No
Primary	Skin conductance level	assessed with wristband	Every day throughout the therapy (14 weeks)	No
Primary	Body temperature	assessed with wristband	Every day throughout the therapy (14 weeks)	No
Primary	Body movements	assessed with wristband	Every day throughout the therapy (14 weeks)	No