iCBT for Children and Adolescents With Obsessive-compulsive Disorder

Not Applicable

• Conditions: Psychotherapy Intervention Evaluation
• Interventions: Behavioral: Cognitive-bahavioral psychotherapy

• Registration Number: NCT02973932
• Lead Sponsor: University Hospital Tuebingen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-25
• Last Update Submitted: 2016-11-25
• Study First Posted: 2016-11-28
• Last Update Posted: 2016-11-28
• Primary Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Internet-based psychotherapy	Cognitive-bahavioral psychotherapy	-

Primary Outcome Measures

Name	Time	Method
How the day was	Every day throughout the therapy process (14 weeks)	assessed by App
Heart rate variability	Every day throughout the therapy (14 weeks)	assessed with wristband
Body movements	Every day throughout the therapy (14 weeks)	assessed with wristband
Impairment by OCD symptoms	Every day throughout the therapy process (14 weeks)	assessed by App
Body temperature	Every day throughout the therapy (14 weeks)	assessed with wristband
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)
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	beginning of the study and end therapy (about 16 weeks)
Extend of avoidance behavior	Every day throughout the therapy process (14 weeks)	assessed by App
How Every week throughout the therapy processgood e progress was with specific treatment goals	Every week throughout the therapy process (14 weeks)	assessed by App
Anxiety ratings during exposures	Every week three days beginning with session 4 up to 14	assessed by App
Children's Global Assessment Scale (CGAS)	beginning of the study and end therapy (about 16 weeks)
Child Behavior Checklist (CBCL)	beginning of the study and end therapy (about 16 weeks)
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)	beginning of the study and end therapy (about 16 weeks)
Daily mood	Every day throughout the therapy process (14 weeks)	assessed by App
How strong OCD is	Every week throughout the therapy process (14 weeks)	assessed by App
Skin conductance level	Every day throughout the therapy (14 weeks)	assessed with wristband