iCBT for Children and Adolescents With Obsessive-compulsive Disorder

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

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.

Study Overview

• Status: Unknown
• Conditions: Psychotherapy Intervention Evaluation
• Intervention / Treatment: Behavioral: Cognitive-bahavioral psychotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based psychotherapy	Behavioral: Cognitive-bahavioral psychotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
Impairment by OCD symptoms	assessed by App	Every day throughout the therapy process (14 weeks)
Extend of avoidance behavior	assessed by App	Every day throughout the therapy process (14 weeks)
Daily mood	assessed by App	Every day throughout the therapy process (14 weeks)
How the day was	assessed by App	Every day throughout the therapy process (14 weeks)
How strong OCD is	assessed by App	Every week throughout the therapy process (14 weeks)
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)
Anxiety ratings during exposures	assessed by App	Every week three days beginning with session 4 up to 14
Heart rate variability	assessed with wristband	Every day throughout the therapy (14 weeks)
Skin conductance level	assessed with wristband	Every day throughout the therapy (14 weeks)
Body temperature	assessed with wristband	Every day throughout the therapy (14 weeks)
Body movements	assessed with wristband	Every day throughout the therapy (14 weeks)

Collaborators and Investigators

• Sponsor: University Hospital Tuebingen

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: November 7, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimate): November 28, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 25, 2016
• Last Verified: November 1, 2016

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: F.1331477