Clinical trial NCT02973932: iCBT for Children and Adolescents With Obsessive-compulsive Disorder
Official title: Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotherapy Intervention Evaluation
Keywords: cognitive-behavioral psychotherapy
obsessive-compulsive disorder
internet-based
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
timeFrame: beginning of the study and end therapy (about 16 weeks)
measure: The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: beginning of the study and end therapy (about 16 weeks)
measure: Children's Global Assessment Scale (CGAS)
timeFrame: beginning of the study and end therapy (about 16 weeks)
measure: Child Behavior Checklist (CBCL)
timeFrame: beginning of the study and end therapy (about 16 weeks)
measure: Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
timeFrame: beginning of the study and end therapy (about 16 weeks)
measure: Impairment by OCD symptoms
timeFrame: Every day throughout the therapy process (14 weeks)
measure: Extend of avoidance behavior
timeFrame: Every day throughout the therapy process (14 weeks)
measure: Daily mood
timeFrame: Every day throughout the therapy process (14 weeks)
measure: How the day was
timeFrame: Every day throughout the therapy process (14 weeks)
measure: How strong OCD is
timeFrame: Every week throughout the therapy process (14 weeks)
measure: How Every week throughout the therapy processgood e progress was with specific treatment goals
timeFrame: Every week throughout the therapy process (14 weeks)
measure: Anxiety ratings during exposures
timeFrame: Every week three days beginning with session 4 up to 14
measure: Heart rate variability
timeFrame: Every day throughout the therapy (14 weeks)
measure: Skin conductance level
timeFrame: Every day throughout the therapy (14 weeks)
measure: Body temperature
timeFrame: Every day throughout the therapy (14 weeks)
measure: Body movements
timeFrame: Every day throughout the therapy (14 weeks)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Child and Adolescent Psychiatry University of Tübingen
name: Annette Conzelmann, PhD
role: PRINCIPAL_INVESTIGATOR
References: