iCBT for Children and Adolescents With Obsessive-compulsive Disorder

NCT02973932 | Unknown

• 1 other identifier: F.1331477
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychotherapy Intervention Evaluation

Keywords

cognitive-behavioral psychotherapy; obsessive-compulsive disorder; internet-based

Outcome Measures

Primary Outcomes (16)

• 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)

Study Arms (1)

Internet-based psychotherapy

EXPERIMENTAL

Behavioral: Cognitive-bahavioral psychotherapy

Interventions

Cognitive-bahavioral psychotherapy BEHAVIORAL

Internet-based psychotherapy

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Annette Conzelmann, PhD

  Department of Child and Adolescent Psychiatry University of Tübingen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annette Conzelmann, PhD

CONTACT

004970712987513; annette.conzelmann@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Annette Conzelmann

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: November 28, 2016
• Study Start: November 1, 2016
• Primary Completion: November 1, 2017
• Last Updated: November 28, 2016

Record last verified: 2016-11