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Clinical Trials/NCT02973932
NCT02973932
Unknown
N/A

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

University Hospital Tuebingen0 sites20 target enrollmentNovember 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Psychotherapy Intervention Evaluation
Sponsor
University Hospital Tuebingen
Enrollment
20
Primary Endpoint
Body movements
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
November 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Annette Conzelmann

PD Dr. Annette Conzelmann

University Hospital Tuebingen

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

Outcomes

Primary Outcomes

Body movements

Time Frame: Every day throughout the therapy (14 weeks)

assessed with wristband

How the day was

Time Frame: Every day throughout the therapy process (14 weeks)

assessed by App

Heart rate variability

Time Frame: Every day throughout the therapy (14 weeks)

assessed with wristband

Impairment by OCD symptoms

Time Frame: Every day throughout the therapy process (14 weeks)

assessed by App

Body temperature

Time Frame: Every day throughout the therapy (14 weeks)

assessed with wristband

Children's Global Assessment Scale (CGAS)

Time Frame: beginning of the study and end therapy (about 16 weeks)

The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)

Time Frame: beginning of the study and end therapy (about 16 weeks)

The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

Time Frame: beginning of the study and end therapy (about 16 weeks)

Extend of avoidance behavior

Time Frame: 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

Time Frame: Every week throughout the therapy process (14 weeks)

assessed by App

Anxiety ratings during exposures

Time Frame: Every week three days beginning with session 4 up to 14

assessed by App

Child Behavior Checklist (CBCL)

Time Frame: beginning of the study and end therapy (about 16 weeks)

Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)

Time Frame: beginning of the study and end therapy (about 16 weeks)

Daily mood

Time Frame: Every day throughout the therapy process (14 weeks)

assessed by App

How strong OCD is

Time Frame: Every week throughout the therapy process (14 weeks)

assessed by App

Skin conductance level

Time Frame: Every day throughout the therapy (14 weeks)

assessed with wristband

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