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Clinical Trials/NCT02973932
NCT02973932UnknownNot Applicable

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

University Hospital Tuebingen0 sites20 target enrollmentStarted: November 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Primary Endpoint
Child Behavior Checklist (CBCL)

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
7 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Internet-based psychotherapy

Experimental

Intervention: Cognitive-bahavioral psychotherapy (Behavioral)

Outcomes

Primary Outcomes

Child Behavior Checklist (CBCL)

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

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

Body movements

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

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

Children's Global Assessment Scale (CGAS)

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

PD Dr. Annette Conzelmann

PD Dr. Annette Conzelmann

University Hospital Tuebingen

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