Back to resultsiCBT for Children and Adolescents With Obsessive-compulsive Disorder
Primary Purpose
Psychotherapy Intervention Evaluation
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cognitive-bahavioral psychotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Psychotherapy Intervention Evaluation focused on measuring cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Internet-based psychotherapy
Arm Description
Outcomes
Primary Outcome Measures
The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Children's Global Assessment Scale (CGAS)
Child Behavior Checklist (CBCL)
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
Impairment by OCD symptoms
assessed by App
Extend of avoidance behavior
assessed by App
Daily mood
assessed by App
How the day was
assessed by App
How strong OCD is
assessed by App
How Every week throughout the therapy processgood e progress was with specific treatment goals
assessed by App
Anxiety ratings during exposures
assessed by App
Heart rate variability
assessed with wristband
Skin conductance level
assessed with wristband
Body temperature
assessed with wristband
Body movements
assessed with wristband
Secondary Outcome Measures
Full Information
NCT ID
NCT02973932
First Posted
November 7, 2016
Last Updated
November 25, 2016
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT02973932
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy Intervention Evaluation
Keywords
cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-based psychotherapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-bahavioral psychotherapy
Primary Outcome Measure Information:
Title
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)
Title
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame
beginning of the study and end therapy (about 16 weeks)
Title
Children's Global Assessment Scale (CGAS)
Time Frame
beginning of the study and end therapy (about 16 weeks)
Title
Child Behavior Checklist (CBCL)
Time Frame
beginning of the study and end therapy (about 16 weeks)
Title
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)
Title
Impairment by OCD symptoms
Description
assessed by App
Time Frame
Every day throughout the therapy process (14 weeks)
Title
Extend of avoidance behavior
Description
assessed by App
Time Frame
Every day throughout the therapy process (14 weeks)
Title
Daily mood
Description
assessed by App
Time Frame
Every day throughout the therapy process (14 weeks)
Title
How the day was
Description
assessed by App
Time Frame
Every day throughout the therapy process (14 weeks)
Title
How strong OCD is
Description
assessed by App
Time Frame
Every week throughout the therapy process (14 weeks)
Title
How Every week throughout the therapy processgood e progress was with specific treatment goals
Description
assessed by App
Time Frame
Every week throughout the therapy process (14 weeks)
Title
Anxiety ratings during exposures
Description
assessed by App
Time Frame
Every week three days beginning with session 4 up to 14
Title
Heart rate variability
Description
assessed with wristband
Time Frame
Every day throughout the therapy (14 weeks)
Title
Skin conductance level
Description
assessed with wristband
Time Frame
Every day throughout the therapy (14 weeks)
Title
Body temperature
Description
assessed with wristband
Time Frame
Every day throughout the therapy (14 weeks)
Title
Body movements
Description
assessed with wristband
Time Frame
Every day throughout the therapy (14 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annette Conzelmann, PhD
Phone
004970712987513
Email
annette.conzelmann@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annette Conzelmann, PhD
Organizational Affiliation
Department of Child and Adolescent Psychiatry University of Tübingen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
iCBT for Children and Adolescents With Obsessive-compulsive Disorder
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