Short and Intensive Treatment of Children and Adolescents With Obsessive-Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Short and Intensive Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria:
- Obsessive-Compulsive Disorder diagnosis
- Male and female patients from 8-18 years
- Good German language speaking skills
- IQ of at least 75
- At least four days' participation in the treatment/therapy week
- Written agreement after clear explanation
Exclusion Criteria:
- No complete participation in the intensive week treatment/therapy
Sites / Locations
- Psychiatric University Clinics, Department of Child and Adolescent PsychiatryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Group
Arm Description
Patients are treated based on the Cognitive Behavioral Psychotherapy. This includes individual and group sessions over one week.
Outcomes
Primary Outcome Measures
Symptoms severity of obsessive and compulsive symptoms in children and adolescents
The clinician-report questionnaire (BY-BOCS) contains 19 items designed to assess severity of obsessive and compulsive symptoms in children and adolescents.The test uses a 4-point scale to rate the severity of their obsessive compulsive behaviors. Higher score means a worse outcome.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04730011
Brief Title
Short and Intensive Treatment of Children and Adolescents With Obsessive-Compulsive Disorder
Official Title
Short and Intensive Treatment of Children and Adolescents With Obsessive-Compulsive Disorder - A Study to Evaluate the Effectiveness of an Intensive Treatment Week: "A Future Without Constraint"
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Susanne Walitza
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Obsessive-compulsive disorders are very damaging illnesses; they can already appear in childhood and adolescence and become extremely chronic. With an average prevalence from 1-3%, they are among the most common psychiatric disorders in children and adolescents. 40% of diagnosed children and young adults display persistent and increasingly chronic symptoms and O-C disorders are highly complex syndromes with broadly varying manifestations. They arise from obsessive thoughts (ideas/thoughts or impulses, often senseless or tortured, that impose themselves or intrude) and obsessive behavior (ritualized patterns that must be frequently repeated).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Patients are treated based on the Cognitive Behavioral Psychotherapy. This includes individual and group sessions over one week.
Intervention Type
Behavioral
Intervention Name(s)
Short and Intensive Treatment
Intervention Description
Intensive Treatment Week with behavioural psychotherapy
Primary Outcome Measure Information:
Title
Symptoms severity of obsessive and compulsive symptoms in children and adolescents
Description
The clinician-report questionnaire (BY-BOCS) contains 19 items designed to assess severity of obsessive and compulsive symptoms in children and adolescents.The test uses a 4-point scale to rate the severity of their obsessive compulsive behaviors. Higher score means a worse outcome.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obsessive-Compulsive Disorder diagnosis
Male and female patients from 8-18 years
Good German language speaking skills
IQ of at least 75
At least four days' participation in the treatment/therapy week
Written agreement after clear explanation
Exclusion Criteria:
- No complete participation in the intensive week treatment/therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
Phone
+41 (0)43 499 26 26
Email
susanne.walitza@puk.zh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
Organizational Affiliation
Sponsor GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric University Clinics, Department of Child and Adolescent Psychiatry
City
Zurich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Walitza, Prof. Dr. med. Dipl.-Psych.
Phone
+41 43 499 26 26
Email
susanne.walitza@puk.zh.ch
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short and Intensive Treatment of Children and Adolescents With Obsessive-Compulsive Disorder
We'll reach out to this number within 24 hrs