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iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

Primary Purpose

Psychotherapy Intervention Evaluation

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive-behavioral psychotherapy
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

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

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children and adolescents (ages 6-18) 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
  • written informed content of the child and his caretaker
  • OCD as highest treatment priority

Exclusion Criteria:

  • IQ below 70
  • not speaking and understanding German
  • A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Sites / Locations

  • University Hospital Tuebingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Internet-based psychotherapy

Internet-based psychotherapy waiting group

Arm Description

16 weeks of internet-based cognitive behavioral therapy

16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks

Outcomes

Primary Outcome Measures

Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
Clinical interview for psychiatric disorders for children and parents.
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Interview/questionnaire for obsessive-compusive disorders.
Change in Children's Global Assessment Scale (CGAS)
The CGAS is a measure of level of functioning in children and adolescents.
Change in Child Behavior Checklist (CBCL/6-18R)
A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.
Change in Youth Self-Report (YSR/11-18R)
A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.
Change in Depression Inventory for Children and Adolescents (DIKJ)
The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.
Change in Junior temperament and character inventory (JTCI)
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
The SCARED assesses DSM-IV anxiety symptoms.
Change in Clinical Global Impressions-Severity (CGI-S)
A clinical 7-point rating scale of symptom severity.
Change in Clinical Global Impressions-Improvement (CGI-I)
A clinical 7-point rating scale of symptom severity.
Change in Impairment by OCD symptoms
Children and parents indicate impairment by OCD via app.
Change in Extend of avoidance behavior
Children and parents indicate extend of avoidance behavior via app.
Change in Daily mood
Children indicate their mood via app.
Change in How the day has been
Children indicate how good the day has been via app.
Change in How strong OCD is
Children and parants indicate how strong OCD is via app.
Change in How the week has been
Children and parants indicate how the week has been via app.
Change in Anxiety ratings during exposures
Children indicate how high anxiety was during exposures via app.
Change in Heart rate variability
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Change in time the OCD takes
Children and parants indicate how much time OCD takes via app.
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
This questionnaire assesses the core personality traits of children.
Change in Engagement- Fragebogen
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
Change in How convinced the patient of his/her OCD thoughts is
assessed by App
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
Questionnaire to life quality of parents related to the impairment through the illness of the child.

Secondary Outcome Measures

Full Information

First Posted
July 31, 2021
Last Updated
July 6, 2022
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT05037344
Brief Title
iCBT for Children and Adolescents With Obsessive-compulsive Disorder II
Official Title
Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder II
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 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. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.
Detailed Description
In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based psychotherapy
Arm Type
Experimental
Arm Description
16 weeks of internet-based cognitive behavioral therapy
Arm Title
Internet-based psychotherapy waiting group
Arm Type
Active Comparator
Arm Description
16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral psychotherapy
Intervention Description
The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.
Primary Outcome Measure Information:
Title
Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
Description
Clinical interview for psychiatric disorders for children and parents.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Description
Interview/questionnaire for obsessive-compusive disorders.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Children's Global Assessment Scale (CGAS)
Description
The CGAS is a measure of level of functioning in children and adolescents.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Child Behavior Checklist (CBCL/6-18R)
Description
A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
Description
A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
Description
A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Youth Self-Report (YSR/11-18R)
Description
A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Depression Inventory for Children and Adolescents (DIKJ)
Description
The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Junior temperament and character inventory (JTCI)
Description
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
Description
The SCARED assesses DSM-IV anxiety symptoms.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Clinical Global Impressions-Severity (CGI-S)
Description
A clinical 7-point rating scale of symptom severity.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Clinical Global Impressions-Improvement (CGI-I)
Description
A clinical 7-point rating scale of symptom severity.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Impairment by OCD symptoms
Description
Children and parents indicate impairment by OCD via app.
Time Frame
Every day throughout the therapy process
Title
Change in Extend of avoidance behavior
Description
Children and parents indicate extend of avoidance behavior via app.
Time Frame
Every day throughout the therapy process
Title
Change in Daily mood
Description
Children indicate their mood via app.
Time Frame
Every day throughout the therapy process
Title
Change in How the day has been
Description
Children indicate how good the day has been via app.
Time Frame
Every day throughout the therapy process
Title
Change in How strong OCD is
Description
Children and parants indicate how strong OCD is via app.
Time Frame
Every day throughout the therapy process
Title
Change in How the week has been
Description
Children and parants indicate how the week has been via app.
Time Frame
weekly throughout the therapy process
Title
Change in Anxiety ratings during exposures
Description
Children indicate how high anxiety was during exposures via app.
Time Frame
Every exposure throughout the therapy process
Title
Change in Heart rate variability
Description
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Time Frame
Every day throughout the therapy process
Title
Change in time the OCD takes
Description
Children and parants indicate how much time OCD takes via app.
Time Frame
Every day throughout the therapy process
Title
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
Description
This questionnaire assesses the core personality traits of children.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in Engagement- Fragebogen
Description
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Title
Change in How convinced the patient of his/her OCD thoughts is
Description
assessed by App
Time Frame
every exposure
Title
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
Description
Questionnaire to life quality of parents related to the impairment through the illness of the child.
Time Frame
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Other Pre-specified Outcome Measures:
Title
Trauma History Questionaire (THQ)
Description
This is a 5-point scale and 28 items that measures trauma experience such as sexual abuse or emotional neglect.
Time Frame
baseline
Title
Essener Trauma Inventory for Children and Adolescents (ETI-KJ)
Description
This questionnaire measures posttraumatic symptoms.
Time Frame
baseline
Title
Childhood trauma questionaire (CTQ)
Description
This is a 24-item measure to traumatic events.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children and adolescents (ages 6-18) 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 written informed content of the child and his caretaker OCD as highest treatment priority Exclusion Criteria: IQ below 70 not speaking and understanding German A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment
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
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We share study matterial and statistical outputs.
IPD Sharing Time Frame
Any time before and after completion of the study for 10 years.
IPD Sharing Access Criteria
Upon request.
Citations:
PubMed Identifier
36329915
Citation
Hollmann K, Hohnecker CS, Haigis A, Alt AK, Kuhnhausen J, Pascher A, Worz U, App R, Lautenbacher H, Renner TJ, Conzelmann A. Internet-based cognitive behavioral therapy in children and adolescents with obsessive-compulsive disorder: A randomized controlled trial. Front Psychiatry. 2022 Oct 18;13:989550. doi: 10.3389/fpsyt.2022.989550. eCollection 2022.
Results Reference
derived
PubMed Identifier
35189937
Citation
Conzelmann A, Hollmann K, Haigis A, Lautenbacher H, Bizu V, App R, Nickola M, Wewetzer G, Wewetzer C, Ivarsson T, Skokauskas N, Wolters LH, Skarphedinsson G, Weidle B, de Haan E, Torp NC, Compton SN, Calvo R, Lera-Miguel S, Alt A, Hohnecker CS, Allgaier K, Renner TJ. Internet-based psychotherapy in children with obsessive-compulsive disorder (OCD): protocol of a randomized controlled trial. Trials. 2022 Feb 21;23(1):164. doi: 10.1186/s13063-022-06062-w.
Results Reference
derived

Learn more about this trial

iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

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