iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

July 6, 2022 updated by: PD Dr. Annette Conzelmann, University Hospital Tuebingen

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Internet-based psychotherapy
16 weeks of internet-based cognitive behavioral therapy
Behavioral: Cognitive-behavioral psychotherapy
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.
ACTIVE_COMPARATOR: Internet-based psychotherapy waiting group
16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks
Behavioral: Cognitive-behavioral psychotherapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Clinical interview for psychiatric disorders for children and parents.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Interview/questionnaire for obsessive-compusive disorders.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Global Assessment Scale (CGAS)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The CGAS is a measure of level of functioning in children and adolescents.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Behavior Checklist (CBCL/6-18R)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Youth Self-Report (YSR/11-18R)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Depression Inventory for Children and Adolescents (DIKJ)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Junior temperament and character inventory (JTCI)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
The SCARED assesses DSM-IV anxiety symptoms.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Severity (CGI-S)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A clinical 7-point rating scale of symptom severity.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Improvement (CGI-I)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
A clinical 7-point rating scale of symptom severity.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Impairment by OCD symptoms
Time Frame: Every day throughout the therapy process
Children and parents indicate impairment by OCD via app.
Every day throughout the therapy process
Change in Extend of avoidance behavior
Time Frame: Every day throughout the therapy process
Children and parents indicate extend of avoidance behavior via app.
Every day throughout the therapy process
Change in Daily mood
Time Frame: Every day throughout the therapy process
Children indicate their mood via app.
Every day throughout the therapy process
Change in How the day has been
Time Frame: Every day throughout the therapy process
Children indicate how good the day has been via app.
Every day throughout the therapy process
Change in How strong OCD is
Time Frame: Every day throughout the therapy process
Children and parants indicate how strong OCD is via app.
Every day throughout the therapy process
Change in How the week has been
Time Frame: weekly throughout the therapy process
Children and parants indicate how the week has been via app.
weekly throughout the therapy process
Change in Anxiety ratings during exposures
Time Frame: Every exposure throughout the therapy process
Children indicate how high anxiety was during exposures via app.
Every exposure throughout the therapy process
Change in Heart rate variability
Time Frame: Every day throughout the therapy process
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Every day throughout the therapy process
Change in time the OCD takes
Time Frame: Every day throughout the therapy process
Children and parants indicate how much time OCD takes via app.
Every day throughout the therapy process
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
This questionnaire assesses the core personality traits of children.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Engagement- Fragebogen
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in How convinced the patient of his/her OCD thoughts is
Time Frame: every exposure
assessed by App
every exposure
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
Time Frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Questionnaire to life quality of parents related to the impairment through the illness of the child.
baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trauma History Questionaire (THQ)
Time Frame: baseline
This is a 5-point scale and 28 items that measures trauma experience such as sexual abuse or emotional neglect.
baseline
Essener Trauma Inventory for Children and Adolescents (ETI-KJ)
Time Frame: baseline
This questionnaire measures posttraumatic symptoms.
baseline
Childhood trauma questionaire (CTQ)
Time Frame: baseline
This is a 24-item measure to traumatic events.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 4, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 31, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AZ 53-5400.1-004/44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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