Psychotherapy Intervention EvaluationNCT02973932
iCBT for Children and Adolescents With Obsessive-compulsive Disorder
A study testing Cognitive-bahavioral psychotherapy in people with Psychotherapy Intervention Evaluation, run by University Hospital Tuebingen.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Psychotherapy Intervention Evaluation
- What is being tested?
- Cognitive-bahavioral psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder
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.
- Conditions
- Psychotherapy Intervention Evaluation
- Being tested
- Cognitive-bahavioral psychotherapy
- Keywords
- cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-bahavioral psychotherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet-based psychotherapy | Experimental | Not described Receives: Behavioral: Cognitive-bahavioral psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
Measured: beginning of the study and end therapy (about 16 weeks)
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Measured: beginning of the study and end therapy (about 16 weeks)
Children's Global Assessment Scale (CGAS)
Measured: beginning of the study and end therapy (about 16 weeks)
Child Behavior Checklist (CBCL)
Measured: beginning of the study and end therapy (about 16 weeks)
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
Measured: beginning of the study and end therapy (about 16 weeks)
Impairment by OCD symptoms
assessed by App
Measured: Every day throughout the therapy process (14 weeks)
Extend of avoidance behavior
assessed by App
Measured: Every day throughout the therapy process (14 weeks)
Daily mood
assessed by App
Measured: Every day throughout the therapy process (14 weeks)
How the day was
assessed by App
Measured: Every day throughout the therapy process (14 weeks)
How strong OCD is
assessed by App
Measured: Every week throughout the therapy process (14 weeks)
How Every week throughout the therapy processgood e progress was with specific treatment goals
assessed by App
Measured: Every week throughout the therapy process (14 weeks)
Anxiety ratings during exposures
assessed by App
Measured: Every week three days beginning with session 4 up to 14
Heart rate variability
assessed with wristband
Measured: Every day throughout the therapy (14 weeks)
Skin conductance level
assessed with wristband
Measured: Every day throughout the therapy (14 weeks)
Body temperature
assessed with wristband
Measured: Every day throughout the therapy (14 weeks)
Body movements
assessed with wristband
Measured: Every day throughout the therapy (14 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotherapy Intervention EvaluationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Annette Conzelmann, University Hospital Tuebingen
- Investigators
- Annette Conzelmann, PhD, Principal investigator, Department of Child and Adolescent Psychiatry University of Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973932
- Sponsor's protocol ID
- F.1331477
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Psychotherapy for Children and Adolescents With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT02973932
- Acronym / sponsor ID
- F.1331477
- Conditions
- Psychotherapy Intervention Evaluation
- Keywords
- cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Internet-based psychotherapy | Experimental | Behavioral: Cognitive-bahavioral psychotherapy |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-bahavioral psychotherapy | Behavioural | Internet-based psychotherapy |
Primary outcome
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)
Children's Global Assessment Scale (CGAS)
Time frame: beginning of the study and end therapy (about 16 weeks)
Child Behavior Checklist (CBCL)
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)
Impairment by OCD symptoms
Time frame: Every day throughout the therapy process (14 weeks)
assessed by App
Extend of avoidance behavior
Time frame: Every day throughout the therapy process (14 weeks)
assessed by App
Daily mood
Time frame: Every day throughout the therapy process (14 weeks)
assessed by App
How the day was
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
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
Heart rate variability
Time frame: Every day throughout the therapy (14 weeks)
assessed with wristband
Skin conductance level
Time frame: Every day throughout the therapy (14 weeks)
assessed with wristband
Body temperature
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annette Conzelmann, PhD principal investigator
Department of Child and Adolescent Psychiatry University of Tübingen
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-bahavioral psychotherapy in people with Psychotherapy Intervention Evaluation, run by University Hospital Tuebingen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annette Conzelmann, PhD (004970712987513, annette.conzelmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.