Psychotherapy Intervention EvaluationNCT05037344

iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

A study testing Cognitive-behavioral psychotherapy in people with Psychotherapy Intervention Evaluation, run by University Hospital Tuebingen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 18 years
Conditions the study is for: Psychotherapy Intervention Evaluation
What is being tested?: Cognitive-behavioral psychotherapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteGermany
Study dates: 4 Mar 2019to 30 Apr 2022
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 6 to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Hospital Tuebingen
Tübingen

Other trials in Germany

About this study

Official title: 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.

Read the 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).

Conditions: Psychotherapy Intervention Evaluation
Being tested: Cognitive-behavioral 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-behavioral psychotherapyBehavioural
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.

Study groups in NCT05037344
Study group	Role	What they receive
Internet-based psychotherapy	Experimental	16 weeks of internet-based cognitive behavioral therapy Receives: Behavioral: Cognitive-behavioral psychotherapy
Internet-based psychotherapy waiting group	Active comparator	16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks Receives: Behavioral: Cognitive-behavioral psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Interview/questionnaire for obsessive-compusive disorders.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Global Assessment Scale (CGAS)
The CGAS is a measure of level of functioning in children and adolescents.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Junior temperament and character inventory (JTCI)
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
The SCARED assesses DSM-IV anxiety symptoms.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Severity (CGI-S)
A clinical 7-point rating scale of symptom severity.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Improvement (CGI-I)
A clinical 7-point rating scale of symptom severity.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Impairment by OCD symptoms
Children and parents indicate impairment by OCD via app.
Measured: Every day throughout the therapy process
Change in Extend of avoidance behavior
Children and parents indicate extend of avoidance behavior via app.
Measured: Every day throughout the therapy process
Change in Daily mood
Children indicate their mood via app.
Measured: Every day throughout the therapy process
Change in How the day has been
Children indicate how good the day has been via app.
Measured: Every day throughout the therapy process
Change in How strong OCD is
Children and parants indicate how strong OCD is via app.
Measured: Every day throughout the therapy process
Change in How the week has been
Children and parants indicate how the week has been via app.
Measured: weekly throughout the therapy process
Change in Anxiety ratings during exposures
Children indicate how high anxiety was during exposures via app.
Measured: Every exposure throughout the therapy process
Change in Heart rate variability
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Measured: Every day throughout the therapy process
Change in time the OCD takes
Children and parants indicate how much time OCD takes via app.
Measured: Every day throughout the therapy process
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
This questionnaire assesses the core personality traits of children.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Engagement- Fragebogen
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in How convinced the patient of his/her OCD thoughts is
assessed by App
Measured: every exposure
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.
Measured: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 201930 Apr 2022

First posted8 Sep 2021
Study start4 Mar 2019
Primary completion30 Apr 2022
Study completion30 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05037344
Sponsor's protocol ID: AZ 53-5400.1-004/44
Status last verified: Jul 2022
First submitted: 31 Jul 2021
Last updated: 8 Jul 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We share study matterial and statistical outputs.

Publications

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.
PubMed 36329915
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.
PubMed 35189937

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Skills Video Intervention for Chinese/Chinese Americans
Emotion Regulation, Self Efficacy
Recruiting
Study on a Digital Ultra-Brief Intervention During Wait Times for Psychotherapy
Depressive Disorders, Anxiety Disorders
Recruiting
Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming
Loneliness, Social Isolation
Recruiting
Psychological Treatment to Support the Consequences of Cognitive Impairment
Cognitive Impairment, Psychological
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia

All Psychotherapy Intervention Evaluation trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2022. 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 II
ClinicalTrials.gov ID: NCT05037344
Acronym / sponsor ID: AZ 53-5400.1-004/44
Conditions: Psychotherapy Intervention Evaluation
Keywords: cognitive-behavioral psychotherapy, obsessive-compulsive disorder, internet-based
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: University Hospital TuebingenUniversity, hospital or other
Study start: 4 Mar 2019 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 30 Apr 2022 (actual)
First posted: 8 Sep 2021 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Internet-based psychotherapy	Experimental	Behavioral: Cognitive-behavioral psychotherapy16 weeks of internet-based cognitive behavioral therapy
Internet-based psychotherapy waiting group	Active comparator	Behavioral: Cognitive-behavioral psychotherapy16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks

Who may qualify

Ages: 6 to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

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-behavioral psychotherapyThe 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.	Behavioural	Internet-based psychotherapy, Internet-based psychotherapy waiting group

Primary outcome

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Impairment by OCD symptoms
Time frame: Every day throughout the therapy process
Children and parents indicate impairment by OCD via app.
Change in Extend of avoidance behavior
Time frame: Every day throughout the therapy process
Children and parents indicate extend of avoidance behavior via app.
Change in Daily mood
Time frame: Every day throughout the therapy process
Children indicate their mood via app.
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.
Change in How strong OCD is
Time frame: Every day throughout the therapy process
Children and parants indicate how strong OCD is via app.
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.
Change in Anxiety ratings during exposures
Time frame: Every exposure throughout the therapy process
Children indicate how high anxiety was during exposures via app.
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.
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.
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.
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.
Change in How convinced the patient of his/her OCD thoughts is
Time frame: every exposure
assessed by App
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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
Derived from this study: PubMed 36329915Hollmann 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.
Derived from this study: PubMed 35189937Conzelmann 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.
Individual participant dataSharing planned: Yes. We share study matterial and statistical outputs.

Related trials for Psychotherapy Intervention Evaluation

Active, not recruiting
Skills Video Intervention for Chinese/Chinese Americans
Emotion Regulation, Self Efficacy
Recruiting
Study on a Digital Ultra-Brief Intervention During Wait Times for Psychotherapy
Depressive Disorders, Anxiety Disorders
Recruiting
Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming
Loneliness, Social Isolation
Recruiting
Psychological Treatment to Support the Consequences of Cognitive Impairment
Cognitive Impairment, Psychological
Recruiting
Talking for Change: Secondary Prevention of Child Sexual Abuse Perpetration
Pedophilia, Hebephilia

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-behavioral psychotherapy in people with Psychotherapy Intervention Evaluation, run by University Hospital Tuebingen at 1 site in Germany.

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 5 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05037344, which also lists 2 linked publications.

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 8 Jul 2022.