Obsessive-Compulsive DisorderNCT06621381
Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder
A study testing Concentrated exposure and response prevention in people with Obsessive-Compulsive Disorder, run by Uppsala University Hospital at 1 site in Sweden.
Trial summary
The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Concentrated exposure and response prevention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 11 Sep 2024to 14 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The patient fulfills the diagnostic criteria of obsessive-compulsive disorder
- The patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment
Who cannot join
- The patient/legal guardians are unable to communicate in Swedish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala, Region Uppsala, 751 85
Vendela Zetterqvist, Ph D, Associate Professor, +46 (0)768107060, vendela.zetterqvist@uu.se
About this study
Official title: A Single Group Evaluation of Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder
The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care.
The main question the study aims to answer is:
Read more
What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement?
Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format).
Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Concentrated exposure and response prevention
- Keywords
- Obsessive-compulsive disorder, Exposure, Response prevention, Pediatric, Cognitive Behavioral Therapy
- 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.
Concentrated exposure and response preventionBehavioural
Also called cognitive behavioral therapy
The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h)
| Study group | Role | What they receive |
|---|---|---|
| Concentrated exposure and response prevention | Experimental | The intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h) Receives: Behavioral: Concentrated exposure and response prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
The Childrens Yale-Brown Obsessive-Compulsive Scale is a semi-structured interview made up of 10 items rated on a 5-point Likert scale evaluating the severity of Obsessions and Compulsions across five dimensions; Frequency, Interference, Distress, Resistance, and Control, during the previous week and up to the time of interview. The total score varies between 0 and 40. Higher scores indicate higher severity of Obsessions and Compulsions.
Measured: pre-intervention; one week after the intervention; six months after the intervention
Secondary outcomes (5)
Clinical Global Impression (CGI)
The Clinical Global Impression is a brief, stand-alone assessment of the clinicians view of the patients global functioning prior to and after initiating treatment. It comprises two one-item measures evaluating (a) severity of psychopathology from 1 to 7 where a higher score indicates a higher severity, and (b) change from the initiation of treatment from 1 to 7, where a lower score indicates more improvement (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse)
Measured: pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Child Version (DOCS-CV)
The Dimensional Obsessive-Compulsive Scale - Child Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.
Measured: pre-intervention; one week after the intervention; six months after the intervention
The Obsessive Compulsive Inventory-Child Version (OCI-CV)
A 21-item self-report measure that assesses obsessive compulsive symptoms in children and adolescents aged 7 to 17 years over the preceding one month. It is a Likert-type rating scale, scored 0 to 2 (where 0 = never, 1 = sometimes and 2 = always). The total score varies between 0 and 42 where higher scores indicate more symptoms.
Measured: pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Parent Version (DOCS-PV)
The Dimensional Obsessive-Compulsive Scale - Parent Version is a 20-item self-report instrument that assesses the severity of Obsessive-Compulsive Disorder (OCD) symptoms along four empirically supported theme-based dimensions: (a) contamination, (b) responsibility for harm and mistakes, (c) incompleteness/symmetry, and (d) unacceptable (taboo) thoughts.over the preceding one month. The scale is developed for parents or legal guardians to children and adolescents aged 7 to 17 years. Within each subscale, the five item scores are summed to produce a subscale score (range = 0-20). The four subscale scores can be summed to produce an overall DOCS total score (range = 0-80). Higher score indicate higher severity of Obsessive-Compulsive Disorder.
Measured: pre-intervention; one week after the intervention; six months after the intervention
The Family Accommodation Scale for Obsessive Compulsive Disorder - Self-Rated Version (FAS-SR)
Parental assessment that aims to measure family members participation in or facilitation of rituals and/or avoidance in obsessive-compulsive disorder.
The first section consists of a symptom checklist for Obsessive Compulsive Disorder. The second section contains 19 items that examine the frequency of accommodating behaviors carried out by the relative. Each item is rated on a 5-point scale (0 = none/never, 4 = every day). The total score varies between 0 and 76 points. Higher scores indicate more family accommodation.
Measured: pre-intervention; one week after the intervention; six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start11 Sep 2024
- Primary completion14 Dec 2029 (estimated)
- Study completion14 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University
- Responsible party
- Principal investigator, Vendela Zetterqvist, Uppsala University Hospital
- Investigators
- Vendela Zetterqvist, Ph D, Associate Professor, Principal investigator, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06621381
- Sponsor's protocol ID
- 2023-07331-01
- Other IDs
- 2023
- Status last verified
- Sep 2024
- First submitted
- 9 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to restrictions in Swedish legislation
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Group Evaluation of Concentrated Exposure and Response Prevention for Children With Obsessive-compulsive Disorder
- ClinicalTrials.gov ID
- NCT06621381
- Acronym / sponsor ID
- 2023-07331-01
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-compulsive disorder, Exposure, Response prevention, Pediatric, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- Uppsala University
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 14 Dec 2029 (estimated)
- Study completion
- 14 Dec 2029 (estimated)
- First posted
- 1 Oct 2024 (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.
The goal of this clinical trial is to evaluate the preliminary outcomes of concentrated exposure and response prevention for children with obsessive-compulsive disorder (OCD) in regular clinical practice. It is a non-randomised open label evaluation where children 6-12 years with OCD who are patients at the Child and Adolescent Psychiatry (CAP) at Uppsala University Hospital will be rectruited together with their legal guardians. The treatment will be delivered by trained therapists in regular outpatient care.
The main question the study aims to answer is:
What are the preliminary treatment effects of concentrated exposure and response prevention with regards to OCD-symptoms, functional impact, family accomodation and clinician ratings of severity and improvement?
Participants will receive psychoeducation (in group format) and exposure and response prevention (9-12h concentrated to one week, individual format).
Outcomes will be measured on structured interviews, clinician ratings, and validated questionnaires pre-treatment, post-treatment and at a six month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Concentrated exposure and response prevention | Experimental | Behavioral: Concentrated exposure and response preventionThe intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- The patient fulfills the diagnostic criteria of obsessive-compulsive disorder
- The patient and the legal guardians have said yes to receiving the concentrated exposure with response prevention - treatment
Key exclusion criteria (1 listed)
- The patient/legal guardians are unable to communicate in Swedish
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 |
|---|---|---|
| Concentrated exposure and response preventionAlso: cognitive behavioral therapyThe intervention consists of: Psychoducation for the patients (1 session, 2-3h in group format), psychoeducation for the legal guardians (1 session, 3h in group format), exposure and response prevention (3-4 sessions, 9-12h over the course of one week, individual format), group reunions for sharing experiences, motivational work and relapse prevention ( 2 sessions, 3h) | Behavioural | Concentrated exposure and response prevention |
Primary outcome
Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
The Childrens Yale-Brown Obsessive-Compulsive Scale is a semi-structured interview made up of 10 items rated on a 5-point Likert scale evaluating the severity of Obsessions and Compulsions across five dimensions; Frequency, Interference, Distress, Resistance, and Control, during the previous week and up to the time of interview. The total score varies between 0 and 40. Higher scores indicate higher severity of Obsessions and Compulsions.
5 secondary outcomes
Clinical Global Impression (CGI)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Child Version (DOCS-CV)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
The Obsessive Compulsive Inventory-Child Version (OCI-CV)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
Dimensional Obsessive-Compulsive Scale - Parent Version (DOCS-PV)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
The Family Accommodation Scale for Obsessive Compulsive Disorder - Self-Rated Version (FAS-SR)
Time frame: pre-intervention; one week after the intervention; six months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: No. Due to restrictions in Swedish legislation
Related trials for Obsessive-Compulsive Disorder
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Family Accommodation Reduction in Adult Obsessive Compulsive Disorder
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Linear Accelerator Radiosurgical Anterior Capsulotomy With Task-based fMRI Identification of PERSonalized and PrEdictiVE Biomarkers of REsponse in Treatment-Refractory Obsessive-Compulsive Disorder (PERSEVERE Trial)
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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.
Vendela Zetterqvist, Ph D, Associate Professor principal investigator
Uppsala University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concentrated exposure and response prevention in people with Obsessive-Compulsive Disorder, run by Uppsala University Hospital at 1 site in Sweden.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 1 Oct 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vendela Zetterqvist, Ph D, Associate professor (+46 (0)768107060, vendela.zetterqvist@uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childrens Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) (time frame: pre-intervention; one week after the intervention; six months after the intervention). 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 1 Oct 2024.