| NCT ID | NCT06582225 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-11-25 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 220 participants in total. It began in 2024-11-25 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this trial is to evaluate the clinical efficacy, the cost-effectiveness and the effect durability of a therapist-guided, internet-delivered cognitive-behavior therapy intervention for obsessive-compulsive disorder (OCD) in children and adolescents with autism. A process evaluation of the treatment will also be conducted.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of autism, based on the diagnostic criteria of the 4th or 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM) or the 10th edition of the International Classification of Diseases (ICD-10). Informed by the parent/caregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report. A diagnosis of autism will be considered present if it was established with validated instruments, such as the Autism Diagnostic Interview-Revised (ADI-R), the Autism Diagnostic Observation Schedule (ADOS) edition 1 or 2 or the Diagnostic Interview for Social and Communication Disorders (DISCO; autism or ASD cut-offs). 2. A DSM-5 diagnosis of OCD. Confirmed by the assessor at the inclusion assessment, based on a structured diagnostic interview. 3. A total score of ≥16 on the CY-BOCS. Confirmed by the assessor at the inclusion assessment. 4. Age between 7 and 17 years. Confirmed by the caregiver and subsequently by the medical record system. 5. Ability to read and write Swedish. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment. 6. Regular access to a computer or a smartphone/tablet connected to the internet, and a mobile phone to receive text messages. Confirmed by the caregiver at the telephone screening or/and inclusion assessment. 7. A parent/caregiver able to participate in the treatment alongside their child. Confirmed by the caregiver at the telephone screening or/and the inclusion assessment. Exclusion Criteria: 1. Global intellectual disability. Informed by the parent/caregiver and subsequently confirmed by review of the medical record or the neurodevelopmental assessment report, and additionally estimated with the two subtests matrix reasoning and similarities from the Wechsler Intelligence Scale for Children - fifth edition (WISC-V) or Wechsler Adult Intelligence Scale - fourth edition (WAIS-IV). 2. Comorbid psychotic disorder, bipolar disorder, severe eating disorder, severe depression, alcohol/substance dependence or hoarding disorder. Confirmed by the caregiver at the telephone screening and subsequently by the assessor at the inclusion assessment based on the structured diagnostic interview and, if required, the medical record. 3. Current suicidal intent or a previous suicide attempt within the last 12 months. Confirmed by the assessor at the inclusion assessment and, if required, the medical record. 4. Main symptom presentation consists of hoarding symptoms. Confirmed by the assessor at the inclusion assessment. 5. Completed CBT for OCD within the last 12 months prior to the inclusion assessment (defined as at least 5 sessions of CBT including ERP). Confirmed by the caregiver at the telephone screening or/and inclusion assessment and, if required, the medical record. 6. Simultaneous psychological treatment for OCD or anxiety. Confirmed by the caregiver at the telephone screening and/or inclusion assessment. 7. Initiation, dosage change or cessation of medication for OCD (primarily selective serotonin reuptake inhibitors, SSRIs) or behavioural symptoms of ASD (atypical antipsychotics) within the 6 weeks prior to the baseline assessment. Confirmed by the caregiver at the telephone screening and the inclusion assessment and, if required, the medical record. 8. Having a close relationship to an already included participant (e.g., sibling, cousin), to avoid being randomised into two different arms, with the risk of information "leaking" between the groups. Confirmed by the caregiver or assessor at the telephone screening and/or at the inclusion assessment.
Contact & Investigator
David Mataix-Cols
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT06582225 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582225 currently recruiting?
Yes, NCT06582225 is actively recruiting participants. Contact the research team at david.mataix.cols@ki.se for enrollment information.
Where is the NCT06582225 trial being conducted?
This trial is being conducted at Lund, Sweden, Stockholm, Sweden, Gothenburg, Sweden.
Who is sponsoring the NCT06582225 clinical trial?
NCT06582225 is sponsored by Karolinska Institutet. The principal investigator is David Mataix-Cols at Karolinska Institutet. The trial plans to enroll 220 participants.