- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07469358
iCBT for Adolescents Obsessive-compulsive Dissorder
Taking Psychiatry Online: Developing a Platform to Provide Internet-Delivered Cognitive-Behavior Therapy and Testing It in Pediatric Obsessive-Compulsive Disorder
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although cognitive-behavior therapy (CBT) is a well-established first-line treatment for many mental disorders, very few patients receive it due to the shortage of trained professionals, the costs of face-to-face therapy, and geographic barriers. Therapist-guided internet-delivered CBT (iCBT) is a potential solution to this problem but is not generally available in our context.
The investigators plan to:
- Develop a digital platform for the treatment of mental disorders using therapist-guided iCBT;
- Assess the feasibility, acceptability, and potential effects of therapist-guided iCBT for adolescent obsessive-compulsive disorder (OCD) using the platform developed in Objective 1.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Barcelona
-
Barcelona, Barcelona, Spain, 08036
- Hospital Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 12 and 17
- Internet access
- Principal diagnosis of OCD, based on DSM-5
- Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) Total Severity Score > 16
- Ability to communicate in Spanish
- For participants taking psychotropic medication for OCD: at least eight weeks on stable medication and willingness to stay on the same medication/doses for the 14 weeks of the study
Exclusion Criteria:
- Estimated IQ < 70, as per the Vocabulary subtest of the Wechsler Intelligence Scale for Children (WISC)
- Eight or more previous sessions of CBT for OCD with an experienced therapist during the last 12 months
- Ongoing psychological treatment for OCD
- Diagnosis of organic brain disorder, intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, low-weight anorexia nervosa, or alcohol/substance dependence
- Immediate risk to self or others (e.g., suicidality)
- Inability to communicate in Spanish
- Low motivation to participate (i.e., the patient does not believe the therapy will be helpful at all)
- Insufficient time to work on the treatment (about 60 minutes per day)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental: Interned-delivered Cognitive-Behavioral Therapy (CBT)
|
14-Week Therapist-Based iCBT for pediatric OCD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility (recruitment and retention rates and therapist burden)
Time Frame: Baseline and at week 14
|
The investigators will assess feasibility by recording recruitment rates, retention rates, and therapist burden (time spent by the therapist sending emails, reviewing materials, etc.).
|
Baseline and at week 14
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptability (Treatment Acceptability/Adherence Scale, TAAS)
Time Frame: Baseline and at week 14
|
The TAAS assesses satisfaction with treatment and adherence.
|
Baseline and at week 14
|
|
Child Yale-Brown Obsessive-Compulsive Scale
Time Frame: Baseline and week 14
|
The Child Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) evaluates the severity of obsessive-compulsive disorder symptoms in adolescents.
It is a clinician-rated, 10-item scale, with each item rated from 0 (no symptoms) to 4 (extreme symptoms), resulting in a total score ranging from 0 to 40.
The scale also provides separate subtotals for the severity of obsessions and compulsions.
|
Baseline and week 14
|
|
Clinical Global Impression (CGI)-Severity
Time Frame: Baseline and at week 14
|
The CGI rates the severity of the patient's illness at the time of assessment on a 7-point scale, from 1 = normal to 7 = among the most extremely ill patients.
|
Baseline and at week 14
|
|
Children's Depression Inventory
Time Frame: Baseline and at week 14
|
The CDI assesses the severity of depressive symptoms in adolescents (12-16).
|
Baseline and at week 14
|
|
Beck Depression Inventory
Time Frame: Baseline and at week 14
|
The BDI assesses the severity of depressive symptoms in adolescents (17 years old) and adults.
|
Baseline and at week 14
|
|
Negative Effects Questionnaire (NEQ)
Time Frame: Baseline and at week 14
|
The NEQ assesses potential negative side effects of the intervention.
|
Baseline and at week 14
|
|
Obsessive-Compulsive Inventory Child Version (OCI-CV)
Time Frame: Baseline and at week 14
|
The OCI-R assesses obsessive-compulsive symptoms experienced over the past month.
It is an 21-item self-report questionnaire covering six symptom dimensions: washing, checking, ordering, obsessing, hoarding, and neutralizing.
Each item is rated on a 3-point scale (0 = not at all, 1= sometimes, 2 = always), reflecting the distress caused by the symptom during the past month.
|
Baseline and at week 14
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCB/2023/0284 (Other Identifier: Hospital Clínic of Barcelona)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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