NCT07081438

Brief Summary

The goal of the study is to assess the feasibility, acceptability, and potential effects of therapist-guided internet-delivered cognitive-behavior therapy (iCBT) for adult obsessive-compulsive disorder, using a recently developed digital platform.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

July 10, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1.3 years

First QC Date

July 10, 2025

Last Update Submit

July 29, 2025

Conditions

Keywords

Obsessive-Compulsive DisorderCognitive-behavior therapyicbtOnline treatmente-health

Outcome Measures

Primary Outcomes (1)

  • Feasibility (recruitment and retention rates and therapist burden)

    The investigators will assess feasibility by recording recruitment rates, retention rates, and therapist burden (time spent by the therapist sending emails, reviewing materials, etc.).

    From enrollment to the end of treatment at 12 weeks

Other Outcomes (6)

  • Acceptability (Treatment Acceptability/Adherence Scale, TAAS)

    Immediately after the intervention

  • Yale-Brown Obsessive-Compulsive Scale

    Baseline and 12 weeks

  • Clinical Global Impression (CGI)-Severity

    Baseline and 12 weeks

  • +3 more other outcomes

Study Arms (1)

Internet-delivered Cognitive Behavioral Therapy (iCBT)

EXPERIMENTAL
Behavioral: icbt

Interventions

icbtBEHAVIORAL

12-Week Therapist-Based iCBT for OCD (Adapted Version of OCD Net: https://therapistguide.webcbt.se/index.html)

Internet-delivered Cognitive Behavioral Therapy (iCBT)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75
  • Internet access
  • Principal diagnosis of OCD, based on DSM-5
  • Yale-Brown Obsessive-Compulsive Scale (Y-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 12 weeks of the study

You may not qualify if:

  • Estimated IQ \< 70, as per the Vocabulary subtest of the Wechsler Adults 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 30 minutes per day)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Joaquim Radua, MD

    Instituto de Investigaciones Biomédicas August Pi i Sunyer (IDIBAPS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miquel A Fullana, PhD

CONTACT

Maria Sagué, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-Group Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2025

First Posted

July 23, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share