Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT

NCT06659094 | Completed

• 1 other identifier: 2024-TX-004
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to explore the efficacy and cost-effectiveness of stepped-care internet-based cognitive behavior therapy (sc-ICBT) with reduced support compared to cognitive-behavioral group therapy(CBGT), to identify the optimal transition points for shorter effective stepped treatments, to find clinical indicators that can predict the effectiveness of CBT interventions, and to investigate predictive outcomes. The main questions the investigators aim to answer are:

1. 1.Is the reduction in YBOCS scores following stepped-care Internet-based cognitive-behavioral therapy (SC-ICBT) with reduced support non-inferior to that observed in traditional cognitive-behavioral group therapy (CBGT)?
2. 2.Does SC-ICBT for obsessive-compulsive disorder offer better health economic benefits compared to CBGT?
3. 3.What is the optimal time point for transitioning to shorter effective stepped care, and what clinical indicators can predict the efficacy of CBT interventions post-treatment?

Conditions

Obsessive Compulsive Disorder (OCD)

Keywords

Obsessive Compulsive Disorder; Reduced-intensity stepped-care Internet-based Cognitive Behavioral Therapy; Randomized Controlled Trial; Cost effectiveness; Clinical Predictor

Outcome Measures

Primary Outcomes (1)

• Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)

  YBOCS is compiled by Goodman in the United States and contains 10 items to assess the severity of obsessive thoughts and compulsive behavior. The scoring method adopts a five-point scale of 0-4 points, and the total score range is 0-40 points, which has good reliability and validity. Scores below 16 are considered mild or subclinical, 16 to 23 points indicate moderate severity, 24 to 31 points indicate severe severity, and scores above 31 indicate extremely severe.

  Change from Baseline at 6 weeks

Secondary Outcomes (4)

• Change of Florida Obsessive-Compulsive Inventory (FOCI)

  Change from Baseline at 6 weeks

• Change of Self-rating Depression Scale (SDS)

  Change from Baseline at 6 weeks

• Change of Self-rating Anxiety Scale (SAS)

  Change from Baseline at 6 weeks

• The University of Rhode Island Change Assessment

  Change from Baseline at 6 weeks

Other Outcomes (11)

• Short-Form 6-Dimension Health Survey Version 2 (SF-6Dv2)

  Change from Baseline at 6 weeks

• Cost-effectiveness analysis

  The cost from Baseline to Week 6

• Cost-utility analysis

  The cost from Baseline to Week 6

Study Arms (2)

stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication

EXPERIMENTAL

Patients' OCD severity is initially assessed with the Yale-Brown Obsessive Compulsive Scale (YBOCS). After enrollment, patients receive health education, observe symptoms, learn ERP theory, and create exposure lists on a WeChat mini-program for pre-treatment. They perform daily 1-hour ERP exercises for a week, with online status collection by coordinators. After a week, patients receive twice-weekly online ERP guidance from therapists for two weeks. After two and four therapy sessions, YBOCS re-evaluations occur via Tencent Meeting. Based on scores, the next three weeks involve either self-guided ERP or a mix of self-guided and therapist-guided ERP. If patients show over a 25% reduction, therapist guidance is suspended, and they switch to self-guided ICBT for the final three weeks.

Other: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT); Drug: conventional medical treatment (TAU)

Cognitive Behavioral Group Therapy (CBGT) combined with medication

ACTIVE COMPARATOR

OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have. A nationally registered psychotherapist, who has undergone systematic professional training, is in charge of a homogeneous closed group and records the sessions live. The treatment takes place in the group psychotherapy room at the Shanghai Mental Health Center, with a group of 6 people, for 6 weeks, twice a week, each session lasting 2 hours. A senior domestic group cognitive therapist supervises the treatment.

Other: Cognitive Behavioral Group Therapy (CBGT); Drug: conventional medical treatment (TAU)

Interventions

stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) OTHER

Using a WeChat mini-program, we offer personalized OCD SC-ICBT remote services. Training is customized based on individual assessments, focusing on psychological education and homework to simulate CBT therapy. If a patient's YBOCS score drop from baseline isn't 25% after four therapist sessions (one week of theory, two sessions/week), they get three more weeks of online guidance. The program includes four structured lessons over six weeks: Lesson 1: Psychological Health Education on OCD and related disorders. Lesson 2: ERP theory, exposure item lists, and related info. Lesson 3: Daily ERP practice for about an hour, followed by two weeks of therapist guidance. Lesson 4: Retrospection and relapse prevention.

stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication

Cognitive Behavioral Group Therapy (CBGT) OTHER

The CBGT group will receive cognitive-behavioral group therapy for 6 weeks, twice a week, each session lasting 2 hours, at the Shanghai Mental Health Center. The CBGT program follows a structured process for treating OCD. During the prep phase, therapists assess patients for 50 minutes, collect data, and set CBGT groundwork. In Session 1, families join to understand CBGT, with goals reinforced and OCD education provided. Session 2 reviews homework and develops ERP strategies. Session 3 initiates ERP practice. Sessions 4-11 continue homework review and group ERP practice. The final session involves families in a review, discussing challenges, celebrating achievements, and focusing on relapse prevention.

Cognitive Behavioral Group Therapy (CBGT) combined with medication

conventional medical treatment (TAU) DRUG

Drug therapy, managed by a deputy chief psychiatrist unaware of patient groupings, utilizes China Food and Drug Administration (CFDA)-approved SSRIs for OCD. These include fluoxetine, paroxetine, sertraline, fluvoxamine, and others, with tricyclic drugs like clomipramine and SNRIs such as venlafaxine. The maximum dosage adheres to the instructions. Benzodiazepines may assist with sleep, but usage is capped at two weeks; no other psychotropics are co-administered. Common side effects comprise dry mouth, constipation, nausea, indigestion, dizziness, fatigue, and sweating. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.

Cognitive Behavioral Group Therapy (CBGT) combined with medication; stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medication

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 50 years, inclusive of both genders;
• Presenting primarily with compulsive symptoms that meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Obsessive-Compulsive Disorder (OCD);
• Yale-Brown Obsessive Compulsive Scale (YBOCS) scores ranging from 16 to 31, inclusive;
• Have been on a stable regimen of standard anti-compulsive pharmacotherapy for a period of 8 weeks;
• Possess a minimum educational level of junior high school;
• Demonstrate adequate auditory and visual acuity to perform the assessments required by the study;
• The participant and their legal guardian have comprehended the nature of the study and have provided informed consent;
• Right-handedness (this criterion applies exclusively to participants undergoing magnetic resonance imaging).

You may not qualify if:

• Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
• Obsessive-compulsive symptoms were too severe to participate in the experiment.
• High risk of suicide.
• Severe central system or physical disease
• Pregnant women or women that getting ready for being pregnant and lactating.
• Other treatments being performed.
• Uncooperative or unable to complete treatment
• With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Qing Fan, Doctor

  Shanghai Mental Health Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: August 21, 2023
• Primary Completion: August 21, 2025
• Study Completion: December 30, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

CN (1)