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

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. 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. Does SC-ICBT for obsessive-compulsive disorder offer better health economic benefits compared to CBGT?
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)

Interventions

OTHER

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

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.

OTHER

Cognitive Behavioral Group Therapy (CBGT)

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.

DRUG

conventional medical treatment (TAU)

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.

Sponsors & Collaborators

• Shanghai Mental Health Center

  lead OTHER

Principal Investigators

• Qing Fan, Doctor · Shanghai Mental Health Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-21

Primary Completion

2025-08-21

Completion

2025-12-30

Countries

• China

Study Locations