Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial

NCT05528224 | Terminated

• 1 other identifier: OCDICBT2022-36
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the efficacy and cost-effectiveness of stepped-care Internet-based cognitive behavioral therapy (SC-ICBT) compared with Cognitive Behavioral Group Therapy (CBGT) and conventional medical treatment (treatment as usual, TAU) in adults with obsessive-compulsive disorder (OCD) in China. The main questions it aims to answer are: question 1: Whether the efficacy of SC-ICBT is noninferior to CBGT and TAU for OCD? question 2: Whether SC-ICBT is more cost-effective than CBGT and TAU for OCD? Participants will receive treatment (SC-ICBT or CBGT or TAU) for 6 weeks. Prior to the main study, we conduct a non-randomized pilot study to explore the efficacy and cost-effectiveness of SC-ICBT related to CBGT for adults with OCD in China.

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive Disorder; Stepped-care Internet-based Cognitive Behavioral Therapy; Cost-effectiveness; Randomized Controlled Trial

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.

  Change from Baseline at 6weeks

Secondary Outcomes (3)

• Change of Florida Obsessive-Compulsive Inventory (FOCI)

  Change from Baseline at 6weeks

• Change of Self-rating Depression Scale (SDS)

  Change from Baseline at 6weeks

• Change of Self-rating Anxiety Scale (SAS)

  Change from Baseline at 6weeks

Other Outcomes (11)

• Change of 36-item Short Form Health Survey（SF-36）

  Change from Baseline at 6weeks

• Cost-effectiveness analysis

  the cost from Baseline to Week 6

• Cost-utility analysis

  the cost from Baseline to Week 6

Study Arms (3)

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

EXPERIMENTAL

In the main study, after individualized assessment（0 week and 3 week separately）, OCD patients will be provided with self-guided ICBT or therapist-guided ICBT through the severity of their symptoms flexibly while they will continue with the medications they already have. In the pilot study, 23 OCD patients will be assigned to SC-ICBT group based on their autonomous will. They will begin with self-guided ICBT, followed by an assessment of their treatment outcomes at week 3, with non-responders being escalated to a higher intensity of treatment, and additional therapist-guided ICBT in the following three weeks. During the 6-week treatment they will continue with the medications they already have.

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

In the main study, OCD patients will be provided with therapist-guided offline Cognitive Behavioral Group Therapy while they will continue with the medications they already have. In the pilot study, 23 OCD patients will be assigned to CBGT group based on their autonomous will. They will receive the same CBGT intervention as in the main study while they will continue with the medications they already have.

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

conventional medical treatment (TAU)

ACTIVE COMPARATOR

In the main study, OCD patients will be treated as usual. Namely, they will continue with the medications they already have. This group is not present in the pilot study, as both SC-ICBT group and CBGT group combines medications. We suppose that the mere use of SC-ICBT group compared to CBGT group (a commonly used psychotherapy in Chinese clinical practice) is sufficient to draw conclusions about the feasibility of SC-ICBT in in adults with OCD in China. However, in order to further validate the economic benefits of SC-ICBT, we chose to set TAU group in the main study.

Drug: conventional medical treatment (TAU)

Interventions

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

OCD patients will take part in four structured online lessons for 6 weeks. Lesson one: Psychological Health Education, including the knowledge about OCD, SUDs and other related information. Lesson two: Exposure and Response Prevention (ERP), including the knowledge about ERP, exposure item list and other related information. Lesson three: Practice of Exposure and Response Prevention. Patients are asked to perform ERP practice based on what they have learned previously: practice at least once a day, a day about one hour all together. On this basis, in the main study, patients with severe obsessive and compulsive symptoms(Y-BOCS≥24) will be provided with extra therapist-guided ICBT: twice a week, about an hour one time. While in the pilot study, non-responders at week 3(YBOCS score reduction rate\<25%) will be provided with extra therapist-guided ICBT. Lesson four: Practice retrospection and relapse prevention.

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

Cognitive Behavioral Group Therapy (CBGT) OTHER

OCD patients will be asked to come to Shanghai Mental Health Center to take part in the offline CBT group. Each group will be treated for 6 weeks, twice a week for 2 hours each time. The treatment was supervised by an experienced CBGT therapist. The structure of the course basically corresponds with the SC-ICBT group.

Cognitive Behavioral Group Therapy (CBGT) combined with medication

conventional medical treatment (TAU) DRUG

In this study, the investigators use selective serotonin reuptake inhibitors (SSRIs) approved by the State Food and Drug Administration (CFDA) for the treatment of OCD (i.e., fluoxetine, paroxetine, sertraline and fluvoxamine) as well as citalopram and escitalopram. The second-generation atypical antipsychotics may also be combined as a potentiator if the patient requires. The maximum dosage shall not exceed the maximum dosage prescribed in the instruction manual.

Cognitive Behavioral Group Therapy (CBGT) combined with medication; conventional medical treatment (TAU); 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:

• Age between 18 and 50 years
• Satisfied with the diagnostic criteria for OCD in DSM-5.
• ≤YBOCS score ≤31
• Taking medication stably for 8 weeks
• Education level ⩾6 years
• Has sufficient audiovisual skills to complete the necessary examinations for the study.
• Right-handed (this criterion is for fMRI subjects only)
• Subjects and their guardians understood the study and signed informed consent.

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: August 11, 2022
• First Posted: September 6, 2022
• Study Start: September 1, 2022
• Primary Completion: August 30, 2023
• Study Completion: March 31, 2024
• Last Updated: January 21, 2026

Record last verified: 2026-01

Locations

CN (1)