Clinical trial NCT06659094: Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT
Official title: Step Down from Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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?

Detailed description: SC-ICBT is a therapy combining therapist-guided and semi-self-directed ICBT, with treatment plans adjusted based on patient symptoms. While it aims to be minimally restrictive and low-cost, research shows that low-intensity treatment may miss the mark for patients with severe symptoms or low motivation. High dropout rates and safety concerns are also noted. To address this, the investigators propose starting with high-intensity one-on-one support, reassessing symptoms in the third week, and switching to low-intensity self-guided practice if improvement is seen, otherwise continuing high-intensity support.

In our study, the investigators will conduct a stepped-care Internet-based Cognitive Behavioral Therapy (ICBT) intervention trial with reduced support intensity: Following baseline symptom assessment (Week 0), participants will be allocated to either an online therapy group or an in-person group therapy group. Considering practicality, the study will employ a partially randomized allocation method: for participants who are convenient for both treatment modalities, the investigators will use random numbers to randomly assign them to either the online therapy group or the in-person group therapy group; if participants can only attend one of the treatment groups, the investigators will allocate them based on their preference. The group assignment will be blinded to the assessors. The study will feature two groups for a controlled trial: the experimental group, stepped-care ICBT combined with medication; the control group, cognitive-behavioral group therapy combined with medication. This study is conducted to explore the efficacy and cost-effectiveness of sc-ICBT with reduced support compared to CBGT in China.

The investigators plan to recruit 80 patients and assign them to the SC-ICBT group and the CBGT group for a 6-week intervention, with a follow-up period of 3 months post-intervention. During this period, the investigators will employ questionnaires, scales, functional magnetic resonance imaging (fMRI), and other experimental methods to assess participants' obsessive-compulsive symptoms and treatment outcomes. Concurrently, the investigators will collect data on patients' economic burden and self-reported health status to evaluate the cost effect of SC-ICBT.

Eligibility criteria: Inclusion Criteria:

1. Individuals aged between 18 and 50 years, inclusive of both genders;
2. 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);
3. Yale-Brown Obsessive Compulsive Scale (YBOCS) scores ranging from 16 to 31, inclusive;
4. Have been on a stable regimen of standard anti-compulsive pharmacotherapy for a period of 8 weeks;
5. Possess a minimum educational level of junior high school;
6. Demonstrate adequate auditory and visual acuity to perform the assessments required by the study;
7. The participant and their legal guardian have comprehended the nature of the study and have provided informed consent;
8. Right-handedness (this criterion applies exclusively to participants undergoing magnetic resonance imaging).

Exclusion Criteria:

1. Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD.
2. Obsessive-compulsive symptoms were too severe to participate in the experiment.
3. High risk of suicide.
4. Severe central system or physical disease
5. Pregnant women or women that getting ready for being pregnant and lactating.
6. Other treatments being performed.
7. Uncooperative or unable to complete treatment
8. 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)

Primary outcomes:
measure: Change of Yale-Brown Obsessive-Compulsive Scale (YBOCS)
timeFrame: Change from Baseline at 6 weeks
Secondary outcomes:
measure: Change of Florida Obsessive-Compulsive Inventory (FOCI)
timeFrame: Change from Baseline at 6 weeks
measure: Change of Self-rating Depression Scale (SDS)
timeFrame: Change from Baseline at 6 weeks
measure: Change of Self-rating Anxiety Scale (SAS)
timeFrame: Change from Baseline at 6 weeks
measure: The University of Rhode Island Change Assessment
timeFrame: Change from Baseline at 6 weeks
Other outcomes:
measure: Short-Form 6-Dimension Health Survey Version 2 (SF-6Dv2)
timeFrame: Change from Baseline at 6 weeks
measure: Cost-effectiveness analysis
timeFrame: The cost from Baseline to Week 6
measure: Cost-utility analysis
timeFrame: The cost from Baseline to Week 6
measure: Dropout rate
timeFrame: From Baseline to Week 6
measure: Frequency of occurrence
timeFrame: From Baseline to Week 6
measure: Homework completion
timeFrame: From Baseline to Week 6
measure: Subjective satisfaction with treatment
timeFrame: From Baseline to Week 6
measure: Treatment safety
timeFrame: From Baseline to Week 6
measure: Change of randomized dot motion(RDM) perceptual decision-making task
timeFrame: Change from Baseline at 6 weeks
measure: Change of the antisaccade task
timeFrame: Baseline and Week 6
measure: Change of the task-state functional magnetic resonance imaging(fMRI) of the whole brain
timeFrame: Change from Baseline at 6 weeks
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Qing Fan, Doctor
role: STUDY_CHAIR
References: