Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 3:54 AM
Study NCT ID:
NCT06659094
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Maximal Support in OCD: Efficacy of Stepped-Care Online CBT
Sponsor:
Shanghai Mental Health Center
Organization:
Study Overview
Official Title:
Step Down from Maximal Support: Efficacy of Stepped-care Internet-based Cognitive Behavior Therapy for Obsessive-compulsive Disorder
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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?
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: