Effect of SC-ICBT for Adults With OCD：A Three-Arm Randomized Controlled Trial
A legfontosabb adatok
- Ki végzi
- Shanghai Mental Health Center
- Hol
- Kína1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 46 fő vett részt
- Kezdés
- 2022. szept. 1.
- Befejezés
- 2024. márc. 31.
- A vizsgálat típusa
- Beavatkozással járó, 3 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT)
- Cognitive Behavioral Group Therapy (CBGT)
- conventional medical treatment (TAU)
- A regiszteradat frissítve
- 2026. január 21.
- Miért állt le
- Main trial terminated after pilot trial: full randomization proved infeasible for nonlocal participants; baseline symptom-based allocation added confounding variable; comparison with CBGT alone was deemed sufficient to assess SC-ICBT effectiveness
Ki vehet részt
- Életkor
- 18 év – 50 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 16 feltétel megnézéseKevesebb
Ki vehet részt
- Age between 18 and 50 years
- Satisfied with the diagnostic criteria for OCD in DSM-5
- 16≤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
Ki nem vehet részt
- 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)
- Satisfied with the diagnostic criteria for a mental disorder in DSM-V other than OCD
- Severe central system or physical disease
- Obsessive-compulsive symptoms were too severe to participate in the experiment
- High risk of suicide
- Pregnant women or women that getting ready for being pregnant and lactating
- Other treatments being performed
- Uncooperative or unable to complete treatment
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A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 3 csoportja
- stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) combined with medicationA vizsgált kezelés
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.
Kezelés: stepped-care Internet-based cognitive behavioral therapy(SC-ICBT) és conventional medical treatment (TAU)
- Cognitive Behavioral Group Therapy (CBGT) combined with medicationMár használt kezelés, összehasonlításként
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.
Kezelés: Cognitive Behavioral Group Therapy (CBGT) és conventional medical treatment (TAU)
- conventional medical treatment (TAU)Már használt kezelés, összehasonlításként
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.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Effect of Stepped Care in Internet-Based Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder：A Three-Arm Randomized Controlled Trial
- A regiszteradat frissítve
- 2026. január 21.