Efficacy, Safety, and Acceptability of Internet-based Cognitive Behavioral Therapy (NCT05554289) | Clinical Trial Compass
CompletedNot Applicable
Efficacy, Safety, and Acceptability of Internet-based Cognitive Behavioral Therapy
China315 participantsStarted 2023-04-21
Plain-language summary
This is a prospective, randomized, multicenter, double-blind, placebo-controlled phase III trial evaluating the efficacy and safety of WL-iCBT - a smartphone-based digital therapeutic combining cognitive behavioral therapy and attention bias modification. The study enrolls 315 participants aged 18-60 with mild-to-moderate MDD (MADRS score 18-30) across 11 clinical centers in China. Participants will be randomized to receive either active WL-iCBT or placebo software for 8 weeks, followed by a 26-week observational extension phase. Primary endpoint is change in MADRS score from baseline to Week 8. Secondary endpoints include treatment response rate, remission rate, anxiety symptoms (HAMA), functional impairment (SDS), and cognitive function (PDQ-D), and Clinical Global Impression rating scale (CGI). Safety monitoring includes AE/SAE recording and device deficiency assessment. Acceptability will be assessed by device performance evaluation.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Voluntary participation in the trial with signed informed consent
✓. Age 18-60 years (inclusive), any gender
✓. Clinical diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.7.0.2), with either single episode or recurrent episodes without psychotic features
✓. Montgomery-Asberg Depression Rating Scale (MADRS) score ≥18 and \<30 at screening
✓. No antidepressant medication within 2 weeks prior to screening (6 weeks for fluoxetine), and assessed by the investigator as able to maintain without antidepressant medication during the trial period
✓. Education level of primary school or above, able to understand the content of assessment scales, and proficient in using smartphones
Exclusion criteria
✕. Current clinical diagnosis meeting DSM-5 criteria for psychiatric disorders other than Major Depressive Disorder (confirmed by M.I.N.I.7.0.2)
What they're measuring
1
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score
. Treatment-resistant depression (defined as patients who failed to respond to adequate doses and duration (at least 4 weeks at maximum recommended dose) of 2 or more antidepressants with different chemical structures)
✕. History of alcohol and drug dependence
✕. Pregnant or lactating women, or men or women planning pregnancy during the clinical trial period
✕. Current serious physical disease, thyroid disease (thyroid stimulating hormone (TSH) exceeding the upper limit of normal at screening), or patients considered by investigators to have hypothyroidism or hyperthyroidism (at the investigator's discretion, laboratory tests meeting exclusion criteria may be rechecked once within the screening period)
✕. Obvious suicidal attempt or behavior, with a score ≥4 on item 10 "Suicidal Thoughts" of the MADRS scale
✕. Patients who have received other antidepressant treatments within 3 months prior to enrollment, including Chinese herbal medicine, modified electroconvulsive therapy, transcranial magnetic stimulation, biofeedback therapy, light therapy, acupuncture, and other physical or systematic psychological treatments
✕. Patients who explicitly express unwillingness to participate in psychological therapy or believe psychological therapy is ineffective