Clinical trial NCT06423443: Digital Cognitive Behavioral Therapy for Depressive Disorders
Official title: Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: Adai Technology (Beijing) Co., Ltd.
Sponsor class: OTHER
First posted: 2024-05-21
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.


Eligibility criteria: Inclusion Criteria:

1. Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient.
2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
3. Age ≥ 18 and ≤ 65 years, regardless of gender.
4. Understands the trial and signs the informed consent form.

Exclusion Criteria:

1. Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions.
2. History of substance and/or alcohol abuse within the past year.
3. Significant risk of suicide (MADRS item 10 score = 4).
4. Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
5. Inability to use a smartphone.
6. Deemed unsuitable for participation by the researcher.

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary outcomes:
measure: PHQ-9 (Patient Health Questionnaire-9)
timeFrame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
measure: GAD-7 (Generalized Anxiety Disorder-7)
timeFrame: baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
measure: Snaith-Hamilton Pleasure Scale (SHAPS)
timeFrame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
measure: Rumination Response Scale (RRS)
timeFrame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuang
Study officials:
References: