- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283419
Predictors of rTMS and Group Therapy Efficacy in Adolescent Depression
Family Environment and Cognitive Function as Predictors of Efficacy for rTMS Combined With Group Therapy in Adolescent Depression: A Prospective Cohort Study
Study Overview
Status
Detailed Description
Adolescent depression is a significant health concern, and while combined therapies involving neuromodulation and psychotherapy show promise, individual treatment responses vary heterogeneity. This prospective cohort study enrolled 163 adolescents aged 12-18 with MDD. All participants received a standardized 4-week intervention consisting of 20 sessions of high-frequency (10 Hz) rTMS over the left dorsolateral prefrontal cortex (DLPFC) and 8 sessions of group Cognitive Behavioral Therapy (CBT).
Baseline assessments included the Family Environment Scale (FES) and a neuropsychological battery including the Stroop Color-Word Test and Wisconsin Card Sorting Test (WCST). The primary outcome was the percentage reduction in depressive symptoms measured by the HAMD-24 scale. The study employs multiple linear regression to determine which baseline factors independently predict superior treatment outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hebei
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Shijiazhuang, Hebei, China, 050000
- The First Hospital of Hebei Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Primary diagnosis of Major Depressive Disorder (MDD) according to ICD-10 criteria.
- Score of ≥ 20 on the 24-item Hamilton Depression Rating Scale (HAMD-24).
- Sufficient intellectual and linguistic ability to complete assessments and participate in therapy.
- Provided written informed consent (participants and guardians).
Exclusion Criteria:
- Lifetime diagnosis of a psychotic or bipolar disorder.
- Current substance use disorder.
- Significant neurological illness (e.g., epilepsy) or metallic implants contraindicated for rTMS.
- Receiving concurrent formal psychotherapy outside the study protocol.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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rTMS + Group Therapy Cohort
Adolescents diagnosed with MDD who received the standardized combined intervention.
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High-frequency (10 Hz) rTMS applied over the left dorsolateral prefrontal cortex (DLPFC), administered 5 days per week for 4 weeks (20 sessions total).
Manualized group therapy sessions focused on psychoeducation, cognitive restructuring, emotion regulation, and interpersonal skills, held twice weekly for 4 weeks (8 sessions total).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Percentage Reduction in HAMD-24 Score
Time Frame: Baseline and Week 4
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Treatment efficacy is defined as the percentage reduction in the 24-item Hamilton Depression Rating Scale (HAMD-24) score from baseline to the end of treatment.
The formula used is: [(HAMD-24 at Baseline - HAMD-24 at Week 4) / HAMD-24 at Baseline] × 100%.
The HAMD-24 assesses the severity of depressive symptoms, with higher scores indicating more severe depression.
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Baseline and Week 4
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023S00133
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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