Protocol for a Randomized Trial Predicting CBT Efficacy for Depression

A study protocol document outlining a planned randomized trial to develop predictive models for cognitive behavioral therapy (CBT) efficacy in individuals with depressive symptoms. The protocol, authored by Jialing Ding and registered on ClinicalTrials.gov (NCT06631183), describes a study enrolling at least 1,500 adult participants in the U.S. starting January 23, 2024. The document details the methodology for collecting clinical, demographic, and behavioral task data to predict response to specific CBT interventions.

Use Cases

• Developing predictive algorithms for treatment response based on behavioral task variables and self-report data.
• Analyzing the relationship between learning propensities and efficacy of Cognitive Restructuring versus Behavioral Activation interventions.
• Studying longitudinal symptom change patterns based on assessments at 1, 6, 18, and 42 weeks post-intervention.
• Designing methodological frameworks for clinical trials with clean training/test dataset separation to prevent data leakage.

Strengths

• Study protocol is preregistered (ClinicalTrials.gov NCT06631183) and follows SPIRIT guidelines.
• Plans to recruit a substantial sample size of at least 1,500 participants.
• Methodology includes a clean 2:1 split for training and held-out test datasets to prevent data leakage.

Limitations

• The dataset is a 369.3 KB PDF protocol document; the actual clinical and behavioral data is not included.
• Column-level documentation is absent; field semantics must be inferred from the protocol description.
• Row count for the eventual data is unknown, which may limit suitability assessment.

Provenance

Source

Jialing Ding via figshare.

Collection Method

Planned data collection via online self-help tool, questionnaires, and behavioral tasks from recruited participants.

Time Range

Study enrollment started January 23, 2024.

Freshness

Last updated 2026-04-16 05:25:05; freshness should be verified.

Geography

Participants reside in the U.S.