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This document is a clinical trial protocol for a randomized controlled trial that explores participant satisfaction with the BUILD mobile application developed by Woebot Health. The study aims to
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How to fill out an exploratory randomized controlled

01
Define the research question and objectives for the study.
02
Identify the target population for the study.
03
Determine the sample size needed for statistical power.
04
Randomly assign participants to either the experimental group or control group.
05
Develop a clear protocol for the intervention being tested.
06
Ensure informed consent is obtained from all participants.
07
Collect baseline data on participants prior to intervention.
08
Implement the intervention according to the protocol.
09
Monitor participants for adherence and any adverse effects.
10
Collect follow-up data after the intervention to measure outcomes.
11
Analyze the data using appropriate statistical methods.
12
Interpret the results in the context of the initial research question.
13
Prepare a detailed report on the findings and implications.

Who needs an exploratory randomized controlled?

01
Researchers looking to understand the efficacy of a new treatment or intervention.
02
Clinicians seeking evidence-based practices to improve patient outcomes.
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Policy makers needing data to inform healthcare decisions.
04
Healthcare organizations aiming to evaluate new programs or protocols.
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Regulatory bodies that require evidence for approval of new therapies.
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An exploratory randomized controlled trial (RCT) is a type of study designed to evaluate the effectiveness of an intervention by randomly assigning participants to either the intervention group or a control group, typically without predefined hypotheses. It aims to explore associations or generate new hypotheses.
Researchers and institutions conducting exploratory randomized controlled trials are required to file the study, particularly if it involves human subjects and seeks funding or institutional review board (IRB) approval.
To fill out an exploratory randomized controlled, one should provide details about the study design, the hypothesis being tested, inclusion/exclusion criteria for participants, intervention methods, outcome measures, randomization techniques, and data analysis plans.
The purpose of an exploratory randomized controlled is to investigate potential effects of an intervention, identify promising treatment approaches, and generate insights that can inform future research which may have more defined hypotheses.
Information that must be reported includes the study title, objectives, background, methods (including randomization and blinding), participant characteristics, intervention details, primary and secondary outcomes, statistical methods, and any adverse events or outcomes.
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