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Randomized Experiments

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
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Blinding

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.

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Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled

Julia Katharina Hegy¹, Noemi Anja Brog¹, Thomas Berger²

¹Department of Health Psychology and Behavioral Medicine, Institute of Psychology, University of Bern, Bern, Switzerland.

JMIR Research Protocols

|December 17, 2020

Summary

This study evaluates SelFIT, a web-based self-help program for psychological distress after accidents. The program aims to reduce adjustment problems and improve well-being, offering a new option for post-accident mental health care.

Keywords:

accidents adjustment problems e-mental health guidance on demand online psychological prevention psychological self-help study protocol web-based

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Area of Science:

Psychology
Digital Health
Public Health

Background:

Accidents cause significant psychological and physical health burdens, including adjustment problems.
Limited interventions exist for post-accident psychological distress.
SelFIT is a novel, low-threshold, web-based self-help program designed to address these issues.

Purpose of the Study:

Evaluate the efficacy and cost-effectiveness of the SelFIT program combined with care as usual (CAU) versus CAU alone.
Assess the user-friendliness, acceptance, and adherence of the SelFIT program.
Hypothesize greater reductions in psychological distress and improvements in well-being with SelFIT.

Main Methods:

Randomized controlled trial with 240 adults experiencing adjustment problems post-accident.
Intervention group receives immediate SelFIT access; control group receives access after 12 weeks.
Six measurement points assess primary outcomes (anxiety, depression, stress) and secondary outcomes (well-being, cost-effectiveness, adherence, etc.).

Main Results:

Recruitment initiated in December 2019, with ongoing enrollment.
As of July 2020, 324 individuals expressed interest, and 48 provided informed consent.
Study completion is anticipated by July 2021, with potential for extension.

Conclusions:

This is the first study to examine a web-based self-help program for accident-related adjustment problems.
If proven effective, SelFIT could significantly enhance secondary and tertiary prevention of psychological distress following accidents.
The program offers a scalable solution to complement existing mental health support services.