Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jun 8, 2020
Open Peer Review Period: Jun 8, 2020 - Jul 7, 2020
Date Accepted: Nov 10, 2020
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Investigating the Efficacy and Cost-Effectiveness of a Web-based Self-help Program for People With Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial
ABSTRACT
Background:
Accidents and the resulting injuries are one of the world’s biggest health care issues often causing long-term effects on psychological and physical health. With regard to psychological consequences, accidents can cause a wide range of burdens including adjustment problems. Although adjustment problems are among the most frequent mental health problems, there are few specific interventions available. The newly developed program SelFIT aims to remedy this situation by offering a low-threshold web-based self-help intervention for psychological distress after an accident.
Objective:
The overall aim is to evaluate the efficacy and cost-effectiveness of the SelFIT program plus care as usual (CAU) compared to only care as usual. Furthermore, the program’s user friendliness, acceptance and adherence are assessed. We expect that the use of SelFIT is associated with a greater reduction in psychological distress, greater improvement in mental and physical well-being, and greater cost-effectiveness compared to CAU.
Methods:
Adults (n=240) showing adjustment problems due to an accident they experienced between 2 weeks and 2 years before entering the study will be randomized. Participants in the intervention group receive direct access to SelFIT. The control group receives access to the program after 12 weeks. There are 6 measurement points for both groups (baseline as well as after 4, 8, 12, 24 and 36 weeks). The main outcome is a reduction in anxiety, depression and stress symptoms that indicate adjustment problems. Secondary outcomes include well-being, optimism, embitterment, self-esteem, self-efficacy, emotion regulation, pain, costs of health care consumption and productivity loss as well as the program’s adherence, acceptance and user-friendliness.
Results:
Recruitment started in December 2019 and is ongoing.
Conclusions:
To the best of our knowledge, this is the first study examining a web-based self-help program designed to treat adjustment problems resulting from an accident. If effective, the program could complement the still limited offer of secondary and tertiary psychological prevention after an accident. Clinical Trial: ClinicalTrials.gov NCT03785912; https://clinicaltrials.gov/ct2/show/NCT03785912?cond=NCT03785912&draw=2&rank=1
Citation
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