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

Julia Katharina Hegy, Noemi Anja Brog, Thomas Berger, Hansjoerg Znoj, Julia Katharina Hegy, Noemi Anja Brog, Thomas Berger, Hansjoerg Znoj

Abstract

Background: Accidents and the resulting injuries are among 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 (German acronym: Selber wieder fit nach einem Unfall; "fit again after an accident") 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 CAU. Furthermore, the program's user-friendliness, acceptance, and adherence are assessed. We expect that the use of SelFIT will be 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) experiencing adjustment problems due to an accident they had between 2 weeks and 2 years before entering the study will be randomized into either the intervention or control group. 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 began in December 2019 and will continue at least until January 2021, with the option to extend this for another 6 months until July 2021. As of July 2020, 324 people have shown interest in participating, and 48 people have given their informed consent.

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 offerings for secondary and tertiary prevention of psychological distress after an accident.

Trial registration: ClinicalTrials.gov NCT03785912; https://ichgcp.net/clinical-trials-registry/NCT03785912.

International registered report identifier (irrid): DERR1-10.2196/21200.

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

Conflict of interest statement

Conflicts of Interest: None declared.

©Julia Katharina Hegy, Noemi Anja Brog, Thomas Berger, Hansjoerg Znoj. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 17.12.2020.

Figures

Figure 1
Figure 1
Flowchart of the SelFIT study design. CAU: care as usual.
Figure 2
Figure 2
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) figure to display the study’s schedule of enrolment, interventions, and assessments. BTM: between-measurement. CAU: care as usual.
Figure 3
Figure 3
Gantt chart displaying the study’s recruitment schedule and status of recruitment.

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