SelFIT: Internet-based Treatment for Adjustment Problems After an Accident (SelFIT)

Randomized Controlled Trial (RCT) to Evaluate the Efficacy and Cost-effectiveness of an Internet-based Self-help Program for People With Adjustment Problems After an Accident

In this study, people who suffer from adjustment problems after having experienced an accident will be randomized to one of two study groups. The first group receives access to the internet-based self-help intervention immediately. The second group is a waiting control group that receives access to the program 12 weeks later. In both conditions additional care or treatment is allowed. The aim of the study is to investigate the efficacy and cost-effectiveness of an internet-based self-help intervention for people with adjustment problems after an accident compared to a waiting list. There are 6 assessments, which all take place online: baseline, two between-measurements (after 4 and 8 weeks), post assessment (after 12 weeks) and two follow-up assessments (after 3 and 6 months). All participants from both groups are asked to fill out all assessments.

Study Overview

• Status: Completed
• Conditions: Mental Disorder; Adjustment Disorders; Adjustment Impairment; Accident
• Intervention / Treatment: Behavioral: Internet-based self-help

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • Universität Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: All participants must...

• be at least 18 years old
• give a declaration of consent to participate in the study
• have access to the Internet
• understand and master the German language to the degree that they understand the contents and instructions of the study
• exceed the cut-off value for at least a mild psychological burden on the depression-anxiety stress scale (DASS- 21)
• be able to specify an emergency address in the event of an acute crisis
• have experienced and can specify an accident during a period of two weeks to two years prior to participation in the current study that lead to the conditions described above.

Exclusion Criteria: Excluded are persons who...

• show severe depressive symptoms (Beck depression inventory [BDI-II] > 29)
• show suicidal tendencies (BDI-II Suicide item > 1)
• have a known diagnosis of psychotic or bipolar disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based self-help; The self-help program consists of eight text- and video-based modules. All participants in this group receive immediate access to the self-help program. The program's self-management approach does not provide for regular support from a specialist. However, participants can contact the study team if they need or want additional help.	Behavioral: Internet-based self-help; Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.
No Intervention: Waiting control group; Access to internet-based intervention after 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)	21-item questionnaire assessing depression, anxiety and stress symptoms	7 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)	21-item questionnaire assessing depressive symptoms	5-10 minutes
ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)	20-item questionnaire assessing adjustment disorder symptoms and severity	6 minutes
SF-12: Short Form Health Survey (Ware et al., 1996)	12-item questionnaire assessing various aspects of well-being	5 minutes
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)	10-item questionnaire assessing optimism and pessimism	3 minutes
BVI: Berner Verbitterungsinventar (Znoj, 2008)	18-item questionnaire assessing embitterment	3 minutes
FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)	24-item questionnaire assessing different aspects of work- and health-related topics	5 minutes
TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)	58-item questionnaire assessing costs related to an accident	20 minutes
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)	8-item questionnaire assessing content with an online-program	2 minutes
SUS: System Usability Scale (Brooke, 1996)	10-item questionnaire assessing usability of an online-program	3 minutes
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)	10-item questionnaire assessing general self-efficacy	3 minutes

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: Swiss Accident Insurance Fund SUVA
• Investigators: Study Director: Hansjörg Znoj, Prof. Dr., University of Bern

Publications and helpful links

General Publications

• Hegy JK, Brog NA, Berger T, Znoj H. Web-based Self-help Program for Adjustment Problems After an Accident (SelFIT): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Dec 17;9(12):e21200. doi: 10.2196/21200.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2019
• Primary Completion (Actual): November 28, 2021
• Study Completion (Actual): November 28, 2021

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 20, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Mental Disorders; Adjustment Disorders
• Other Study ID Numbers: 2018-01059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No