Clinical trial NCT03785912: SelFIT: Internet-based Treatment for Adjustment Problems After an Accident
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Impairment
Accident
Adjustment Disorders
Mental Disorder
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss Accident Insurance Fund SUVA
First posted: 2018-12-24
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
timeFrame: 7 minutes
Secondary outcomes:
measure: BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)
timeFrame: 5-10 minutes
measure: ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)
timeFrame: 6 minutes
measure: SF-12: Short Form Health Survey (Ware et al., 1996)
timeFrame: 5 minutes
measure: LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
timeFrame: 3 minutes
measure: BVI: Berner Verbitterungsinventar (Znoj, 2008)
timeFrame: 3 minutes
measure: FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)
timeFrame: 5 minutes
measure: TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)
timeFrame: 20 minutes
measure: ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
timeFrame: 2 minutes
measure: SUS: System Usability Scale (Brooke, 1996)
timeFrame: 3 minutes
measure: SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Universität Bern
Study officials:
affiliation: University of Bern
name: Hansjörg Znoj, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: University of Bern
name: Thomas Berger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.