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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03785912
Acronym
SelFIT
Enrollment
23
Registered
2018-12-24
Start date
2019-12-18
Completion date
2021-11-28
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accident, Adjustment Disorders, Adjustment Impairment, Mental Disorder

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.

Interventions

Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.

Sponsors

Swiss Accident Insurance Fund SUVA
CollaboratorUNKNOWN
University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)7 minutes21-item questionnaire assessing depression, anxiety and stress symptoms

Secondary

MeasureTime frameDescription
ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)6 minutes20-item questionnaire assessing adjustment disorder symptoms and severity
SF-12: Short Form Health Survey (Ware et al., 1996)5 minutes12-item questionnaire assessing various aspects of well-being
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)3 minutes10-item questionnaire assessing optimism and pessimism
BVI: Berner Verbitterungsinventar (Znoj, 2008)3 minutes18-item questionnaire assessing embitterment
BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)5-10 minutes21-item questionnaire assessing depressive symptoms
TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)20 minutes58-item questionnaire assessing costs related to an accident
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)2 minutes8-item questionnaire assessing content with an online-program
SUS: System Usability Scale (Brooke, 1996)3 minutes10-item questionnaire assessing usability of an online-program
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)3 minutes10-item questionnaire assessing general self-efficacy
FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)5 minutes24-item questionnaire assessing different aspects of work- and health-related topics

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026