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

Not Applicable

Completed

• Conditions: Accident; Adjustment Impairment; Adjustment Disorders; Mental Disorder
• Interventions: Behavioral: Internet-based self-help

• Registration Number: NCT03785912
• Lead Sponsor: University of Bern

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-20
• Study First Posted: 2018-12-24
• Study Start: 2019-12-18
• Primary Completion: 2021-11-28
• Study Completion: 2021-11-28
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based self-help	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universität Bern; 🇨🇭 Bern, Switzerland