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

Mental Disorder Clinical Trial

— SelFIT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785912
• Other study ID #: 2018-01059
• Status: Completed
• Phase: N/A
• Start date: December 18, 2019
• Est. completion date: November 28, 2021

Study information

• Verified date: December 2021
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 28, 2021
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Accident
• Adjustment Disorders
• Adjustment Impairment
• Disease
• Mental Disorder
• Mental Disorders

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Universität Bern	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	Swiss Accident Insurance Fund SUVA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)	21-item questionnaire assessing depression, anxiety and stress symptoms	7 minutes
Secondary	BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)	21-item questionnaire assessing depressive symptoms	5-10 minutes
Secondary	ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)	20-item questionnaire assessing adjustment disorder symptoms and severity	6 minutes
Secondary	SF-12: Short Form Health Survey (Ware et al., 1996)	12-item questionnaire assessing various aspects of well-being	5 minutes
Secondary	LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)	10-item questionnaire assessing optimism and pessimism	3 minutes
Secondary	BVI: Berner Verbitterungsinventar (Znoj, 2008)	18-item questionnaire assessing embitterment	3 minutes
Secondary	FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)	24-item questionnaire assessing different aspects of work- and health-related topics	5 minutes
Secondary	TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)	58-item questionnaire assessing costs related to an accident	20 minutes
Secondary	ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)	8-item questionnaire assessing content with an online-program	2 minutes
Secondary	SUS: System Usability Scale (Brooke, 1996)	10-item questionnaire assessing usability of an online-program	3 minutes
Secondary	SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)	10-item questionnaire assessing general self-efficacy	3 minutes