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

NCT03785912 | Completed DMC

• 1 other identifier: 2018-01059
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Adjustment Impairment; Accident; Adjustment Disorders; Mental Disorder

Outcome Measures

Primary Outcomes (1)

• DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)

  21-item questionnaire assessing depression, anxiety and stress symptoms

  7 minutes

Secondary Outcomes (10)

• BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)

  5-10 minutes

• ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)

  6 minutes

• SF-12: Short Form Health Survey (Ware et al., 1996)

  5 minutes

• LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)

  3 minutes

• BVI: Berner Verbitterungsinventar (Znoj, 2008)

  3 minutes

Study Arms (2)

Internet-based self-help

EXPERIMENTAL

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

Waiting control group

NO INTERVENTION

Access to internet-based intervention after 12 weeks.

Interventions

Internet-based self-help BEHAVIORAL

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

Internet-based self-help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bern: lead
• Swiss Accident Insurance Fund SUVA: collaborator

Study Sites (1)

Universität Bern

Bern, 3012, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 33331830 DERIVED

MeSH Terms

Conditions

Adjustment Disorders; Mental Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders

Study Officials

• Hansjörg Znoj, Prof. Dr.

  University of Bern

  STUDY DIRECTOR

• Thomas Berger, Prof. Dr.

  University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: December 18, 2019
• Primary Completion: November 28, 2021
• Study Completion: November 28, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)