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CompletedNCT03785912SelFITUpdated Dec 14, 2021

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

An interventional study of Internet-based self-help in Adjustment Impairment, Accident and Adjustment Disorders, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-14.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Adjustment Impairment
  • Accident
  • Adjustment Disorders
  • Mental Disorder
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In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's enrollment of 23 is below the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Internet-based self-help

  • No intervention
    Waiting control group

    Access to internet-based intervention after 12 weeks.

Interventions

  • BehavioralInternet-based self-help

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

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What researchers measure

Primary outcomes

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

    21-item questionnaire assessing depression, anxiety and stress symptoms

    Time frame: 7 minutes

Secondary outcomes

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

    21-item questionnaire assessing depressive symptoms

    Time frame: 5-10 minutes

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

    20-item questionnaire assessing adjustment disorder symptoms and severity

    Time frame: 6 minutes

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

    12-item questionnaire assessing various aspects of well-being

    Time frame: 5 minutes

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

    10-item questionnaire assessing optimism and pessimism

    Time frame: 3 minutes

  5. BVI: Berner Verbitterungsinventar (Znoj, 2008)

    18-item questionnaire assessing embitterment

    Time frame: 3 minutes

  6. FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)

    24-item questionnaire assessing different aspects of work- and health-related topics

    Time frame: 5 minutes

  7. TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)

    58-item questionnaire assessing costs related to an accident

    Time frame: 20 minutes

  8. ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)

    8-item questionnaire assessing content with an online-program

    Time frame: 2 minutes

  9. SUS: System Usability Scale (Brooke, 1996)

    10-item questionnaire assessing usability of an online-program

    Time frame: 3 minutes

  10. SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)

    10-item questionnaire assessing general self-efficacy

    Time frame: 3 minutes

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Study locations

1 site
  • Universität Bern
    Bern, 3012, Switzerland
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References and documents

Publications

  • 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. PubMed 33331830 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03785912
Lead sponsor
University of Bern
Collaborators
Swiss Accident Insurance Fund SUVA
Responsible party
Sponsor
First posted
Dec 24, 2018
Start date
Dec 18, 2019
Primary completion
Nov 28, 2021
Completion
Nov 28, 2021
Last update
Dec 14, 2021

Study contacts

Hansjörg Znoj, Prof. Dr.
study director · University of Bern
Thomas Berger, Prof. Dr.
principal investigator · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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