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Completed

NCT Number: NCT03785912

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

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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Key information

Conditions

Adjustment Impairment Accident Adjustment Disorders Mental Disorder Mental Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universität Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 7 minutes

    21-item questionnaire assessing depression, anxiety and stress symptoms

Secondary outcomes

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

    Time frame: 5-10 minutes

    21-item questionnaire assessing depressive symptoms

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

    Time frame: 6 minutes

    20-item questionnaire assessing adjustment disorder symptoms and severity

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

    Time frame: 5 minutes

    12-item questionnaire assessing various aspects of well-being

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

    Time frame: 3 minutes

    10-item questionnaire assessing optimism and pessimism

  5. BVI: Berner Verbitterungsinventar (Znoj, 2008)

    Time frame: 3 minutes

    18-item questionnaire assessing embitterment

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

    Time frame: 5 minutes

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

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

    Time frame: 20 minutes

    58-item questionnaire assessing costs related to an accident

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

    Time frame: 2 minutes

    8-item questionnaire assessing content with an online-program

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

    Time frame: 3 minutes

    10-item questionnaire assessing usability of an online-program

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

    Time frame: 3 minutes

    10-item questionnaire assessing general self-efficacy

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • Swiss Accident Insurance Fund SUVA

Registry information

Official study 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

Acronym: SelFIT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 24, 2018
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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