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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Adjustment Impairment, Accident, Adjustment Disorders, Mental Disorder

Intervention / Treatment
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* Behavioral: Internet-based self-help


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based self-help<br>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<br>* Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.<br>|
| No Intervention: Waiting control group<br>Access to internet-based intervention after 12 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) | 21-item questionnaire assessing depression, anxiety and stress symptoms | 7 minutes | 

Secondary Outcome Measures

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