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

Primary Purpose

Adjustment Impairment, Accident, Adjustment Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Internet-based self-help
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universität Bern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Internet-based self-help

Waiting control group

Arm Description

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.

Access to internet-based intervention after 12 weeks.

Outcomes

Primary Outcome Measures

DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
21-item questionnaire assessing depression, anxiety and stress symptoms

Secondary Outcome Measures

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

Full Information

First Posted
December 20, 2018
Last Updated
December 13, 2021
Sponsor
University of Bern
Collaborators
Swiss Accident Insurance Fund SUVA
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1. Study Identification

Unique Protocol Identification Number
NCT03785912
Brief Title
SelFIT: Internet-based Treatment for Adjustment Problems After an Accident
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
November 28, 2021 (Actual)
Study Completion Date
November 28, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
Swiss Accident Insurance Fund SUVA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Impairment, Accident, Adjustment Disorders, Mental Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Internet-based self-help
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting control group
Arm Type
No Intervention
Arm Description
Access to internet-based intervention after 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Internet-based self-help
Intervention Description
Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.
Primary Outcome Measure Information:
Title
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
Description
21-item questionnaire assessing depression, anxiety and stress symptoms
Time Frame
7 minutes
Secondary Outcome Measure Information:
Title
BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)
Description
21-item questionnaire assessing depressive symptoms
Time Frame
5-10 minutes
Title
ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)
Description
20-item questionnaire assessing adjustment disorder symptoms and severity
Time Frame
6 minutes
Title
SF-12: Short Form Health Survey (Ware et al., 1996)
Description
12-item questionnaire assessing various aspects of well-being
Time Frame
5 minutes
Title
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
Description
10-item questionnaire assessing optimism and pessimism
Time Frame
3 minutes
Title
BVI: Berner Verbitterungsinventar (Znoj, 2008)
Description
18-item questionnaire assessing embitterment
Time Frame
3 minutes
Title
FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)
Description
24-item questionnaire assessing different aspects of work- and health-related topics
Time Frame
5 minutes
Title
TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)
Description
58-item questionnaire assessing costs related to an accident
Time Frame
20 minutes
Title
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
Description
8-item questionnaire assessing content with an online-program
Time Frame
2 minutes
Title
SUS: System Usability Scale (Brooke, 1996)
Description
10-item questionnaire assessing usability of an online-program
Time Frame
3 minutes
Title
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
Description
10-item questionnaire assessing general self-efficacy
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hansjörg Znoj, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Berger, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universität Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33331830
Citation
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.
Results Reference
derived

Learn more about this trial

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

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