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

NCT ID: NCT03785912

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2021-11-28

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.

Detailed Description

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Conditions

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Adjustment Impairment Accident Adjustment Disorders Mental Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Internet-based self-help

Intervention Type BEHAVIORAL

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

Waiting control group

Access to internet-based intervention after 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet-based self-help

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Accident Insurance Fund SUVA

UNKNOWN

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hansjörg Znoj, Prof. Dr.

Role: STUDY_DIRECTOR

University of Bern

Thomas Berger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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Universität Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 33331830 (View on PubMed)

Other Identifiers

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2018-01059

Identifier Type: -

Identifier Source: org_study_id