Adjustment ImpairmentSelFITNCT03785912
SelFIT: Internet-based Treatment for Adjustment Problems After an Accident
A study testing Internet-based self-help in people with Adjustment Impairment and Accident, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjustment Impairment, Accident, Adjustment Disorders
- What is being tested?
- Internet-based self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Dec 2019to 28 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Adjustment Impairment, Accident, Adjustment Disorders, Mental Disorder
- Being tested
- Internet-based self-help
- Medical subject headings
- Adjustment Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-helpBehavioural
Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based self-help | Experimental | 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. Receives: Behavioral: Internet-based self-help |
| Waiting control group | No intervention | Access to internet-based intervention after 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
21-item questionnaire assessing depression, anxiety and stress symptoms
Measured: 7 minutes
Secondary outcomes (10)
BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)
21-item questionnaire assessing depressive symptoms
Measured: 5-10 minutes
ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)
20-item questionnaire assessing adjustment disorder symptoms and severity
Measured: 6 minutes
SF-12: Short Form Health Survey (Ware et al., 1996)
12-item questionnaire assessing various aspects of well-being
Measured: 5 minutes
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
10-item questionnaire assessing optimism and pessimism
Measured: 3 minutes
BVI: Berner Verbitterungsinventar (Znoj, 2008)
18-item questionnaire assessing embitterment
Measured: 3 minutes
FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)
24-item questionnaire assessing different aspects of work- and health-related topics
Measured: 5 minutes
TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)
58-item questionnaire assessing costs related to an accident
Measured: 20 minutes
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
8-item questionnaire assessing content with an online-program
Measured: 2 minutes
SUS: System Usability Scale (Brooke, 1996)
10-item questionnaire assessing usability of an online-program
Measured: 3 minutes
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
10-item questionnaire assessing general self-efficacy
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start18 Dec 2019
- Primary completion28 Nov 2021
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjustment ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Accident Insurance Fund SUVA
- Responsible party
- Sponsor
- Investigators
- Hansjörg Znoj, Prof. Dr., Study director, University of BernThomas Berger, Prof. Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785912
- Sponsor's protocol ID
- 2018-01059
- Other IDs
- 2018
- Acronym
- SelFIT
- Status last verified
- Dec 2021
- First submitted
- 20 Dec 2018
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03785912
- Acronym / sponsor ID
- SelFIT / 2018-01059
- Conditions
- Adjustment Impairment, Accident, Adjustment Disorders, Mental Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- Swiss Accident Insurance Fund SUVA
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 28 Nov 2021 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based self-help | Experimental | Behavioral: Internet-based self-helpThe 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. |
| Waiting control group | No intervention | –Access to internet-based intervention after 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based self-helpEight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident. | Behavioural | Internet-based self-help |
Primary outcome
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995)
Time frame: 7 minutes
21-item questionnaire assessing depression, anxiety and stress symptoms
10 secondary outcomes
BDI-II:Beck Depression Inventory (Beck et al., 1996; Margraf & Ehlers, 1998)
Time frame: 5-10 minutes
ADNM-20: Adjustment Disorder - New Module 20 (Lorenz et al., 2016)
Time frame: 6 minutes
SF-12: Short Form Health Survey (Ware et al., 1996)
Time frame: 5 minutes
LOT-R: Revised Life Orientation Test (Herzberg et al., 2006)
Time frame: 3 minutes
BVI: Berner Verbitterungsinventar (Znoj, 2008)
Time frame: 3 minutes
FAB: Fragebogen Arbeit und Wohlbefinden (Abegglen et al., 2017)
Time frame: 5 minutes
TIC-P: Treatment inventory of Costs in Psychiatric Patients (Bouwmans et al., 2013)
Time frame: 20 minutes
ZUF-8: Zufriedenheitsfragebogen (Attkisson & Zwick, 1982)
Time frame: 2 minutes
SUS: System Usability Scale (Brooke, 1996)
Time frame: 3 minutes
SWE: Skala zur Allgemeinen Selbstwirksamkeit (Jerusalem & Schwarzer, 2003)
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 33331830Hegy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hansjörg Znoj, Prof. Dr. study director
University of Bern
Thomas Berger, Prof. Dr. principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based self-help in people with Adjustment Impairment and Accident, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DASS-21: Depression, Angst, Stress-Skala (Lovibond & Lovibond, 1995) (time frame: 7 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03785912, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.