Adjustment DisordersZIELNCT03379155
Internet-based Self-help for Negative Life Events
A study testing Internet-based self-help program in people with Adjustment Disorders, run by University of Bern at 2 sites in Switzerland.
Trial summary
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adjustment Disorders
- What is being tested?
- Internet-based self-help program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jan 2018to 1 Mar 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Negative life event in a period between two weeks and two years before the study
- Internet account
- Sufficient German language skills
- Informed consent
Who cannot join
- Persons with moderate or severe depressive symptoms
- Acute suicidality
- Psychotic disorder, bipolar disorder
- Severe, acute mental or physical disorder
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University of Bern
Bern, 3012
Universität Zürich
Zurich, 8050
About this study
Official title: ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events.
Read the detailed description
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events compared to a waiting list, in a randomized controlled trial design. Assessments are at baseline, 4-week and 3 months post-randomization. After 4 weeks, participants in the waiting control group get also access to the intervention.
- Conditions
- Adjustment Disorders
- Being tested
- Internet-based self-help program
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based self-help programOther
The intervention provided is based on the principles of cognitive behavioral therapy (CBT) (Bachem \& Maercker, 2013). The manual integrates a variety of approaches validated as treatments for PTSD, anxiety disorders, or depression; the selection focuses on exercises which are intended to target the main symptoms of AjD, namely preoccupations (e.g. constant rumination, excessive worry about the stressor) and failure to adapt (e.g. sleep disturbance, difficulties concentrating, loss of interest in previously enjoyable activities).
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Experimental | Internet-based self-help Receives: Other: Internet-based self-help program |
| Waiting List Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjustment Disorder - New Module 20 (ADNM-20)
The ADNM-20 is a self-report assessment for adjustment disorder. It is aimed at adults who feel burdened by a critical life event.
The ADNM-20 consists of two parts: an event list for recording stress and an item list for recording the resulting symptoms. In the event list, all burdens during the last two years are recorded and the subjectively highest burdens are named. On the basis of the item list, preoccupations and mismatch, the main symptom groups of the adaptation disorder according to ICD-11, as well as the concomitant symptoms of avoidance, depressiveness, anxiety, impulse control problems and functional impairment are recorded.
The scale ranges from 0 (no stress) to 80 (high exposure).
Measured: 4-week
Secondary outcomes (7)
Brief Symptom Inventory - Short Version (BSI-18)
The short version of the Brief Symptom Inventory (BSI-18) is an easily applicable, reliable and valid self-report measure in wide international use. It assesses the syndromes of somatisation, depression and anxiety by means of 6 items each.
The global factor ranges from 0 (no symptoms) to 72 (high symptomatic burden).
Measured: 4-week
Beck Depression Inventory (BDI)
The BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.
The score ranges from 0 (no symptoms) to 63 (severe depression).
Measured: 4-week
Short Form 12-Item Survey (SF-12)
The SF-12 consists of 12 questions and is a general health questionnaire that provides information on the patient's state of health in more than 8 different dimensions.
Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Measured: 4-week
Sense of Coherence Questionaire Revised (SOC-R)
The SOC-R is a new conceptualization and operationalization of the resilience indicator SOC.
The total score ranges from 13 (low) to 65 (high SOC).
Measured: 4-week
Questionnaire for measuring patient satisfaction (ZUF-8)
The ZUF-8 is a self-assessment tool to assess the patient's satisfaction with regard to aspects of the clinic and treatment.
The scale ranges from 8 (bad) to 32 (good satisfaction).
Measured: 4-week
Credibility/Expectancy Questionaire (CEQ)
The CEQ is a scale for measuring treatment expectancy and rationale credibility for use in clinical outcome studies.
The CEQ utilizes two scales during the administration (1-9, and 0-100%).
Measured: 4-week
System Usability Scale (SUS)
The System Usability Scale (SUS) is a simple and technology-independent questionnaire to evaluate the usability of a system.
The score ranges from 0 (worst) to 100 (best).
Measured: 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Jan 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adjustment DisordersStudies 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
- Model description
- Randomized controlled trial design, comparing to a waitling list
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Andreas Maercker, Prof., Study chair, Universität Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379155
- Sponsor's protocol ID
- ZIEL
- Acronym
- ZIEL
- Status last verified
- Oct 2019
- First submitted
- 14 Dec 2017
- Last updated
- 14 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events
- ClinicalTrials.gov ID
- NCT03379155
- Acronym / sponsor ID
- ZIEL / ZIEL
- Conditions
- Adjustment Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Dec 2017 (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.
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events.
Detailed description
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful life events compared to a waiting list, in a randomized controlled trial design. Assessments are at baseline, 4-week and 3 months post-randomization. After 4 weeks, participants in the waiting control group get also access to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial design, comparing to a waitling list
| Arm | Type | Receives |
|---|---|---|
| Active Group | Experimental | Other: Internet-based self-help programInternet-based self-help |
| Waiting List Group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Negative life event in a period between two weeks and two years before the study
- Internet account
- Sufficient German language skills
- Informed consent
Key exclusion criteria (4 listed)
- Persons with moderate or severe depressive symptoms
- Acute suicidality
- Psychotic disorder, bipolar disorder
- Severe, acute mental or physical 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-help programThe intervention provided is based on the principles of cognitive behavioral therapy (CBT) (Bachem \& Maercker, 2013). The manual integrates a variety of approaches validated as treatments for PTSD, anxiety disorders, or depression; the selection focuses on exercises which are intended to target the main symptoms of AjD, namely preoccupations (e.g. constant rumination, excessive worry about the stressor) and failure to adapt (e.g. sleep disturbance, difficulties concentrating, loss of interest in previously enjoyable activities). | Other | Active Group |
Primary outcome
Adjustment Disorder - New Module 20 (ADNM-20)
Time frame: 4-week
The ADNM-20 is a self-report assessment for adjustment disorder. It is aimed at adults who feel burdened by a critical life event. The ADNM-20 consists of two parts: an event list for recording stress and an item list for recording the resulting symptoms. In the event list, all burdens during the last two years are recorded and the subjectively highest burdens are named. On the basis of the item list, preoccupations and mismatch, the main symptom groups of the adaptation disorder according to ICD-11, as well as the concomitant symptoms of avoidance, depressiveness, anxiety, impulse control problems and functional impairment are recorded. The scale ranges from 0 (no stress) to 80 (high exposure).
7 secondary outcomes
Brief Symptom Inventory - Short Version (BSI-18)
Time frame: 4-week
Beck Depression Inventory (BDI)
Time frame: 4-week
Short Form 12-Item Survey (SF-12)
Time frame: 4-week
Sense of Coherence Questionaire Revised (SOC-R)
Time frame: 4-week
Questionnaire for measuring patient satisfaction (ZUF-8)
Time frame: 4-week
Credibility/Expectancy Questionaire (CEQ)
Time frame: 4-week
System Usability Scale (SUS)
Time frame: 4-week
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 Oct 2019.
- 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.
Andreas Maercker, Prof. study chair
Universität Zürich
2 sites 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 program in people with Adjustment Disorders, run by University of Bern at 2 sites 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 4 inclusion and 4 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Adjustment Disorder - New Module 20 (ADNM-20) (time frame: 4-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2019.