An interventional study of Internet-based self-help program in Adjustment Disorders, sponsored by University of Bern. Completed at 2 sites in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by University of Bern · Not applicable, Interventional, and Treatment
The purpose of the study is to investigate the efficacy of an internet-based self-help intervention for dealing with stressful 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 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.
63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.
This study's enrollment of 98 is close to the median of 100 across 52 interventional studies indexed under Adjustment Disorders.
Browse Adjustment Disorders studies →University of Bern is the lead sponsor of 209 studies on the registry; 47 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Internet-based self-help
Other: Internet-based self-help program
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).
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).
Time frame: 4-week
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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%).
Time frame: 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).
Time frame: 4-week
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.