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Clinical Trials/NCT03379155
NCT03379155
Completed
N/A

ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events

University of Bern2 sites in 1 country98 target enrollmentJanuary 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Adjustment Disorders
Sponsor
University of Bern
Enrollment
98
Locations
2
Primary Endpoint
Adjustment Disorder - New Module 20 (ADNM-20)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
March 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Negative life event in a period between two weeks and two years before the study
  • Internet account
  • Sufficient German language skills
  • Informed consent

Exclusion Criteria

  • Persons with moderate or severe depressive symptoms
  • Acute suicidality
  • Psychotic disorder, bipolar disorder
  • Severe, acute mental or physical disorder

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Credibility/Expectancy Questionaire (CEQ)(4-week)
  • Beck Depression Inventory (BDI)(4-week)
  • Questionnaire for measuring patient satisfaction (ZUF-8)(4-week)
  • System Usability Scale (SUS)(4-week)
  • Short Form 12-Item Survey (SF-12)(4-week)
  • Sense of Coherence Questionaire Revised (SOC-R)(4-week)
  • Brief Symptom Inventory - Short Version (BSI-18)(4-week)

Study Sites (2)

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