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Internet-based Self-help for Negative Life Events (ZIEL)

Primary Purpose

Adjustment Disorders

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Internet-based self-help program
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Bern
  • Universität Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Group

Waiting List Group

Arm Description

Internet-based self-help

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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.
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).
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).
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%).
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).

Full Information

First Posted
December 14, 2017
Last Updated
October 10, 2019
Sponsor
University of Bern
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03379155
Brief Title
Internet-based Self-help for Negative Life Events
Acronym
ZIEL
Official Title
ZIEL - Zurück Ins Eigene Leben - Internet-based Self-help for Negative Life Events
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern
Collaborators
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adjustment Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial design, comparing to a waitling list
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Group
Arm Type
Experimental
Arm Description
Internet-based self-help
Arm Title
Waiting List Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Internet-based self-help program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adjustment Disorder - New Module 20 (ADNM-20)
Description
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
Secondary Outcome Measure Information:
Title
Brief Symptom Inventory - Short Version (BSI-18)
Description
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
Title
Beck Depression Inventory (BDI)
Description
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
Title
Short Form 12-Item Survey (SF-12)
Description
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
Title
Sense of Coherence Questionaire Revised (SOC-R)
Description
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
Title
Questionnaire for measuring patient satisfaction (ZUF-8)
Description
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
Title
Credibility/Expectancy Questionaire (CEQ)
Description
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
Title
System Usability Scale (SUS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Maercker, Prof.
Organizational Affiliation
Universität Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Universität Zürich
City
Zürich
ZIP/Postal Code
8050
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet-based Self-help for Negative Life Events

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