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

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.

Study Overview

• Status: Completed
• Conditions: Adjustment Disorders
• Intervention / Treatment: Other: Internet-based self-help program

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 Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3012
    • University of Bern
  • Zürich, Switzerland, 8050
    • Universität Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Group; 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).
No Intervention: Waiting List Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	4-week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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.	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).	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).	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%).	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).	4-week

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University of Zurich
• Investigators: Study Chair: Andreas Maercker, Prof., Universität Zürich

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: December 14, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Adjustment Disorders
• Other Study ID Numbers: ZIEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No