Internet-based Self-help for Negative Life Events

Adjustment Disorders Clinical Trial

— ZIEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03379155
• Other study ID #: ZIEL
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: October 2019
• Source: University of Bern
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: March 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adjustment Disorders

Intervention

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).

Locations

Country	Name	City	State
Switzerland	University of Bern	Bern
Switzerland	Universität Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Bern	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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