Internet-based Self-help for Negative Life Events

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Adjustment Disorders

Intervention / Treatment
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* Other: Internet-based self-help program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial design, comparing to a waitling list
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group<br>Internet-based self-help | Other: Internet-based self-help program<br>* 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).<br>|
| No Intervention: Waiting List Group<br> | |

What is the study measuring?
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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 |