Internet-based Self-help for Negative Life Events

Not Applicable

Completed

• Conditions: Adjustment Disorders
• Interventions: Other: Internet-based self-help program

• Registration Number: NCT03379155
• Lead Sponsor: University of Bern

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.

Study Timeline

• Study First Submitted: 2017-12-14
• Study First Submitted QC: 2017-12-14
• Study First Posted: 2017-12-20
• Study Start: 2018-01-01
• Primary Completion: 2019-02-01
• Study Completion: 2019-03-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-10
• Last Update Posted: 2019-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Group	Internet-based self-help program	Internet-based self-help

Primary Outcome Measures

Name	Time	Method
Adjustment Disorder - New Module 20 (ADNM-20)	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 Outcome Measures

Name	Time	Method
Credibility/Expectancy Questionaire (CEQ)	4-week	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%).
Beck Depression Inventory (BDI)	4-week	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).
Questionnaire for measuring patient satisfaction (ZUF-8)	4-week	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).
Short Form 12-Item Survey (SF-12)	4-week	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)	4-week	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).
Brief Symptom Inventory - Short Version (BSI-18)	4-week	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).
System Usability Scale (SUS)	4-week	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).

Trial Locations

Locations (2)

Universität Zürich; 🇨🇭 Zürich, Switzerland

University of Bern; 🇨🇭 Bern, Switzerland