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Completed

NCT Number: NCT03379155

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.

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Key information

Conditions

Adjustment Disorders Mental Disorders Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern, Bern, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based self-help program

Other

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 outcomes

  1. Adjustment Disorder - New Module 20 (ADNM-20)

    Time frame: 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 outcomes

  1. Brief Symptom Inventory - Short Version (BSI-18)

    Time frame: 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).

  2. Beck Depression Inventory (BDI)

    Time frame: 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).

  3. Short Form 12-Item Survey (SF-12)

    Time frame: 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.

  4. Sense of Coherence Questionaire Revised (SOC-R)

    Time frame: 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).

  5. Questionnaire for measuring patient satisfaction (ZUF-8)

    Time frame: 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).

  6. Credibility/Expectancy Questionaire (CEQ)

    Time frame: 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%).

  7. System Usability Scale (SUS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: ZIEL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 20, 2017
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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