Internet-based Self-help for Negative Life Events

NCT03379155 | Completed

• 1 other identifier: ZIEL
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

Adjustment Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Brief Symptom Inventory - Short Version (BSI-18)

  4-week

• Beck Depression Inventory (BDI)

  4-week

• Short Form 12-Item Survey (SF-12)

  4-week

• Sense of Coherence Questionaire Revised (SOC-R)

  4-week

• Questionnaire for measuring patient satisfaction (ZUF-8)

  4-week

Study Arms (2)

Active Group

EXPERIMENTAL

Internet-based self-help

Other: Internet-based self-help program

Waiting List Group

NO INTERVENTION

Interventions

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).

Active Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Negative life event in a period between two weeks and two years before the study
• Internet account
• Sufficient German language skills
• Informed consent

You may not qualify if:

• Persons with moderate or severe depressive symptoms
• Acute suicidality
• Psychotic disorder, bipolar disorder
• Severe, acute mental or physical disorder

Sponsors & Collaborators

• University of Bern: lead
• University of Zurich: collaborator

Study Sites (2)

University of Bern

Bern, 3012, Switzerland

Location

Universität Zürich

Zurich, 8050, Switzerland

Location

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Andreas Maercker, Prof.

  Universität Zürich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial design, comparing to a waitling list

Study Record Dates

• First Submitted: December 14, 2017
• First Posted: December 20, 2017
• Study Start: January 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (2)