Skip to main content
Clinical Trials/NCT04318236
NCT04318236
Completed
Not Applicable

Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms

University of Bern1 site in 1 country316 target enrollmentMarch 3, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression Mild
Sponsor
University of Bern
Enrollment
316
Locations
1
Primary Endpoint
Change in Depressive Symptoms
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

A vast amount of studies show that online interventions are suitable to reduce symptoms of mental illness as for instance depression or anxiety. However, participants who use online interventions are more likely to drop out of treatment compared to face-to-face interventions. It is important to enhance adherence to online interventions so that participants engage longer in the programs. Also, as online interventions are useful to reduce the burden of mental illness, it is of interest to further improve outcomes of such interventions. Therefore, it will be investigated in this study whether or not four different factors have an impact in fostering adherence to and improving outcome of an internet-based self-help intervention based on problem-solving therapy. A multifactorial design will be used for this study to screen simultaneously whether or not i) a diagnostic telephone interview and, ii) an educational module based on motivational interviewing prior to the intervention and iii) guidance by the study team, and iv) automated e-mail reminders during the study are active factors in enhancing adherence to and outcome of online interventions.

Registry
clinicaltrials.gov
Start Date
March 3, 2020
End Date
February 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • PHQ-9-Score between 5 - 14
  • Signed Informed Consent
  • Contact information provided in case of emergency
  • Internet connection and device to use it (Smartphone, Computer, Tablet)
  • Fluent in german language

Exclusion Criteria

  • Suicidal tendencies (SBQ-R \> 7)
  • a current or previous diagnose of a bipolar or psychotic disorder
  • a current diagnosis of severe depression or another psychological disorder

Outcomes

Primary Outcomes

Change in Depressive Symptoms

Time Frame: 16 weeks

Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)

Secondary Outcomes

  • Adherence to Intervention (1)(through study completion, an average of 16 weeks)
  • Adherence to Intervention (2)(through study completion, an average of 16 weeks)
  • Health(Baseline, 10 weeks, 16 weeks)
  • Adherence to Intervention (3)(through study completion, an average of 16 weeks)
  • Anxiety Symptoms(Baseline, 10 weeks, 16 weeks)
  • Stress Symptoms(Baseline, 10 weeks, 16 weeks)
  • Satisfaction with treatment(10 weeks)
  • Suicidal Tendency(Baseline, 10 weeks, 16 weeks)
  • Social Problem Solving(Baseline, 10 weeks, 16 weeks)
  • Usability of Intervention(10 weeks)
  • Negative Effects of Psychotherapy(10 weeks, 16 weeks)

Study Sites (1)

Loading locations...

Similar Trials