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Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression (HERMES)

U

University of Bern

Status

Completed

Conditions

Depression Mild
Depression Moderate

Treatments

Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)

Study type

Interventional

Funder types

Other

Identifiers

NCT04318236
KEK BE 2019-01795

Details and patient eligibility

About

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.

Enrollment

316 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

316 participants in 16 patient groups

Online-Program + factors 1,2,3,4
Experimental group
Description:
In this "arm" all four factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,2,3
Experimental group
Description:
In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,2,4
Experimental group
Description:
In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,2
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * motivational module
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,3,4
Experimental group
Description:
In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * guidance * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,3
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * guidance
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 1,4
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factor 1
Experimental group
Description:
In this "arm" one factor is set to "active" (i.e. yes): - diagnostic interview
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 2,3,4
Experimental group
Description:
In this "arm" three factors are set to "active" (i.e. yes): * motivational module * guidance * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 2,3
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * motivational module * guidance
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 2,4
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * motivational module * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factor 2
Experimental group
Description:
In this "arm" one factor is set to "active" (i.e. yes): - motivational module
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factors 3,4
Experimental group
Description:
In this "arm" two factors are set to "active" (i.e. yes): * guidance * e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factor 3
Experimental group
Description:
In this "arm" one factor is set to "active" (i.e. yes): - guidance
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + factor 4
Experimental group
Description:
In this "arm" one factor is set to "active" (i.e. yes): - e-mail reminders
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
Online-Program + no factor
Experimental group
Description:
In this "arm" no factor is set to "active" (i.e. yes):
Treatment:
Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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