NCT04318236

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

March 17, 2020

Last Update Submit

April 30, 2021

Conditions

Depression MildDepression Moderate

Outcome Measures

Primary Outcomes (5)

  • Change in Depressive Symptoms

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

    Baseline

  • Change in Depressive Symptoms

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

    2 weeks

  • Change in Depressive Symptoms

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

    4 weeks

  • Change in Depressive Symptoms

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

    10 weeks

  • Change in Depressive Symptoms

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

    16 weeks

Secondary Outcomes (11)

  • Adherence to Intervention (1)

    through study completion, an average of 16 weeks

  • Adherence to Intervention (2)

    through study completion, an average of 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

  • +6 more secondary outcomes

Other Outcomes (2)

  • Credibility and Expectancy

    Baseline, 2 weeks, 4 weeks

  • Working Alliance

    Baseline, 2 weeks, 4 weeks

Study Arms (16)

Online-Program + factors 1,2,3,4

EXPERIMENTAL

In this "arm" all four factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance * e-mail reminders

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

Online-Program + factors 1,2,3

EXPERIMENTAL

In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance

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

Online-Program + factors 1,2,4

EXPERIMENTAL

In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * e-mail reminders

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

Online-Program + factors 1,2

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * motivational module

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

Online-Program + factors 1,3,4

EXPERIMENTAL

In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * guidance * e-mail reminders

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

Online-Program + factors 1,3

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * guidance

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

Online-Program + factors 1,4

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * e-mail reminders

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

Online-Program + factor 1

EXPERIMENTAL

In this "arm" one factor is set to "active" (i.e. yes): \- diagnostic interview

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

Online-Program + factors 2,3,4

EXPERIMENTAL

In this "arm" three factors are set to "active" (i.e. yes): * motivational module * guidance * e-mail reminders

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

Online-Program + factors 2,3

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * motivational module * guidance

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

Online-Program + factors 2,4

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * motivational module * e-mail reminders

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

Online-Program + factor 2

EXPERIMENTAL

In this "arm" one factor is set to "active" (i.e. yes): \- motivational module

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

Online-Program + factors 3,4

EXPERIMENTAL

In this "arm" two factors are set to "active" (i.e. yes): * guidance * e-mail reminders

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

Online-Program + factor 3

EXPERIMENTAL

In this "arm" one factor is set to "active" (i.e. yes): \- guidance

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

Online-Program + factor 4

EXPERIMENTAL

In this "arm" one factor is set to "active" (i.e. yes): \- e-mail reminders

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

Online-Program + no factor

EXPERIMENTAL

In this "arm" no factor is set to "active" (i.e. yes):

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

Interventions

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

The Online Self-Help Intervention is an online program based on the problem-solving therapy (an evidence based approach of psychotherapy). All participants will receive the exact same intervention. However, what will be experimentally varied are the four listed interventions.

Also known as: diagnostic telephone interview (yes/no) (prior to the access to HERMES), motivational module (yes/no) (prior to the access to HERMES), guidance (yes/no) (during the usage of HERMES), e-mail reminders (yes/no) (during the usage of HERMES)
Online-Program + factor 1Online-Program + factor 2Online-Program + factor 3Online-Program + factor 4Online-Program + factors 1,2Online-Program + factors 1,2,3Online-Program + factors 1,2,3,4Online-Program + factors 1,2,4Online-Program + factors 1,3Online-Program + factors 1,3,4Online-Program + factors 1,4Online-Program + factors 2,3Online-Program + factors 2,3,4Online-Program + factors 2,4Online-Program + factors 3,4Online-Program + no factor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern

Bern, 3012, Switzerland

Location

Related Publications (3)

  • Bur OT, Berger T. Participant Adherence and Contact Behavior in a Guided Internet Intervention for Depressive Symptoms: Exploratory Study. JMIR Form Res. 2024 Dec 16;8:e46860. doi: 10.2196/46860.

    PMID: 39679951DERIVED

  • Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: A randomized full factorial trial. Behav Res Ther. 2022 May;152:104070. doi: 10.1016/j.brat.2022.104070. Epub 2022 Mar 6.

    PMID: 35306266DERIVED

  • Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e21207. doi: 10.2196/21207.

    PMID: 33528377DERIVED

Related Links

MeSH Terms

Interventions

RBPMS protein, humanCounseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Thomas Berger, Prof. Dr.

    University of Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants only know that the delivery or the context of online interventions are to be improved and investigated. However, they don't know the exact interventions.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2020

First Posted

March 23, 2020

Study Start

March 3, 2020

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Data will be made available, after all planned analysis have been made by the Investigators.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data: Begin 2022 Other information: when available
Access Criteria
will be decided individually

Locations

CH(1)