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

Primary Purpose

Depression Mild, Depression Moderate

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
HERMES (Online Self-Help Intervention based on problem-solving therapy)
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression Mild

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Bern

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

Online-Program + factors 1,2,3

Online-Program + factors 1,2,4

Online-Program + factors 1,2

Online-Program + factors 1,3,4

Online-Program + factors 1,3

Online-Program + factors 1,4

Online-Program + factor 1

Online-Program + factors 2,3,4

Online-Program + factors 2,3

Online-Program + factors 2,4

Online-Program + factor 2

Online-Program + factors 3,4

Online-Program + factor 3

Online-Program + factor 4

Online-Program + no factor

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Change in Depressive Symptoms
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)

Secondary Outcome Measures

Adherence to Intervention (1)
Assessed with the online Program. Indicator of adherence: time spent in program
Adherence to Intervention (2)
Assessed with the online Program. Indicator of adherence: clicks
Adherence to Intervention (3)
Assessed with the online Program. Indicator of adherence: number of exercises completed
Anxiety Symptoms
Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
Stress Symptoms
Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
Health
Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
Suicidal Tendency
Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
Social Problem Solving
Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
Satisfaction with treatment
Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982)
Negative Effects of Psychotherapy
Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014)
Usability of Intervention
Assessed with System Usability Scale (SAS; Brooke, 1996)

Full Information

First Posted
March 17, 2020
Last Updated
April 30, 2021
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT04318236
Brief Title
Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression
Acronym
HERMES
Official Title
Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 3, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depression Moderate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online-Program + factors 1,2,3,4
Arm Type
Experimental
Arm Description
In this "arm" all four factors are set to "active" (i.e. yes): diagnostic interview motivational module guidance e-mail reminders
Arm Title
Online-Program + factors 1,2,3
Arm Type
Experimental
Arm Description
In this "arm" three factors are set to "active" (i.e. yes): diagnostic interview motivational module guidance
Arm Title
Online-Program + factors 1,2,4
Arm Type
Experimental
Arm Description
In this "arm" three factors are set to "active" (i.e. yes): diagnostic interview motivational module e-mail reminders
Arm Title
Online-Program + factors 1,2
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): diagnostic interview motivational module
Arm Title
Online-Program + factors 1,3,4
Arm Type
Experimental
Arm Description
In this "arm" three factors are set to "active" (i.e. yes): diagnostic interview guidance e-mail reminders
Arm Title
Online-Program + factors 1,3
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): diagnostic interview guidance
Arm Title
Online-Program + factors 1,4
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): diagnostic interview e-mail reminders
Arm Title
Online-Program + factor 1
Arm Type
Experimental
Arm Description
In this "arm" one factor is set to "active" (i.e. yes): - diagnostic interview
Arm Title
Online-Program + factors 2,3,4
Arm Type
Experimental
Arm Description
In this "arm" three factors are set to "active" (i.e. yes): motivational module guidance e-mail reminders
Arm Title
Online-Program + factors 2,3
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): motivational module guidance
Arm Title
Online-Program + factors 2,4
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): motivational module e-mail reminders
Arm Title
Online-Program + factor 2
Arm Type
Experimental
Arm Description
In this "arm" one factor is set to "active" (i.e. yes): - motivational module
Arm Title
Online-Program + factors 3,4
Arm Type
Experimental
Arm Description
In this "arm" two factors are set to "active" (i.e. yes): guidance e-mail reminders
Arm Title
Online-Program + factor 3
Arm Type
Experimental
Arm Description
In this "arm" one factor is set to "active" (i.e. yes): - guidance
Arm Title
Online-Program + factor 4
Arm Type
Experimental
Arm Description
In this "arm" one factor is set to "active" (i.e. yes): - e-mail reminders
Arm Title
Online-Program + no factor
Arm Type
Experimental
Arm Description
In this "arm" no factor is set to "active" (i.e. yes):
Intervention Type
Behavioral
Intervention Name(s)
HERMES (Online Self-Help Intervention based on problem-solving therapy)
Other Intervention Name(s)
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)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame
Baseline
Title
Change in Depressive Symptoms
Description
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame
2 weeks
Title
Change in Depressive Symptoms
Description
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame
4 weeks
Title
Change in Depressive Symptoms
Description
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame
10 weeks
Title
Change in Depressive Symptoms
Description
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Adherence to Intervention (1)
Description
Assessed with the online Program. Indicator of adherence: time spent in program
Time Frame
through study completion, an average of 16 weeks
Title
Adherence to Intervention (2)
Description
Assessed with the online Program. Indicator of adherence: clicks
Time Frame
through study completion, an average of 16 weeks
Title
Adherence to Intervention (3)
Description
Assessed with the online Program. Indicator of adherence: number of exercises completed
Time Frame
through study completion, an average of 16 weeks
Title
Anxiety Symptoms
Description
Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Stress Symptoms
Description
Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Health
Description
Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Suicidal Tendency
Description
Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Social Problem Solving
Description
Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
Time Frame
Baseline, 10 weeks, 16 weeks
Title
Satisfaction with treatment
Description
Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982)
Time Frame
10 weeks
Title
Negative Effects of Psychotherapy
Description
Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014)
Time Frame
10 weeks, 16 weeks
Title
Usability of Intervention
Description
Assessed with System Usability Scale (SAS; Brooke, 1996)
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Credibility and Expectancy
Description
Assessed with Credibility/Expectancy Questionnaires (CEQ; Devilly & Borkovec, 2000)
Time Frame
Baseline, 2 weeks, 4 weeks
Title
Working Alliance
Description
Assessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019)
Time Frame
Baseline, 2 weeks, 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Berger, Prof. Dr.
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern
City
Bern
ZIP/Postal Code
3012
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available, after all planned analysis have been made by the Investigators.
IPD Sharing Time Frame
Data: Begin 2022 Other information: when available
IPD Sharing Access Criteria
will be decided individually
Citations:
PubMed Identifier
35306266
Citation
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.
Results Reference
derived
PubMed Identifier
33528377
Citation
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.
Results Reference
derived
Links:
URL
https://selfhelp.psy.unibe.ch/hermes/homepage
Description
Homepage of the study

Learn more about this trial

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

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