CClinicalTrials.gg
CompletedNCT04318236HERMESUpdated May 3, 2021

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

An interventional study of HERMES (Online Self-Help Intervention based on problem-solving therapy) in Depression Mild and Depression Moderate, sponsored by University of Bern. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-03.

Sponsored by University of Bern · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
316
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Depression Mild
  • Depression Moderate
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In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 316 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Bern is the lead sponsor of 207 studies on the registry; 47 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
316 participants (actual)

Study arms

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

    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)

  • Experimental
    Online-Program + factors 1,2,3

    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)

  • Experimental
    Online-Program + factors 1,2,4

    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)

  • Experimental
    Online-Program + factors 1,2

    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)

  • Experimental
    Online-Program + factors 1,3,4

    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)

  • Experimental
    Online-Program + factors 1,3

    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)

  • Experimental
    Online-Program + factors 1,4

    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)

  • Experimental
    Online-Program + factor 1

    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)

  • Experimental
    Online-Program + factors 2,3,4

    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)

  • Experimental
    Online-Program + factors 2,3

    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)

  • Experimental
    Online-Program + factors 2,4

    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)

  • Experimental
    Online-Program + factor 2

    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)

  • Experimental
    Online-Program + factors 3,4

    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)

  • Experimental
    Online-Program + factor 3

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

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

  • Experimental
    Online-Program + factor 4

    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)

  • Experimental
    Online-Program + no factor

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

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

Interventions

  • BehavioralHERMES (Online Self-Help Intervention based on problem-solving therapy)

    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)

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What researchers measure

Primary outcomes

  1. Change in Depressive Symptoms

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

    Time frame: Baseline

  2. Change in Depressive Symptoms

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

    Time frame: 2 weeks

  3. Change in Depressive Symptoms

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

    Time frame: 4 weeks

  4. Change in Depressive Symptoms

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

    Time frame: 10 weeks

  5. Change in Depressive Symptoms

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

    Time frame: 16 weeks

Secondary outcomes

  1. Adherence to Intervention (1)

    Assessed with the online Program. Indicator of adherence: time spent in program

    Time frame: through study completion, an average of 16 weeks

  2. Adherence to Intervention (2)

    Assessed with the online Program. Indicator of adherence: clicks

    Time frame: through study completion, an average of 16 weeks

  3. Adherence to Intervention (3)

    Assessed with the online Program. Indicator of adherence: number of exercises completed

    Time frame: through study completion, an average of 16 weeks

  4. Anxiety Symptoms

    Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)

    Time frame: Baseline, 10 weeks, 16 weeks

  5. Stress Symptoms

    Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)

    Time frame: Baseline, 10 weeks, 16 weeks

  6. Health

    Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)

    Time frame: Baseline, 10 weeks, 16 weeks

  7. Suicidal Tendency

    Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)

    Time frame: Baseline, 10 weeks, 16 weeks

  8. Social Problem Solving

    Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)

    Time frame: Baseline, 10 weeks, 16 weeks

  9. Satisfaction with treatment

    Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson \& Zwick, 1982)

    Time frame: 10 weeks

  10. Negative Effects of Psychotherapy

    Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, \& Nestoriuc, 2014)

    Time frame: 10 weeks, 16 weeks

  11. Usability of Intervention

    Assessed with System Usability Scale (SAS; Brooke, 1996)

    Time frame: 10 weeks

Other outcomes

  1. Credibility and Expectancy

    Assessed with Credibility/Expectancy Questionnaires (CEQ; Devilly \& Borkovec, 2000)

    Time frame: Baseline, 2 weeks, 4 weeks

  2. Working Alliance

    Assessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019)

    Time frame: Baseline, 2 weeks, 4 weeks

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Study locations

1 site
  • University of Bern
    Bern, 3012, Switzerland
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References and documents

Publications

  • 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. PubMed 35306266 ↗
  • 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. PubMed 33528377 ↗

Individual participant data

Plan to share: Yes — Data will be made available, after all planned analysis have been made by the Investigators.

Supporting information: Study protocol, Sap, Icf

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04318236
Lead sponsor
University of Bern
Responsible party
Sponsor
First posted
Mar 23, 2020
Start date
Mar 3, 2020
Primary completion
Feb 1, 2021
Completion
Feb 1, 2021
Last update
May 3, 2021

Study contacts

Thomas Berger, Prof. Dr.
principal investigator · University of Bern

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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