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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318236
Recruitment Status : Recruiting
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Bern

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.

Condition or disease Intervention/treatment Phase
Depression Mild Depression Moderate Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Masking: Single (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.
Primary Purpose: Treatment
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
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)

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)

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.

Other Names:
  • 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)




Primary Outcome Measures :
  1. Change in Depressive Symptoms [ Time Frame: Baseline ]
    Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)

  2. Change in Depressive Symptoms [ Time Frame: 2 weeks ]
    Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)

  3. Change in Depressive Symptoms [ Time Frame: 4 weeks ]
    Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)

  4. Change in Depressive Symptoms [ Time Frame: 10 weeks ]
    Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)

  5. Change in Depressive Symptoms [ Time Frame: 16 weeks ]
    Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)


Secondary Outcome Measures :
  1. Adherence to Intervention (1) [ Time Frame: through study completion, an average of 16 weeks ]
    Assessed with the online Program. Indicator of adherence: time spent in program

  2. Adherence to Intervention (2) [ Time Frame: through study completion, an average of 16 weeks ]
    Assessed with the online Program. Indicator of adherence: clicks

  3. Adherence to Intervention (3) [ Time Frame: through study completion, an average of 16 weeks ]
    Assessed with the online Program. Indicator of adherence: number of exercises completed

  4. Anxiety Symptoms [ Time Frame: Baseline, 10 weeks, 16 weeks ]
    Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)

  5. Stress Symptoms [ Time Frame: Baseline, 10 weeks, 16 weeks ]
    Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)

  6. Health [ Time Frame: Baseline, 10 weeks, 16 weeks ]
    Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)

  7. Suicidal Tendency [ Time Frame: Baseline, 10 weeks, 16 weeks ]
    Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)

  8. Social Problem Solving [ Time Frame: Baseline, 10 weeks, 16 weeks ]
    Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)

  9. Satisfaction with treatment [ Time Frame: 10 weeks ]
    Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982)

  10. Negative Effects of Psychotherapy [ Time Frame: 10 weeks, 16 weeks ]
    Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014)

  11. Usability of Intervention [ Time Frame: 10 weeks ]
    Assessed with System Usability Scale (SAS; Brooke, 1996)


Other Outcome Measures:
  1. Credibility and Expectancy [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Assessed with Credibility/Expectancy Questionnaires (CEQ; Devilly & Borkovec, 2000)

  2. Working Alliance [ Time Frame: Baseline, 2 weeks, 4 weeks ]
    Assessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318236


Contacts
Layout table for location contacts
Contact: Thomas Berger, Prof. Dr. +41 31 631 34 07 thomas.berger@psy.unibe.ch
Contact: Oliver T Bur, M Sc +41 31 631 54 13 oliver.bur@psy.unibe.ch

Locations
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Switzerland
University of Bern Recruiting
Bern, Switzerland, 3012
Contact: Thomas Berger, Prof. Dr.    +41 31 631 34 07    thomas.berger@psy.unibe.ch   
Principal Investigator: Thomas Berger, Prof. Dr.         
Sponsors and Collaborators
University of Bern
Investigators
Layout table for investigator information
Principal Investigator: Thomas Berger, Prof. Dr. University of Bern
Additional Information:
Layout table for additonal information
Responsible Party: University of Bern
ClinicalTrials.gov Identifier: NCT04318236    
Other Study ID Numbers: KEK BE 2019-01795
First Posted: March 23, 2020    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be made available, after all planned analysis have been made by the Investigators.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data: Begin 2022 Other information: when available
Access Criteria: will be decided individually

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders