Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression (HERMES)
Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bern, Switzerland, 3012
- University of Bern
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Online-Program + factors 1,2,3,4
In this "arm" all four factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,2,3
In this "arm" three factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,2,4
In this "arm" three factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,2
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,3,4
In this "arm" three factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,3
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 1,4
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factor 1
In this "arm" one factor is set to "active" (i.e. yes): - diagnostic interview |
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:
|
|
EXPERIMENTAL: Online-Program + factors 2,3,4
In this "arm" three factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 2,3
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factors 2,4
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factor 2
In this "arm" one factor is set to "active" (i.e. yes): - motivational module |
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:
|
|
EXPERIMENTAL: Online-Program + factors 3,4
In this "arm" two factors are set to "active" (i.e. yes):
|
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:
|
|
EXPERIMENTAL: Online-Program + factor 3
In this "arm" one factor is set to "active" (i.e. yes): - guidance |
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:
|
|
EXPERIMENTAL: Online-Program + factor 4
In this "arm" one factor is set to "active" (i.e. yes): - e-mail reminders |
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:
|
|
EXPERIMENTAL: Online-Program + no factor
In this "arm" no factor is set to "active" (i.e.
yes):
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Depressive Symptoms
Time Frame: Baseline
|
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
Baseline
|
|
Change in Depressive Symptoms
Time Frame: 2 weeks
|
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
2 weeks
|
|
Change in Depressive Symptoms
Time Frame: 4 weeks
|
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
4 weeks
|
|
Change in Depressive Symptoms
Time Frame: 10 weeks
|
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
10 weeks
|
|
Change in Depressive Symptoms
Time Frame: 16 weeks
|
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001)
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
through study completion, an average of 16 weeks
|
|
Adherence to Intervention (2)
Time Frame: through study completion, an average of 16 weeks
|
Assessed with the online Program.
Indicator of adherence: clicks
|
through study completion, an average of 16 weeks
|
|
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
|
through study completion, an average of 16 weeks
|
|
Anxiety Symptoms
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
|
Baseline, 10 weeks, 16 weeks
|
|
Stress Symptoms
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
|
Baseline, 10 weeks, 16 weeks
|
|
Health
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
|
Baseline, 10 weeks, 16 weeks
|
|
Suicidal Tendency
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
|
Baseline, 10 weeks, 16 weeks
|
|
Social Problem Solving
Time Frame: Baseline, 10 weeks, 16 weeks
|
Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
|
Baseline, 10 weeks, 16 weeks
|
|
Satisfaction with treatment
Time Frame: 10 weeks
|
Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982)
|
10 weeks
|
|
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)
|
10 weeks, 16 weeks
|
|
Usability of Intervention
Time Frame: 10 weeks
|
Assessed with System Usability Scale (SAS; Brooke, 1996)
|
10 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Credibility and Expectancy
Time Frame: Baseline, 2 weeks, 4 weeks
|
Assessed with Credibility/Expectancy Questionnaires (CEQ; Devilly & Borkovec, 2000)
|
Baseline, 2 weeks, 4 weeks
|
|
Working Alliance
Time Frame: Baseline, 2 weeks, 4 weeks
|
Assessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019)
|
Baseline, 2 weeks, 4 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK BE 2019-01795
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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