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

Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04318236
Acronym
HERMES
Enrollment
316
Registered
2020-03-23
Start date
2020-03-03
Completion date
2021-02-01
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mild, Depression Moderate

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.

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.

Sponsors

University of Bern
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

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.

Intervention model description

Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
HealthBaseline, 10 weeks, 16 weeksAssessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
Social Problem SolvingBaseline, 10 weeks, 16 weeksAssessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
Adherence to Intervention (1)through study completion, an average of 16 weeksAssessed with the online Program. Indicator of adherence: time spent in program
Adherence to Intervention (2)through study completion, an average of 16 weeksAssessed with the online Program. Indicator of adherence: clicks
Adherence to Intervention (3)through study completion, an average of 16 weeksAssessed with the online Program. Indicator of adherence: number of exercises completed
Anxiety SymptomsBaseline, 10 weeks, 16 weeksAssessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
Negative Effects of Psychotherapy10 weeks, 16 weeksAssessed with Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014)
Usability of Intervention10 weeksAssessed with System Usability Scale (SAS; Brooke, 1996)
Stress SymptomsBaseline, 10 weeks, 16 weeksAssessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
Suicidal TendencyBaseline, 10 weeks, 16 weeksAssessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
Satisfaction with treatment10 weeksAssessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982)

Other

MeasureTime frameDescription
Credibility and ExpectancyBaseline, 2 weeks, 4 weeksAssessed with Credibility/Expectancy Questionnaires (CEQ; Devilly & Borkovec, 2000)
Working AllianceBaseline, 2 weeks, 4 weeksAssessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019)

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026