Skip to main content
OpenTrials
Completed

NCT Number: NCT04318236

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Depression Mild Depression Moderate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bern

Bern, 3012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Acronym: HERMES

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2020
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.