Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression
- Conditions
- Depression MildDepression Moderate
- Interventions
- Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)
- Registration Number
- NCT04318236
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Online-Program + factors 1,2,3,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" all four factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance * e-mail reminders Online-Program + factor 1 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" one factor is set to "active" (i.e. yes): - diagnostic interview Online-Program + factors 1,2,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * e-mail reminders Online-Program + factors 1,3,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * guidance * e-mail reminders Online-Program + factors 1,3 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * guidance Online-Program + factors 2,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * motivational module * e-mail reminders Online-Program + factor 4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" one factor is set to "active" (i.e. yes): - e-mail reminders Online-Program + factors 1,2,3 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" three factors are set to "active" (i.e. yes): * diagnostic interview * motivational module * guidance Online-Program + factors 1,2 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * motivational module Online-Program + factors 1,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * diagnostic interview * e-mail reminders Online-Program + factor 3 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" one factor is set to "active" (i.e. yes): - guidance Online-Program + factors 2,3,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" three factors are set to "active" (i.e. yes): * motivational module * guidance * e-mail reminders Online-Program + factors 2,3 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * motivational module * guidance Online-Program + factor 2 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" one factor is set to "active" (i.e. yes): - motivational module Online-Program + factors 3,4 HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" two factors are set to "active" (i.e. yes): * guidance * e-mail reminders Online-Program + no factor HERMES (Online Self-Help Intervention based on problem-solving therapy) In this "arm" no factor is set to "active" (i.e. yes):
- Primary Outcome Measures
Name Time Method Change in Depressive Symptoms 16 weeks Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
- Secondary Outcome Measures
Name Time Method Adherence to Intervention (1) through study completion, an average of 16 weeks Assessed with the online Program. Indicator of adherence: time spent in program
Adherence to Intervention (2) through study completion, an average of 16 weeks Assessed with the online Program. Indicator of adherence: clicks
Health Baseline, 10 weeks, 16 weeks Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)
Adherence to Intervention (3) through study completion, an average of 16 weeks Assessed with the online Program. Indicator of adherence: number of exercises completed
Anxiety Symptoms Baseline, 10 weeks, 16 weeks Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)
Stress Symptoms Baseline, 10 weeks, 16 weeks Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)
Satisfaction with treatment 10 weeks Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson \& Zwick, 1982)
Suicidal Tendency Baseline, 10 weeks, 16 weeks Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)
Social Problem Solving Baseline, 10 weeks, 16 weeks Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)
Usability of Intervention 10 weeks Assessed with System Usability Scale (SAS; Brooke, 1996)
Negative Effects of Psychotherapy 10 weeks, 16 weeks Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, \& Nestoriuc, 2014)
Trial Locations
- Locations (1)
University of Bern
🇨🇭Bern, Switzerland