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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04318236
Other study ID # KEK BE 2019-01795
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 3, 2020
Est. completion date February 1, 2021

Study information

Verified date April 2021
Source University of Bern
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 316
Est. completion date February 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Switzerland University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Credibility and Expectancy Assessed with Credibility/Expectancy Questionnaires (CEQ; Devilly & Borkovec, 2000) Baseline, 2 weeks, 4 weeks
Other Working Alliance Assessed with Working Alliance Inventory - for Internet Interventions (WAI-I; Gomez Penedo et al., 2019) Baseline, 2 weeks, 4 weeks
Primary Change in Depressive Symptoms Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) Baseline
Primary Change in Depressive Symptoms Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) 2 weeks
Primary Change in Depressive Symptoms Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) 4 weeks
Primary Change in Depressive Symptoms Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) 10 weeks
Primary Change in Depressive Symptoms Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) 16 weeks
Secondary Adherence to Intervention (1) Assessed with the online Program. Indicator of adherence: time spent in program through study completion, an average of 16 weeks
Secondary Adherence to Intervention (2) Assessed with the online Program. Indicator of adherence: clicks through study completion, an average of 16 weeks
Secondary Adherence to Intervention (3) Assessed with the online Program. Indicator of adherence: number of exercises completed through study completion, an average of 16 weeks
Secondary Anxiety Symptoms Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002) Baseline, 10 weeks, 16 weeks
Secondary Stress Symptoms Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002) Baseline, 10 weeks, 16 weeks
Secondary Health Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998) Baseline, 10 weeks, 16 weeks
Secondary Suicidal Tendency Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017) Baseline, 10 weeks, 16 weeks
Secondary Social Problem Solving Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999) Baseline, 10 weeks, 16 weeks
Secondary Satisfaction with treatment Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982) 10 weeks
Secondary Negative Effects of Psychotherapy Assessed with "Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014) 10 weeks, 16 weeks
Secondary Usability of Intervention Assessed with System Usability Scale (SAS; Brooke, 1996) 10 weeks
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