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

Depression Mild Clinical Trial

— HERMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04318236
• Other study ID #: KEK BE 2019-01795
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depressive Disorder

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

External Links

•   Homepage of the study