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

Not Applicable
Completed
Conditions
Depression Mild
Depression Moderate
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
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

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Primary Outcome Measures
NameTimeMethod
Change in Depressive Symptoms16 weeks

Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)

Secondary Outcome Measures
NameTimeMethod
Adherence to Intervention (3)through study completion, an average of 16 weeks

Assessed with the online Program. Indicator of adherence: number of exercises completed

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

HealthBaseline, 10 weeks, 16 weeks

Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998)

Anxiety SymptomsBaseline, 10 weeks, 16 weeks

Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002)

Stress SymptomsBaseline, 10 weeks, 16 weeks

Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002)

Satisfaction with treatment10 weeks

Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson \& Zwick, 1982)

Suicidal TendencyBaseline, 10 weeks, 16 weeks

Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017)

Social Problem SolvingBaseline, 10 weeks, 16 weeks

Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999)

Usability of Intervention10 weeks

Assessed with System Usability Scale (SAS; Brooke, 1996)

Negative Effects of Psychotherapy10 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

University of Bern
🇨🇭Bern, Switzerland

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