Clinical trial NCT04318236: Factorial Trial Investigating Outcome and Adherence Relevant Factors in an Online Self-help Intervention for Depression
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Depression Moderate
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 316
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Baseline
measure: Change in Depressive Symptoms
timeFrame: 2 weeks
measure: Change in Depressive Symptoms
timeFrame: 4 weeks
measure: Change in Depressive Symptoms
timeFrame: 10 weeks
measure: Change in Depressive Symptoms
timeFrame: 16 weeks
Secondary outcomes:
measure: Adherence to Intervention (1)
timeFrame: through study completion, an average of 16 weeks
measure: Adherence to Intervention (2)
timeFrame: through study completion, an average of 16 weeks
measure: Adherence to Intervention (3)
timeFrame: through study completion, an average of 16 weeks
measure: Anxiety Symptoms
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Stress Symptoms
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Health
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Suicidal Tendency
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Social Problem Solving
timeFrame: Baseline, 10 weeks, 16 weeks
measure: Satisfaction with treatment
timeFrame: 10 weeks
measure: Negative Effects of Psychotherapy
timeFrame: 10 weeks, 16 weeks
measure: Usability of Intervention
timeFrame: 10 weeks
Other outcomes:
measure: Credibility and Expectancy
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Working Alliance
timeFrame: Baseline, 2 weeks, 4 weeks
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Thomas Berger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the context of support of web-based self-help in individuals with mild to moderate depressive symptoms: A randomized full factorial trial. Behav Res Ther. 2022 May;152:104070. doi: 10.1016/j.brat.2022.104070. Epub 2022 Mar 6.
citation: Bur OT, Krieger T, Moritz S, Klein JP, Berger T. Optimizing the Context of Support to Improve Outcomes of Internet-Based Self-help in Individuals With Depressive Symptoms: Protocol for a Randomized Factorial Trial. JMIR Res Protoc. 2021 Feb 2;10(2):e21207. doi: 10.2196/21207.