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

NCT ID: NCT04318236

Last Updated: 2021-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-03

Study Completion Date

2021-02-01

Brief Summary

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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

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Conditions

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Depression Mild Depression Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants only know that the delivery or the context of online interventions are to be improved and investigated. However, they don't know the exact interventions.

Study Groups

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Online-Program + factors 1,2,3,4

In this "arm" all four factors are set to "active" (i.e. yes):

* diagnostic interview
* motivational module
* guidance
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,2,3

In this "arm" three factors are set to "active" (i.e. yes):

* diagnostic interview
* motivational module
* guidance

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,2,4

In this "arm" three factors are set to "active" (i.e. yes):

* diagnostic interview
* motivational module
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,2

In this "arm" two factors are set to "active" (i.e. yes):

* diagnostic interview
* motivational module

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,3,4

In this "arm" three factors are set to "active" (i.e. yes):

* diagnostic interview
* guidance
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,3

In this "arm" two factors are set to "active" (i.e. yes):

* diagnostic interview
* guidance

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 1,4

In this "arm" two factors are set to "active" (i.e. yes):

* diagnostic interview
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factor 1

In this "arm" one factor is set to "active" (i.e. yes):

\- diagnostic interview

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 2,3,4

In this "arm" three factors are set to "active" (i.e. yes):

* motivational module
* guidance
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 2,3

In this "arm" two factors are set to "active" (i.e. yes):

* motivational module
* guidance

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 2,4

In this "arm" two factors are set to "active" (i.e. yes):

* motivational module
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factor 2

In this "arm" one factor is set to "active" (i.e. yes):

\- motivational module

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factors 3,4

In this "arm" two factors are set to "active" (i.e. yes):

* guidance
* e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factor 3

In this "arm" one factor is set to "active" (i.e. yes):

\- guidance

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + factor 4

In this "arm" one factor is set to "active" (i.e. yes):

\- e-mail reminders

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Online-Program + no factor

In this "arm" no factor is set to "active" (i.e. yes):

Group Type EXPERIMENTAL

HERMES (Online Self-Help Intervention based on problem-solving therapy)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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diagnostic telephone interview (yes/no) (prior to the access to HERMES) motivational module (yes/no) (prior to the access to HERMES) guidance (yes/no) (during the usage of HERMES) e-mail reminders (yes/no) (during the usage of HERMES)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Berger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Bern

Locations

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University of Bern

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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Bur OT, Berger T. Participant Adherence and Contact Behavior in a Guided Internet Intervention for Depressive Symptoms: Exploratory Study. JMIR Form Res. 2024 Dec 16;8:e46860. doi: 10.2196/46860.

Reference Type DERIVED
PMID: 39679951 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35306266 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33528377 (View on PubMed)

Related Links

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Other Identifiers

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KEK BE 2019-01795

Identifier Type: -

Identifier Source: org_study_id

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