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

Study Overview
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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.

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

Conditions
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Depression Mild, Depression Moderate

Intervention / Treatment
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* Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Multifactorial design (factorial trial), following the Multiphase optimisation Strategy (MOST)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online-Program + factors 1,2,3,4<br>In this arm all four factors are set to active (i.e. yes): diagnostic interview motivational module guidance e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,2,3<br>In this arm three factors are set to active (i.e. yes): diagnostic interview motivational module guidance | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,2,4<br>In this arm three factors are set to active (i.e. yes): diagnostic interview motivational module e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,2<br>In this arm two factors are set to active (i.e. yes): diagnostic interview motivational module | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,3,4<br>In this arm three factors are set to active (i.e. yes): diagnostic interview guidance e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,3<br>In this arm two factors are set to active (i.e. yes): diagnostic interview guidance | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 1,4<br>In this arm two factors are set to active (i.e. yes): diagnostic interview e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factor 1<br>In this arm one factor is set to active (i.e. yes): - diagnostic interview | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 2,3,4<br>In this arm three factors are set to active (i.e. yes): motivational module guidance e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 2,3<br>In this arm two factors are set to active (i.e. yes): motivational module guidance | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 2,4<br>In this arm two factors are set to active (i.e. yes): motivational module e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factor 2<br>In this arm one factor is set to active (i.e. yes): - motivational module | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factors 3,4<br>In this arm two factors are set to active (i.e. yes): guidance e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factor 3<br>In this arm one factor is set to active (i.e. yes): - guidance | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + factor 4<br>In this arm one factor is set to active (i.e. yes): - e-mail reminders | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|
| Experimental: Online-Program + no factor<br>In this arm no factor is set to active (i.e. yes): | Behavioral: HERMES (Online Self-Help Intervention based on problem-solving therapy)<br>* 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.<br>* Other names: e-mail reminders (yes/no) (during the usage of HERMES);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms | Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) | Baseline | 
| Change in Depressive Symptoms | Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 2 weeks | 
| Change in Depressive Symptoms | Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 4 weeks | 
| Change in Depressive Symptoms | Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 10 weeks | 
| Change in Depressive Symptoms | Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer & Williams, 2001) | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Intervention (1) | Assessed with the online Program. Indicator of adherence: time spent in program | through study completion, an average of 16 weeks | 
| Adherence to Intervention (2) | Assessed with the online Program. Indicator of adherence: clicks | through study completion, an average of 16 weeks | 
| Adherence to Intervention (3) | Assessed with the online Program. Indicator of adherence: number of exercises completed | through study completion, an average of 16 weeks | 
| Anxiety Symptoms | Assessed with Patient Health Questionnaire - Anxiety (GAD-7; Löwe et al., 2002) | Baseline, 10 weeks, 16 weeks | 
| Stress Symptoms | Assessed with Patient Health Questionnaire - Stress (PHQ-Stress; Löwe et al., 2002) | Baseline, 10 weeks, 16 weeks | 
| Health | Assessed with Short Form Health Survey (SF-12; Gandek et al., 1998) | Baseline, 10 weeks, 16 weeks | 
| Suicidal Tendency | Assessed with Suicide Behaviors Questionnaire - Revised (SBQ-R; Glaesmer et al., 2017) | Baseline, 10 weeks, 16 weeks | 
| Social Problem Solving | Assessed with Social Problem Solving Inventory Revised (SPSI-R; D'Zurilla et al., 1999) | Baseline, 10 weeks, 16 weeks | 
| Satisfaction with treatment | Assessed with the german version of Client Satisfaction Questionnaire CSQ-8 (Attkisson & Zwick, 1982) | 10 weeks | 
| Negative Effects of Psychotherapy | Assessed with Inventory for the Assessment of Negative Effects of Psychotherapy (INEP; Ladwig, Rief, & Nestoriuc, 2014) | 10 weeks, 16 weeks | 
| Usability of Intervention | Assessed with System Usability Scale (SAS; Brooke, 1996) | 10 weeks |