Multifactorial Randomised Trial Investigating Outcome and Adherence Relevant Factors in an Online Problem-solving Self-help Intervention for Mild and Moderate Depressive Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change in Depressive Symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Online-Program + factors 1,2
In this "arm" two factors are set to "active" (i.e. yes):
- diagnostic interview
- motivational module
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 1,3,4
In this "arm" three factors are set to "active" (i.e. yes):
- diagnostic interview
- guidance
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
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
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
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
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 1,2,3
In this "arm" three factors are set to "active" (i.e. yes):
- diagnostic interview
- motivational module
- guidance
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factor 4
In this "arm" one factor is set to "active" (i.e. yes):
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 1,3
In this "arm" two factors are set to "active" (i.e. yes):
- diagnostic interview
- guidance
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 1,4
In this "arm" two factors are set to "active" (i.e. yes):
- diagnostic interview
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factor 1
In this "arm" one factor is set to "active" (i.e. yes):
- diagnostic interview
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 2,3,4
In this "arm" three factors are set to "active" (i.e. yes):
- motivational module
- guidance
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 2,3
In this "arm" two factors are set to "active" (i.e. yes):
- motivational module
- guidance
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 2,4
In this "arm" two factors are set to "active" (i.e. yes):
- motivational module
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factor 2
In this "arm" one factor is set to "active" (i.e. yes):
- motivational module
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factors 3,4
In this "arm" two factors are set to "active" (i.e. yes):
- guidance
- e-mail reminders
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + factor 3
In this "arm" one factor is set to "active" (i.e. yes):
- guidance
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
Online-Program + no factor
In this "arm" no factor is set to "active" (i.e. yes):
干预措施: HERMES (Online Self-Help Intervention based on problem-solving therapy) (Behavioral)
结局指标
主要结局
Change in Depressive Symptoms
时间窗: 16 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
时间窗: Baseline
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
时间窗: 2 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
时间窗: 4 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
Change in Depressive Symptoms
时间窗: 10 weeks
Assessed with Patient Health Questionnaire - Depression (PHQ-9; Kroenke, Spitzer \& Williams, 2001)
次要结局
- Adherence to Intervention (3)(through study completion, an average of 16 weeks)
- Anxiety Symptoms(Baseline, 10 weeks, 16 weeks)
- Adherence to Intervention (1)(through study completion, an average of 16 weeks)
- Adherence to Intervention (2)(through study completion, an average of 16 weeks)
- Health(Baseline, 10 weeks, 16 weeks)
- Stress Symptoms(Baseline, 10 weeks, 16 weeks)
- Satisfaction with treatment(10 weeks)
- Suicidal Tendency(Baseline, 10 weeks, 16 weeks)
- Social Problem Solving(Baseline, 10 weeks, 16 weeks)
- Usability of Intervention(10 weeks)
- Negative Effects of Psychotherapy(10 weeks, 16 weeks)