iCBT for Depression: A Randomized Controlled Trial Comparing Different Levels of Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)
研究概览
简要总结
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions. The groups were organized into one wait-list control group and two groups receiving access to Selfapy with different levels of guidance.
详细描述
The study examines the effectiveness of a internet-based self-help-program called Selfapy for individuals who are experiencing mental stress. The main objective of the study is to investigate the extent to which Selfapy leads to a significant reduction in depressive symptoms. As this study is the first to evaluate the program Selfapy, also quality of life and acceptance of the program are evaluated. The primary outcome is the PHQ-9 as a measure of the severity of depressive symptoms, combined with the BDI-II. Secondary outcomes are rates of quality of life and satisfaction with the program, which were measured with the WHOQOL-BREF and ZUF-8. The study is conducted as a randomized-controlled trial with parallel assignment into three conditions over the course of three months. The groups were organized into one wait-list control group, one that received Selfapy with additional peer support and one that received Selfapy with therapeutic guidance.The wait-list control group received access to the program after completion of the post-survey.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking was not necessary as the participants were automatically randomized within the baseline assessment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.
排除标准
- •Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.
研究组 & 干预措施
Online self-help program with additional peer support
The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum.
干预措施: Selfapy with additional peer support (Behavioral)
No intervention: waitlist-control group
The participants of the wait-list control condition do not receive any new intervention during the intervention period of 9 weeks, but may continue any treatment that has already been started before, including medication. Participants in the wait-list control condition receive full access to the program after completion of the post-assessment.
Online self-help program with therapeutic guidance
The intervention group receives the login data for the online program directly following the baseline assessment. The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences and difficulties concerning the program on a weekly basis with a therapeutic guide on the phone.
干预措施: Selfapy with therapeutic guidance (Behavioral)
结局指标
主要结局
Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)
时间窗: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
The PHQ-9 (Kroenke et al. 2001) is made up of 9 items which could be self-rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day). Major depression and other depression diagnoses according to DSM-IV can be determined according to the overall score. Sum scores of 0-4 indicate none or minimal depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, and 15-27 severe depressive symptoms. Its internal consistency ranges from 0.86-0.89 (Smarr and Keefer 2011).
Change in depression measured with Beck Depression Inventory (BDI-II)
时间窗: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
The BDI-II (Beck et al., 1996) is a 21-item self-report inventory measuring the severity of depression in adolescents and adults. Each item is rated on a four-point Likert scale ranging from 0 (symptom not present) to 3 (symptom very intense). The BDI assesses psychological and physical symptoms over the last two weeks in order to quantify levels of depression. An overall score of 0-13 indicates minimal depression, a score of 14-19 indicates mild depression, a score of 20-28 moderate depression and total scores of 29-63 suggest severe depression. The internal consistency of the BDI-II ranges from 0.79-0.90 (Smarr and Keefer 2011).
次要结局
- Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)(Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured)
- Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)(Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline))