Different Levels of Guidance in iCBT for Depression (RCT)
Condition: Depressive Symptoms; Quality of Life; Self Esteem
MeSH terms: Depression
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Selfapy with therapeutic guidance; Selfapy with additional peer support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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 with a therapeutic guide.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is a randomized controlled study with three conditions: Condition 1: Online intervention with therapeutic guidance (telephone contacts). Condition 2: Online intervention with additional peer support (online forum). Condition 3: Wait-list control group (access to the online intervention after completion of the post-assessment).
Two assessments-points, the intervention period (pre-post) is three months. At both assessments psychopathological data are obtained via the Internet survey Enterprise Feedback Suite survey by QuestBack Unipark®.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depressive symptoms, iCBT, guidance, peer-support, RCT