Different Levels of Guidance in iCBT for Depression (RCT)

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

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-15

Study Completion Date

2016-12-09

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Depressive Symptoms Quality of Life Self Esteem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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®.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Masking was not necessary as the participants were automatically randomized within the baseline assessment.

Study Groups

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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.

Group Type EXPERIMENTAL

Selfapy with additional peer support

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Selfapy with therapeutic guidance

Intervention Type BEHAVIORAL

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.

Interventions

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Selfapy with therapeutic guidance

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.

Intervention Type BEHAVIORAL

Selfapy with additional peer support

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.

Intervention Type BEHAVIORAL