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Completed

NCT Number: NCT04551794

Different Levels of Guidance in iCBT for Depression (RCT)

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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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression Quality of Life Self Esteem

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjective psychological distress caused by depressive symptoms, wish for treatment, access to Internet, sufficient knowledge of the German language.

Exclusion criteria

Acute suicidal tendencies, lifetime diagnoses of schizophrenia or bipolar disorder, presence of neurological or dementia disease.

Treatment and study plan

Selfapy with therapeutic guidance

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.

Selfapy with additional peer support

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.

Primary outcomes

  1. Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)

    Time frame: 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).

  2. Change in depression measured with Beck Depression Inventory (BDI-II)

    Time frame: 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).

Secondary outcomes

  1. Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)

    Time frame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured

    The WHOQOL-BREF is a shorter version of the World Health Organization Quality of Life-100 (The WHOQOL Group 1998). It is composed of 26 self-report items measuring domains such as physical health, psychological health, social relationships and environment with the aim of measuring changes in quality of life over the course of treatment. Four different types of 5-point Likert scales are applied, asking "how much", "how complete", "how often", "how good" or "how satisfied" the person felt concerning the past two weeks. The WHOQOL-BREF has an internal consistency of .70 (Skevington, Lotfy, & O'Connell, 2004).

  2. Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)

    Time frame: Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)

    The German version of the Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8; Schmidt, Lamprecht, & Wittmann, 1989) is a self-report inventory that measures client satisfaction concerning the received treatment during inpatient stays. Each item could be answered on a 4-point Likert scale ranging from 1 (totally disagree) to 4 (totally agree). The internal consistency of the ZUF-8 ranges between 0.87-0.93 (Brähler, Schumacher, & Strauß, 2002).

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

iCBT for Depression: A Randomized Controlled Trial Comparing Different Levels of Guidance

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2020
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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