Different Levels of Guidance in iCBT for Depression (RCT)

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Depressive Symptoms; Self Esteem
• Intervention / Treatment: Behavioral: Selfapy with additional peer support; Behavioral: Selfapy with therapeutic 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • University Medical Center Hamburg-Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)	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).	Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Change in depression measured with Beck Depression Inventory (BDI-II)	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).	Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)	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).	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)	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).	Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Steffen Moritz, Prof., University Medical Center Hamburg-Eppendorf, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2016
• Primary Completion (Actual): December 9, 2016
• Study Completion (Actual): December 9, 2016

Study Registration Dates

• First Submitted: August 29, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Depressive symptoms, iCBT, guidance, peer-support, RCT
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: Selfapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No