Clinical trial NCT04551794: Different Levels of Guidance in iCBT for Depression (RCT)
Official title: iCBT for Depression: A Randomized Controlled Trial Comparing Different Levels of Guidance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Quality of Life
Self Esteem
Keywords: Depressive symptoms, iCBT, guidance, peer-support, RCT
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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®.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in depression measured with Patient Health Questionnaire 9 - Depression module (PHQ-9)
timeFrame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
measure: Change in depression measured with Beck Depression Inventory (BDI-II)
timeFrame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
Secondary outcomes:
measure: Change in quality of life measured with World Health Organization Quality Of Life - abbreviated version (WHOQOL-BREF)
timeFrame: Assesses symptoms over the last two weeks; provided at baseline and post (after 3 months); change from baseline to post is being measured
measure: Questionnaire to measure patient satisfaction (Fragebogen zur Patientenzufriedenheit, ZUF-8)
timeFrame: Assesses patient satisfaction with the program at the time of assessment; provided only at post (3 months after baseline)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Germany
name: Steffen Moritz, Prof.
role: PRINCIPAL_INVESTIGATOR
References: