An interventional study of Step-by-Step and Enhanced care as usual in Depression, sponsored by VU University of Amsterdam. Completed at 1 site in Lebanon. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by VU University of Amsterdam · Not applicable, Interventional, and Treatment
The study objective is to test a guided e-mental health intervention called Step-by-Step for people living in Lebanon. Step-by-Step is a self-help programme delivered through an app or website and aims to treat symptoms of depression and other symptoms of psychological distress. First, a small study will be conducted to test the research procedure. Second, a large study will be conducted to test the effectiveness of Step-by-Step.
People residing in Lebanon (i.e. Lebanese, Palestinians and Syrian displaced people), above the age of 18 with symptoms of depression will be recruited through social media, posters, radio and television adverts, etc. Minors (under the age of 18) and people who have plans to end their life will be excluded from the study.
To test whether the use of Step-by-Step improves symptoms of depression, two groups will be compared. Participants in the intervention group will receive Step-by-Step, while those in the control group will receive basic information about depression and a list of health centres where they can get face-to-face help that is based on evidence. In addition, participants in the intervention group will receive weekly phone or chat support (up to 15 minutes) provided through lay helpers who were trained and work under the supervision of a trained clinical psychologist. The study hypothesises that participants who receive Step-by-Step will have a higher symptom improvement than participants who receive basic information.
In order to assess symptoms of depression and other symptoms of psychological distress, participants in this study will complete several questionnaires three times: At the beginning of the study, after 8 weeks, and then three months later (i.e. 5 months after the beginning of the study).
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 1,248 is above the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →VU University of Amsterdam is the lead sponsor of 47 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Step-by-Step
Behavioral: Enhanced care as usual
Guided self-help programme delivered through an app/website for the treatment of depression
Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)
Patient Health Questionnaire (PHQ-9)
Self-administered instrument for depression screening (intention-to-treat analysis)
Time frame: 8 weeks
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Generic assessment instrument for health and disability (intention-to-treat analysis)
Time frame: 8 weeks
WHO-5 Well-Being Index
Time frame: 8 weeks
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
Time frame: 8 weeks
PTSD Checklist for DSM-5 (PCL-6)
Time frame: 8 weeks
Self-defined psychosocial problems (PSYCHLOPS)
Time frame: 8 weeks
(Adapted) Client Service Receipt Inventory (CSRI)
Time frame: 8 weeks
Client Satisfaction Questionnaire (CSQ-3)
Time frame: only at post-assessment (8 weeks after baseline)
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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VU University of Amsterdam