Testing e-Mental Health in Lebanon

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: Step-by-Step; Behavioral: Enhanced care as usual

• Registration Number: NCT03720769
• Lead Sponsor: VU University of Amsterdam

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-24
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Study Start: 2019-12-09
• Primary Completion: 2020-09-16
• Study Completion: 2020-12-20
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1248

Inclusion Criteria

• Age 18 or above
• PHQ-9 sum score above 9
• WHODAS 2.0 sum score above 16

Exclusion Criteria

• Serious thoughts or plans to end one's life

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Step-by-Step	Step-by-Step	-
Enhanced care as usual	Enhanced care as usual	-

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	8 weeks	Self-administered instrument for depression screening (intention-to-treat analysis)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	8 weeks	Generic assessment instrument for health and disability (intention-to-treat analysis)

Secondary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-6)	8 weeks
(Adapted) Client Service Receipt Inventory (CSRI)	8 weeks
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)	8 weeks
WHO-5 Well-Being Index	8 weeks
Self-defined psychosocial problems (PSYCHLOPS)	8 weeks

Trial Locations

Locations (1)

Ministry of Public Health; 🇱🇧 Beirut, Lebanon