Testing e-Mental Health in Lebanon

Depression Clinical Trial

Official title:

Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720769
• Other study ID #: ERC.0002797
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: April 2021
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1248
• Est. completion date: December 20, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Step-by-Step
Guided self-help programme delivered through an app/website for the treatment of depression
• Enhanced care as usual
Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)

Locations

Country	Name	City	State
Lebanon	Ministry of Public Health	Beirut

Sponsors (4)

Lead Sponsor	Collaborator
VU University of Amsterdam	Freie Universität Berlin, Ministry of Public Health, Lebanon, World Health Organization

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire (CSQ-3)		only at post-assessment (8 weeks after baseline)
Primary	Patient Health Questionnaire (PHQ-9)	Self-administered instrument for depression screening (intention-to-treat analysis)	8 weeks
Primary	WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	Generic assessment instrument for health and disability (intention-to-treat analysis)	8 weeks
Secondary	WHO-5 Well-Being Index		8 weeks
Secondary	Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)		8 weeks
Secondary	PTSD Checklist for DSM-5 (PCL-6)		8 weeks
Secondary	Self-defined psychosocial problems (PSYCHLOPS)		8 weeks
Secondary	(Adapted) Client Service Receipt Inventory (CSRI)		8 weeks