Testing e-Mental Health in Lebanon

VU University of Amsterdam

Status: Completed

Conditions: Depression

Treatments: Behavioral: Enhanced care as usual; Behavioral: Step-by-Step

Study type: Interventional

Funder types: Other

Identifiers

NCT03720769

ERC.0002797

Details and patient eligibility

About

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).

Enrollment: 1,248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,248 participants in 2 patient groups

Step-by-Step

Experimental group

Treatment:

Behavioral: Step-by-Step

Enhanced care as usual

Active Comparator group

Treatment:

Behavioral: Enhanced care as usual