Testing e-Mental Health in Lebanon

Study Overview
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Brief Summary
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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).

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Step-by-Step
* Behavioral: Enhanced care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Step-by-Step<br> | Behavioral: Step-by-Step<br>* Guided self-help programme delivered through an app/website for the treatment of depression<br>|
| Active Comparator: Enhanced care as usual<br> | Behavioral: Enhanced care as usual<br>* Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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