Clinical trial NCT03720769: Testing e-Mental Health in Lebanon
Official title: Increasing Access to Mental Health Care for People Living in Lebanon: An E-Mental Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Ministry of Public Health, Lebanon
name: Freie Universität Berlin
First posted: 2018-10-25
Enrollment: 1248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 8 weeks
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 8 weeks
Secondary outcomes:
measure: WHO-5 Well-Being Index
timeFrame: 8 weeks
measure: Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
timeFrame: 8 weeks
measure: PTSD Checklist for DSM-5 (PCL-6)
timeFrame: 8 weeks
measure: Self-defined psychosocial problems (PSYCHLOPS)
timeFrame: 8 weeks
measure: (Adapted) Client Service Receipt Inventory (CSRI)
timeFrame: 8 weeks
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-3)
timeFrame: only at post-assessment (8 weeks after baseline)
Locations:
city: Beirut
country: Lebanon
facility: Ministry of Public Health
Study officials:
affiliation: VU Amsterdam
name: Pim Cuijpers, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cuijpers P, Heim E, Abi Ramia J, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial. PLoS Med. 2022 Jun 23;19(6):e1004025. doi: 10.1371/journal.pmed.1004025. eCollection 2022 Jun.
citation: Cuijpers P, Heim E, Ramia JA, Burchert S, Carswell K, Cornelisz I, Knaevelsrud C, Noun P, van Klaveren C, Van't Hof E, Zoghbi E, van Ommeren M, El Chammay R. Guided digital health intervention for depression in Lebanon: randomised trial. Evid Based Ment Health. 2022 Dec;25(e1):e34-e40. doi: 10.1136/ebmental-2021-300416. Epub 2022 May 16.
citation: van 't Hof E, Heim E, Abi Ramia J, Burchert S, Cornelisz I, Cuijpers P, El Chammay R, Harper Shehadeh M, Noun P, Smit F, van Klaveren C, van Ommeren M, Zoghbi E, Carswell K. Evaluating the Effectiveness of an E-Mental Health Intervention for People Living in Lebanon: Protocol for Two Randomized Controlled Trials. JMIR Res Protoc. 2021 Jan 28;10(1):e21585. doi: 10.2196/21585.