Testing e-Mental Health in Lebanon
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
Lebanon
Study Type
Interventional
Intervention
Step-by-Step
Enhanced care as usual
Sponsored by

About this trial
This is an interventional treatment trial for Depression
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
Sites / Locations
- Ministry of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Step-by-Step
Enhanced care as usual
Arm Description
Outcomes
Primary Outcome Measures
Patient Health Questionnaire (PHQ-9)
Self-administered instrument for depression screening (intention-to-treat analysis)
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Generic assessment instrument for health and disability (intention-to-treat analysis)
Secondary Outcome Measures
WHO-5 Well-Being Index
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
PTSD Checklist for DSM-5 (PCL-6)
Self-defined psychosocial problems (PSYCHLOPS)
(Adapted) Client Service Receipt Inventory (CSRI)
Full Information
NCT ID
NCT03720769
First Posted
October 24, 2018
Last Updated
April 28, 2021
Sponsor
VU University of Amsterdam
Collaborators
World Health Organization, Ministry of Public Health, Lebanon, Freie Universität Berlin
1. Study Identification
Unique Protocol Identification Number
NCT03720769
Brief Title
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
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VU University of Amsterdam
Collaborators
World Health Organization, Ministry of Public Health, Lebanon, Freie Universität Berlin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Step-by-Step
Arm Type
Experimental
Arm Title
Enhanced care as usual
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Step-by-Step
Intervention Description
Guided self-help programme delivered through an app/website for the treatment of depression
Intervention Type
Behavioral
Intervention Name(s)
Enhanced care as usual
Intervention Description
Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
Self-administered instrument for depression screening (intention-to-treat analysis)
Time Frame
8 weeks
Title
WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Description
Generic assessment instrument for health and disability (intention-to-treat analysis)
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
WHO-5 Well-Being Index
Time Frame
8 weeks
Title
Generalized Anxiety Disorder - 7 Questionnaire (GAD-7)
Time Frame
8 weeks
Title
PTSD Checklist for DSM-5 (PCL-6)
Time Frame
8 weeks
Title
Self-defined psychosocial problems (PSYCHLOPS)
Time Frame
8 weeks
Title
(Adapted) Client Service Receipt Inventory (CSRI)
Time Frame
8 weeks
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire (CSQ-3)
Time Frame
only at post-assessment (8 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pim Cuijpers, Professor
Organizational Affiliation
VU Amsterdam
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ministry of Public Health
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Citations:
PubMed Identifier
35737665
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. Erratum In: PLoS Med. 2023 Apr 14;20(4):e1004231.
Results Reference
derived
PubMed Identifier
35577536
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.
Results Reference
derived
PubMed Identifier
33507158
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.
Results Reference
derived
Learn more about this trial
Testing e-Mental Health in Lebanon
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