search
Back to results

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
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

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
search

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

We'll reach out to this number within 24 hrs