Testing e-Mental Health in Lebanon

April 28, 2021 updated by: Pim Cuijpers, VU University of Amsterdam

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon
        • Ministry of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Client Satisfaction Questionnaire (CSQ-3)
Time Frame: only at post-assessment (8 weeks after baseline)
only at post-assessment (8 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VU University of Amsterdam

Collaborators

Freie Universität Berlin
World Health Organization
Ministry of Public Health, Lebanon

Investigators

  • Principal Investigator: Pim Cuijpers, Professor, VU Amsterdam

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2019

Primary Completion (Actual)

September 16, 2020

Study Completion (Actual)

December 20, 2020

Study Registration Dates

First Submitted

October 24, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERC.0002797

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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