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Clinical Trials/NCT03720769
NCT03720769
Completed
N/A

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

VU University of Amsterdam1 site in 1 country1,248 target enrollmentDecember 9, 2019
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
VU University of Amsterdam
Enrollment
1248
Locations
1
Primary Endpoint
Patient Health Questionnaire (PHQ-9)
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
December 9, 2019
End Date
December 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
VU University of Amsterdam
Responsible Party
Principal Investigator
Principal Investigator

Pim Cuijpers

Professor

VU University of Amsterdam

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

Outcomes

Primary Outcomes

Patient Health Questionnaire (PHQ-9)

Time Frame: 8 weeks

Self-administered instrument for depression screening (intention-to-treat analysis)

WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

Time Frame: 8 weeks

Generic assessment instrument for health and disability (intention-to-treat analysis)

Secondary Outcomes

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

Study Sites (1)

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